NCT05064800
|
PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants |
Completed |
Phase 1 |
Sep/21/2021 |
Dec/06/2021 |
- Alternative id - C4671012
- Interventions - Drug: Dabigatran|Drug: PF-07321332/ritonavir + Dabigatran|Drug: Ritonavir + Dabigatran
- Study type - Interventional
- Study results - No Results Available
- Locations - Research Centers of America ( Hollywood ), Hollywood, Florida, United States
- Study designs - Allocation: Non-Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 24
- Age - 18 Years to 60 Years (Adult)
- Outcome measures - Area under the curve from time zero to infinity (AUCinf) of dabigatran when administer with PF-07321332/ritonavir|Maximum Observed Plasma Concentration (Cmax) of dabigatran when administered with PF-07321332/ritonavir|AUCinf of dabigatran when administered with multiple doses of ritonavir|Cmax of dabigatran when administered with multiple doses of ritonavir|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Number of Participants With Abnormalities in Physical Examination|Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings|Time to Reach Maximum Observed Plasma Concentration (Tmax) of dabigatran|Plasma Decay Half-Life (t1/2) of dabigatran|Cmax of PF-07321332|AUCtau (area under the curve of the dosing interval) of PF-0321332|Tmax of PF-0321332|T1/2 of PF-0321332|Apparent Oral Clearance (CL/F) of PF-0321332|Apparent Volume of Distribution (Vz/F) of PF-0321332
|
NCT04291729
|
Evaluation of Ganovo (Danoprevir ) Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection |
Completed |
Phase 4 |
Feb/17/2020 |
Mar/19/2020 |
- Alternative id - ASC-CTP-NC-01
- Interventions - Drug: Ganovo+ritonavir+/-Interferon nebulization
- Study type - Interventional
- Study results - No Results Available
- Locations - The Ninth Hospital of Nanchang, Nanchang, Jiangxi, China
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 11
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Rate of composite adverse outcomes|Time to recovery|Rate of no fever|Rate of no cough|Rate of no dyspnea|Rate of no requiring supplemental oxygen|Rate of undetectable New coronavirus pathogen nucleic acid|Rate of mechanical ventilation|Rate of ICU admission|Rate of serious adverse event
|
NCT04251871
|
Treatment and Prevention of Traditional Chinese Medicines (TCMs) on COVID-19 Infection |
Recruiting |
Not Applicable |
Jan/22/2020 |
Jan/22/2021 |
- Alternative id - 2020001D
- Interventions - Drug: Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir) and Traditional Chinese Medicines (TCMs) granules|Drug: Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir)
- Study type - Interventional
- Study results - No Results Available
- Locations - The Fifth Medical Center, General Hospital of PLA, Beijing, Beijing, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 150
- Age - 14 Years to 80 Years (Child, Adult, Older Adult)
- Outcome measures - The incidents of acute respiratory distress syndrome (ARDS) development|The time to fever resolution rate|Time to recovery of lung injury
|
NCT04350684
|
Umifenovir in Hospitalized COVID-19 Patients |
Enrolling by invitation |
Phase 4 |
Apr/15/2020 |
Apr/24/2020 |
- Alternative id - Umifenovir in COVID-19
- Interventions - Drug: Umifenovir|Drug: Interferon-β 1a|Drug: Lopinavir / Ritonavir|Drug: Single Dose of Hydroxychloroquine|Drug: Standards of Care
- Study type - Interventional
- Study results - No Results Available
- Locations - Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services, Tehran, Iran, Islamic Republic of
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 40
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Time to clinical improvement|Mortality|SpO2 Improvement|Incidence of new mechanical ventilation use|Duration of hospitalization|Cumulative incidence of serious adverse events
|
NCT05011812
|
Study of PBI-0451 in Healthy Subjects. |
Recruiting |
Phase 1 |
Aug/14/2021 |
May/31/2022 |
- Alternative id - PBI-0451-0001
- Interventions - Drug: PBI-0451 Dose 1|Drug: PBI-0451 Dose 2|Drug: PBI-0451 Dose 3|Drug: PBI-0451 Dose 4|Drug: Ritonavir|Drug: Midazolam|Drug: Placebo|Drug: PBI-0451|Drug: PBI-0451 Dose 5
- Study type - Interventional
- Study results - No Results Available
- Locations - Auckland City Hospital, Auckland, New Zealand
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 120
- Age - 18 Years to 59 Years (Adult)
- Outcome measures - Number of subjects with treatment emergent adverse events (TEAEs) in Single Ascending Dose (SAD) compared to placebo|Number of subjects with clinically significant change from Baseline in vital signs in SAD|Number of patients with laboratory abnormalities in SAD|Number of subjects with treatment emergent adverse events (TEAEs) in Multiple Ascending Dose (MAD) compared to placebo|Number of subjects with clinically significant change from Baseline in vital signs in MAD|Number of patients with laboratory abnormalities in MAD|To collect ECG data for PBI-0451 for the purpose of concentration-QT/QTc modeling|Plasma concentration of each dose of study drug to determine AUCinf in SAD|Plasma concentration of each dose of study drug to determine AUClast in SAD|Plasma concentration of each dose of study drug to determine %AUCexp in SAD|Plasma concentration of each dose of study drug to determine CL/F in SAD|Plasma concentration of each dose of study drug to determine CLss/F in MAD|Plasma concentration of each dose of study drug to determine AUCtau in MAD|Plasma concentration of each dose of study drug to determine Cmax in MAD|Plasma concentration of each dose of study drug to determine Tmax in MAD|Plasma concentration of each dose of study drug to determine Tlast in MAD|Plasma concentration of each dose of study drug to determine Clast in MAD|Plasma concentration of each dose of study drug to determine Ctau in MAD|Plasma concentration of each dose of study drug to determine λz in MAD|Plasma concentration of each dose of study drug to determine t1/2|Plasma concentration of each dose of study drug to determine Vz/F
|
NCT05047601
|
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection |
Recruiting |
Phase 3 |
Sep/09/2021 |
Apr/18/2022 |
- Alternative id - C4671006|2021-002894-24|EPIC-PEP
- Interventions - Drug: PF-07321332|Drug: Placebo for PF-07321332|Drug: Placebo for Ritonavir|Drug: Ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations - Cahaba Research, Inc., Pelham, Alabama, United States|The Institute for Liver Health dba Arizona Clinical Trials, Mesa, Arizona, United States|The Institute for Liver Health dba Arizona Clinical Trials, Tucson, Arizona, United States|KLR Business Group, Inc. dba Arkansas Clinical Research, Little Rock, Arkansas, United States|Hope Clinical Research, Canoga Park, California, United States|Lightship, El Segundo, California, United States|Ascada Health PC, Fullerton, California, United States|Ark Clinical Research, Long Beach, California, United States|American Institute of Research, Los Angeles, California, United States|FOMAT Medical Research, Oxnard, California, United States|Optimus Medical Group, San Francisco, California, United States|South Bay Clinical Research Institute, Torrance, California, United States|Hope Clinical Research (COVID Satellite Location), West Hills, California, United States|Future Innovative Treatments, LLC, Colorado Springs, Colorado, United States|BRB Health Group DBA Broward Research Center, Aventura, Florida, United States|Synergy Healthcare, Bradenton, Florida, United States|MOORE Clinical Research, Inc., Brandon, Florida, United States|Innovative Research of West Florida, Inc., Clearwater, Florida, United States|Herco Medical and Research Center Inc, Coral Gables, Florida, United States|Advance Clinical Research Group, Cutler Bay, Florida, United States|Beautiful Minds Clinical Research Center, Cutler Bay, Florida, United States|Midland Florida Clinical Research Center, LLC, DeLand, Florida, United States|Unlimited Medical Research Group, LLC, Hialeah Gardens, Florida, United States|Qway Research, LLC, Hialeah, Florida, United States|Eastern Research Inc, Hialeah, Florida, United States|Inpatient Research Clinic, Hialeah, Florida, United States|Doral Medical Research,LLC, Hialeah, Florida, United States|Advanced Pulmonary Research Institute, Loxahatchee Groves, Florida, United States|Asclepes Research Centers, Lutz, Florida, United States|Pro-Care Research Center, Corp., Miami Gardens, Florida, United States|Lakes Research, LLC., Miami Lakes, Florida, United States|Savin Medical Group, LLC, Miami Lakes, Florida, United States|Angels Clinical Research Institute, Miami, Florida, United States|Nova Life Med Spa, Miami, Florida, United States|LCC Medical Research Institute, LLC, Miami, Florida, United States|Premium Medical Research Corp, Miami, Florida, United States|Global Health Clinical Trials Corp, Miami, Florida, United States|South Florida Research Center, Inc., Miami, Florida, United States|Suncoast Research Group, LLC, Miami, Florida, United States|University of Miami Health System, Miami, Florida, United States|I.V.A.M. Clinical & Investigational Center, LLC, Miami, Florida, United States|Medical Research of Westchester Inc, Miami, Florida, United States|C'A Research, Miami, Florida, United States|ProLive Medical Research, Corp., Miami, Florida, United States|Entrust Clinical Research, Miami, Florida, United States|Reed Medical Research, Miami, Florida, United States|Kendall South Medical Center, Inc., Miami, Florida, United States|Clinical Site Partners, Inc dba CSP Miami, Miami, Florida, United States|Coral Research Clinic Corp, Miami, Florida, United States|Omega Research Orlando, Orlando, Florida, United States|NAPA Research LLC, Pompano Beach, Florida, United States|CDC Research Institute, LLC, Port Saint Lucie, Florida, United States|GCP, Global Clinical Professionals, Saint Petersburg, Florida, United States|GCP, Global Clinical Professionals, Saint Petersburg, Florida, United States|Accel Research Sites - St. Petersburg Clinical Research Unit, Saint Petersburg, Florida, United States|Professional Urgent Care Services, Saint Petersburg, Florida, United States|USPA Advance Concept Medical Research Group LLC, South Miami, Florida, United States|Asclepes Research Centers, Spring Hill, Florida, United States|Sunrise Research Institute, Sunrise, Florida, United States|Tampa General Hospital, Tampa, Florida, United States|Santos Research Center, CORP, Tampa, Florida, United States|Palm Beach Research Center, West Palm Beach, Florida, United States|Clinical Site Partners, Inc, Winter Park, Florida, United States|Research by Design, LLC, Chicago, Illinois, United States|The South Bend Clinic Center for Research, South Bend, Indiana, United States|Accellacare, Ames, Iowa, United States|McFarland Clinic, PC, Ames, Iowa, United States|WKB Family Medicine Associates, Bossier City, Louisiana, United States|New Orleans Sinus Center (COVID-19 Testing), Marrero, Louisiana, United States|Tandem Clinical Research GI, LLC, Marrero, Louisiana, United States|Southern Clinical Research Associates, LLC, Metairie, Louisiana, United States|MedPharmics LLC, Metairie, Louisiana, United States|Willis-Knighton Health System, Shreveport, Louisiana, United States|Michigan Center of Medical Research, Farmington Hills, Michigan, United States|Jackson Medical Mall, Jackson, Mississippi, United States|Lakeland Pharmacy, Branson W., Missouri, United States|Price Cutter, Springfield, Missouri, United States|Mercury Street Medical Group, PLLC, Butte, Montana, United States|Meridian Clinical Research, LLC, Grand Island, Nebraska, United States|Quality Clinical Research Inc, Omaha, Nebraska, United States|Quality Clinical Research, Omaha, Nebraska, United States|Walmart, Las Vegas, Nevada, United States|Excel Clinical Research, Las Vegas, Nevada, United States|Walgreens, Las Vegas, Nevada, United States|Meridian Clinical Research, LLC, Endwell, New York, United States|NYC Health + Hospitals/Harlem, New York, New York, United States|Monroe Biomedical Research, Monroe, North Carolina, United States|Accellacare, Wilmington, North Carolina, United States|Innovo Research: Wilmington Health, Wilmington, North Carolina, United States|Premier Medical Group, Clarksville, Tennessee, United States|PharmaTex Research, LLC, Amarillo, Texas, United States|ARC Clinical Research at William Cannon, Austin, Texas, United States|St Hope Foundation, Bellaire, Texas, United States|Conroe Willis Medical Research, Conroe, Texas, United States|South Texas Clinical Research, Corpus Christi, Texas, United States|Brooke Army Medical Center, Fort Sam Houston, Texas, United States|SingnatureCare Emergency Center, Houston, Texas, United States|Trio Clinical Trials, LLC, Houston, Texas, United States|C & R Research Services USA, Houston, Texas, United States|Next Level Urgent Care, Houston, Texas, United States|SMS Clinical Research, LLC, Mesquite, Texas, United States|LinQ Research, LLC, Pearland, Texas, United States|Epic Medical Research, Red Oak, Texas, United States|Sun Research Institute, San Antonio, Texas, United States|Endeavor Clinical Trials, LLC, San Antonio, Texas, United States|BFHC Research, San Antonio, Texas, United States|Tranquility Research, Webster, Texas, United States|University of Utah Medical Center, Salt Lake City, Utah, United States|TPMG Clinical Research, Newport News, Virginia, United States|Centro Medico Viamonte SRL, Caba, Buenos Aires, Argentina|DIM Clinica Privada, Ramos Mejia. La Matanza, Buenos Aires, Argentina|Instituto de Investigaciones Clinicas Zarate, Zarate, Buenos Aires, Argentina|Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos), Rosario, Santa FE, Argentina|Sanatorio Britanico, Rosario, Santa FE, Argentina|Instituto CAICI, Rosario, Santa FE, Argentina|Hospital de Clinicas Presidente Nicolas Avellaneda, San Miguel de Tucuman, Tucuman, Argentina|Clinica Mayo de UMCB SRL, San Miguel de Tucuman, Tucuman, Argentina|Sanatorio Britanico S.A., Rosario, Argentina|Fundação de Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, Amazonas, Brazil|Hospital Universitario Prof. Edgard Santos/ Universidade Federal da Bahia, Salvador, Bahia, Brazil|Hospital Cardio Pulmonar, Salvador, Bahia, Brazil|Chronos Pesquisa Clinica, Brasilia, Distrito Federal, Brazil|AMB3 Serviços Médicos Ltda, Cuiabá, MATO Grosso, Brazil|Hospital Luxemburgo - Associacao Mario Penna, Belo Horizonte, MG, Brazil|Infection Control Ltda, Belo Horizonte, Minas Gerais, Brazil|School of Medicine Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil|Hospital Agamenon Magalhaes, Recife, Pernambuco, Brazil|Centro de Estudos e Pesquisas em Moléstias Infecciosas, Natal, RIO Grande DO Norte, Brazil|Hospital De Clinicas De Porto Alegre, Porto Alegre, RIO Grande DO SUL, Brazil|IBPClin- Instituto Brasil de Pesquisa Clinica, Rio de Janeiro, RJ, Brazil|Instituto Nacional de Infectologia Evandro Chagas - INI/FIOCRUZ, Rio de Janeiro, RJ, Brazil|CECOR - Centro Oncológico de Roraima, Boa Vista, Roraima/rr, Brazil|Centro de Estudos Clinicos do Interior Paulista (CECIP), Jau, SAO Paulo, Brazil|Hospital Dia do Pulmao, Blumenau, SC, Brazil|Hospital Regional Hans Dieter Schmidt (HRHDS), Joinville, SC, Brazil|Hospital e Maternidade Celso Pierro - PUC Campinas / Sociedade Campineira de Educação e Instruçã, Campinas, SP, Brazil|Pesquisare Saude S/S Ltda, Santo André, SP, Brazil|Hospital Alemao Oswaldo Cruz, São Paulo, SP, Brazil|Unidade Referenciada Oswaldo Cruz Vergueiro, São Paulo, SP, Brazil|Hospital Heliópolis, São Paulo, SP, Brazil|Instituto D'Or de Pesquisa e Ensino / Hospital São Luiz Jabaquara, São Paulo, SP, Brazil|Scentryphar - Pesquisa Clínica, Campinas, SÃO Paulo, Brazil|Associação Evangélica de Campinas - Hospital Samaritano, Campinas, SÃO Paulo, Brazil|Instituto de Pesquisa Clínica de Campinas, Campinas, SÃO Paulo, Brazil|Centro de Referência e Treinamento DST/AIDS, Sao Paulo, SÃO Paulo, Brazil|Clinica de Alergia Martti Antila, Sorocaba, SÃO Paulo, Brazil|CEMEC - Centro Multidisciplinar de Estudos Clínicos, São Bernardo do Campo, SÃO Paulo, Brazil|Hospital Anchieta, São Bernardo do Campo, SÃO Paulo, Brazil|CPCLIN - Centro de Pesquisas Clinicas Ltda, São Paulo, Brazil|Instituto de Infectologia Emilio Ribas, São Paulo, Brazil|Conjunto Hospitalar do Mandaqui, São Paulo, Brazil|Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD, Burgas, Bulgaria|MHAT St. Ekaterina, Dimitrovgrad EOOD, Dimitrovgrad, Bulgaria|"Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd, Haskovo, Bulgaria|MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD, Kozloduy, Bulgaria|Diagnostic-Consultative Center I Lom EOOD, Lom, Bulgaria|Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD, Lom, Bulgaria|Medical centre Leo Clinic EOOD, Lovech, Bulgaria|MHAT Heart and Brain EAD, Pleven, Bulgaria|UMHAT Sveta Marina - Pleven, Pleven, Bulgaria|DCC Sveti Georgi EOOD, Plovdiv, Bulgaria|MHAT "St. Panteleimon "- Plovdiv, Plovdiv, Bulgaria|Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD, Razgrad, Bulgaria|"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -, Ruse, Bulgaria|UMHAT Medica Ruse OOD, Ruse, Bulgaria|Multiprofile Hospital for Active Treatment - Samokov EOOD, Samokov, Bulgaria|Medical Center-1-Sevlievo EOOD, Sevlievo, Bulgaria|Multiprofile Hospital For Active Treatment Shumen AD, Shumen, Bulgaria|Multiprofile hospital for active treatment - Sliven to Military Medical Academy, Sliven, Bulgaria|MHAT "Dr. Ivan Seliminski" AD, Sliven, Sliven, Bulgaria|Diagnostic-Consultative Center XXII- Sofia ЕООD, Sofia, Bulgaria|University First MHAT "St. Yoan Krastitel"-Sofia EAD, Sofia, Bulgaria|UMHATEM N. I. Pirogov EAD, Sofia, Bulgaria|MHAT "St. Sofia" EOOD, Sofia, Bulgaria|Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD, Stara Zagora, Bulgaria|Multiprofile Hospital for Active Treatment Targovishte AD, Targovishte, Bulgaria|Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD, Tsarevo, Bulgaria|Medical center Leo Clinic EOOD, Varna, Bulgaria|MOBAL "D-r Stefan Cherkezov" AD, Veliko Tarnovo, Bulgaria|Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD, Vratsa, Bulgaria|Fundacion Centro de Investigacion Clinica CIC, Medellin, Antioquia, Colombia|Centro Cardivascular Colombiano-Clinica Santa Maria, Medellin, Antioquia, Colombia|Clinica de la Costa LTDA., Barranquilla, Atlantico, Colombia|Hospital Universidad Del Norte, Soledad, Atlantico, Colombia|IPS Medicos Internistas de Caldas, Manizales, Caldas, Colombia|Caimed S.A.S., Yopal, Casanare, Colombia|Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S, Bogota, Cundinamarca, Colombia|Bluecare Salud S A S, Bogota, D.C, Colombia|Fundacion Cardiomet CEQUIN, Armenia, Quindio, Colombia|Instituto de investigaciones Centro Medico Imbanaco, Cali, Valle DEL Cauca, Colombia|Doktor Brno s.r.o., Brno, Czechia|Fakultni nemocnice Hradec Kralove, Hradec Kralove, Czechia|MEDITRIAL s.r.o., Jindrichuv Hradec III, Czechia|Zdraví-Fit, s.r.o., Protivín, Czechia|Nemocnice Slany, Slany, Czechia|Trial Pharma Kft., Bekescsaba, Hungary|Semmelweis University Varosmajori Sziv Es Ergyogyaszati Klinika, Budapest, Hungary|Varosmajori Sziv- es Ergyogyaszati Klinika, Budapest, Hungary|Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika, Debrecen, Hungary|Agria-Study Kft., Eger, Hungary|Trial Pharma Kft., Gyula, Hungary|Medifarma-98 Kft., Nyiregyhaza, Hungary|International University of Health and Welfare Narita Hospital, Narita, Chiba, Japan|Rakuwakai Otowa Hospital, Kyoto-shi, Kyoto, Japan|Rinku General Medical Center, Izumisano, Osaka, Japan|Denenchofu Family Clinic, Ota, Tokyo, Japan|Tokyo Shinagawa Hospital, Shinagawa-ku, Tokyo, Japan|Sekino Hospital, Toshimaku, Tokyo, Japan|Kyushu Medical Center, Fukuoka, Japan|Kyungpook National University Chilgok Hospital, Daegu, Korea, Republic of|Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan, Malaysia|Klinik Kesihatan Greentown, Ipoh, Perak, Malaysia|Hospital Seberang Jaya, Seberang Jaya, Pulau Pinang, Malaysia|Hospital Miri, Miri, Sarawak, Malaysia|Klinik Kesihatan Kuang, Sungai Buloh, Selangor, Malaysia|InfectoLab Consultorios de Especialidad en Infectologia, Tijuana, BAJA California, Mexico|Clinical Research Institute Saltillo S.A. de C.V., Saltillo, Coahuila, Mexico|Centro de Investigacion Clinica Del Pacifico SA de CV, Acapulco de Juarez, Guerrero, Mexico|Asociacion Mexicana para la Investigacion Clinica, A. C., Pachuca de Soto, Hidalgo, Mexico|Instituto Jalisciense de Metabolismo, S.C., Guadalajara, Jalisco, Mexico|JM Research, Cuernavaca, Morelos, Mexico|Centro Médico Jojutla (Hospital Regional Jojutla)., Jojutla, Morelos, Mexico|Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Nuevo LEON, Mexico|Eukarya Pharmasite S.C., Monterrey, Nuevo LEON, Mexico|Christus- Latam Hub Center of Excellence and Innovation Center S.C., Monterrey, Nuevo LEÓN, Mexico|Oaxaca site management organization s.c, Oaxaca de Juarez, Oaxaca, Mexico|Hospital General de Culiacán "Bernardo J. Gastélum", Culíacan, Sinaloa, Mexico|Kohler & Milstein Research S.A. de C.V., Merida, Yucatan, Mexico|Eme Red Hospitalaria, Mérida, Yucatán, Mexico|Hospital Cardiologica Aguascalientes, Aguascalientes, Mexico|Instituto de Investigaciones Clínicas para la Salud, Durango, Mexico|FAICIC Clinical Research, Veracruz, Mexico|Sociedad de Metabolismo y Corazon S.C., Veracruz, Mexico|Arke SMO S.A. de C.V, Veracruz, Mexico|KLIMED Marek Klimkiewicz, Bialystok, Poland|Krakowskie Centrum Medyczne, Krakow, Poland|Przychodnia Valeo Medical, Lodz, Poland|IRMED Ośrodek Badań Klinicznych, Piotrkow Trybunalski, Poland|Tomasz Blicharski Lubelskie Centrum Diagnostyczne, Swidnik, Poland|WIP Warsaw IBD Point Profesor Kierkus, Warszawa, Poland|Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska, Wroclaw, Poland|Ponce Medical School Foundation, Inc. CAIMED Center, Ponce, Puerto Rico|Clinical Research Management Group Inc, Ponce, Puerto Rico|Advance Medical Research Center, San Juan, Puerto Rico|Kirovsk Interdistrict Hospital, Kirovsk, Leningrad Region, Russian Federation|LLC Trekhgorka Medicine, Odintsovo, Moscow Region, Russian Federation|Private Medical Institution "Euromedservice", Pushkin, Saint-petersburg, Russian Federation|Clinica UZI 4D, Pyatigorsk, Stavropol Region, Russian Federation|Barnaul City Hospital Number 5, Barnaul, Russian Federation|Korolev Medicine, Korolev, Russian Federation|KDC "Evromedservis", OJSC, Moscow, Russian Federation|City Polyclinic #44, Saint Petersburg, Russian Federation|LLC Strategic Medical Systems, Saint Petersburg, Russian Federation|Medical Research Institute, LLC, Saint Petersburg, Russian Federation|City Polyclinic No. 109, Saint-Petersburg, Russian Federation|Limited Liability Company "Center for Diagnostics and Rehabilitation "Praximed", Saint-Petersburg, Russian Federation|City Out-patient clinic #112, Saint-Petersburg, Russian Federation|"Research Center Eco-safety" LLC, Saint-Petersburg, Russian Federation|LLC Kurator, Saint-Petersburg, Russian Federation|Saint-Petersburg State Budgetary Healthcare Institution "City Pokrovskaya hospital", Saint-Petersburg, Russian Federation|Astarta LLC, Saint-Petersburg, Russian Federation|City Out-patient clinic #4, Saint-Petersburg, Russian Federation|Smolensk State Medical University, Smolensk, Russian Federation|LLC Family clinic, Yekaterinburg, Russian Federation|Global Clinical Trials, Gqeberha, Eastern CAPE, South Africa|Nelson Mandela Academic Clinical Research Unit (NeMACRU), Mthatha, Eastern CAPE, South Africa|MERC Welkom, Welkom, FREE State, South Africa|Worthwhile Clinical Trials, Benoni, Gauteng, South Africa|REIMED Vosloorus, Boksburg, Gauteng, South Africa|Lenasia Clinical Trial Centre, Johannesburg, Gauteng, South Africa|LCS Clinical Research, Johannesburg, Gauteng, South Africa|Peermed CTC (Pty) Ltd T/A MERC Kempton, Kempton Park, Gauteng, South Africa|Midrand Medical Centre, Midrand, Gauteng, South Africa|About Allergy (PTY) Ltd, Pretoria North, Gauteng, South Africa|Global Clinical Trials, Pretoria, Gauteng, South Africa|Botho ke Bontle Health Services, Pretoria, Gauteng, South Africa|Emmed Research, Pretoria, Gauteng, South Africa|Into Research, Pretoria, Gauteng, South Africa|Clinical Trial Systems (Pty) Ltd, Pretoria, Gauteng, South Africa|Sandton Medical Clinic, Sandton, Gauteng, South Africa|FCRN Clinical Trial Centre, Vereeniging, Gauteng, South Africa|Dr PJ Sebastian Clinical Research Centre, Durban, Kwa-zulu Natal, South Africa|Synapta Clinical Research Center, Durban, Kwazulu Natal, South Africa|Ahmed Al-Kadi Private Hospital, Mayville, Durban, Kwazulu-natal, South Africa|Private Practice - Dr. Jeevren Reddy, Stanger, Kwazulu-natal, South Africa|Limpopo Clinical Research Initiative, Thabazimbi, Limpopo, South Africa|NHC Thohoyandou CRS, Thohoyandou, Limpopo, South Africa|MERC Middelburg, Middelburg, Mpumalanga, South Africa|Madibeng Centre for Research, Brits, North WEST, South Africa|TASK Applied Science, Cape Town, Western CAPE, South Africa|Red Zone Clinic, Cape Town, Western CAPE, South Africa|Tiervlei Trial Centre, Cape Town, Western CAPE, South Africa|TASK Eden, George, Western CAPE, South Africa|Be Part Research Pty (Ltd), Paarl, Western CAPE, South Africa|Clinical Projects Research, Worcester, Western CAPE, South Africa|Synopsis Research, Claremont, South Africa|Dr JM Engelbrecht Trial Site, Somerset West, South Africa|Eba Centelles, Centelles, Barcelona [barcelona], Spain|CAP Vicenç Papaceit, La Roca del Valles, Barcelona, Spain|CAP La Mina, Sant Adria de Besos, Barcelona, Spain|Hospital Universitario Mutua de Terrassa, Terrassa, Barcelona, Spain|Hospital Alvaro Cunqueiro, Vigo, Pontevedra, Spain|IMED Valencia, Burjassot, Valencia, Spain|Complexo Hospitalario Universitario da Coruna, A Coruña, Spain|Hospital Universitario Virgen de las Nieves, Granada, Spain|Hospital Universitario de la Paz, Madrid, Spain|Hospital Universitario Virgen de Valme, Sevilla, Spain|Far Eastern Memorial Hospital, New Taipei City, Taiwan|China Medical University Hospital, Taichung, Taiwan|Taichung Veterans General Hospital, Taichung, Taiwan|National Taiwan University Hospital, Taipei, Taiwan|National Taiwan University Hospital, Taipei, Taiwan|Bangkok Centre Hotel, Bangrak, Bangkok, Thailand|Chula Filed hospital, Chulalongkorn University Sport center (Chantanayingyong Gymnasium),, Pathum Wan District,, Bangkok, Thailand|Thai Red Cross Emerging Infectious Diseases (EDI) Clinic, Pathumwan,, Bangkok, Thailand|The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),, Pathumwan, Bangkok, Thailand|Faculty of Medicine - Khon Kaen University, Muang, Khon Kaen, Thailand|Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,, Hat Yai, Songkhla, Thailand|King Chulalongkorn Memorial Hospital, Bangkok, Thailand|Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand|Tropical Medicine Hospital, Bangkok, Thailand|Cukurova University Medical Faculty, Balcali, Adana, Turkey|Ankara University Medical Faculty, Ibni-Sina Hospital, Ankara, Turkey|Hacettepe University Medical Faculty Hospital, Ankara, Turkey|Akdeniz Universitesi Hastanesi, Antalya, Turkey|Istanbul University Istanbul Medical Faculty, Fatih / Istanbul, Turkey|Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi, Gaziantep, Turkey|Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi, Istanbul, Turkey|Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty, Istanbul, Turkey|Medipol Mega University Hospital, Istanbul, Turkey|Acibadem University Atakent Hospital, Istanbul, Turkey|Basaksehir Cam ve Sakura Sehir Hastanesi, Istanbul, Turkey|Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital, Izmir, Turkey|Kocaeli University Medical Faculty, Kocaeli, Turkey|Mersin University Medical Faculty, Mersin, Turkey|Sakarya University Training and Research Hospital, Sakarya, Turkey|Karadeniz Teknik Universitesi Farabi Hastanesi, Trabzon, Turkey|Communal Medical Enterprise "Likarnya Prydniprovska", Kremenchuk, Poltava Region, Ukraine|Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital", Chernivtsi, Ukraine|Communal non-commercial Enterprise "City Central Clinical Hospital" of Chernivtsi City Council, Chernivtsi, Ukraine|Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council, Dnipro, Ukraine|Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of, Ivano-Frankivsk, Ukraine|Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council", Ivano-Frankivsk, Ukraine|Municipal Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of, Ivano-Frankivsk, Ukraine|Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council, Kharkiv, Ukraine|Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases, Kharkiv, Ukraine|Municipal Nonprofit Enterprise "City Clinic Hospital # 13" of Kharkiv City Council, Kharkiv, Ukraine|Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv, Kyiv, Ukraine|Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company, Kyiv, Ukraine|Municipal non-profit enterprise of Lviv regional council "Lviv regional phthisiopulmonology clinical, Lviv, Ukraine|Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analytical, Lviv, Ukraine|Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4", Lviv, Ukraine|Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional, Poltava, Ukraine|University Hospital of Sumy State University, Sumy, Ukraine|Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council, Tarasove Village, Ukraine|Medical Center of Private Enterprise "Medical center INTERSONO", Uzhhorod, Ukraine|Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1", Vinnytsia, Ukraine|Communal Enterprise "Hospital #1" of Zhytomyr City Council, Zhytomyr, Ukraine
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 2880
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Proportion of participants who have a negative reverse transcription polymerase chain reaction (RT-PCR) result at baseline who develop a symptomatic, RT-PCR or rapid antigen test confirmed SARS-CoV-2 infection.|Percentage of participants who experience adverse events|Efficacy in preventing symptomatic COVID-19 in participants who have a negative RT-PCR result at baseline and are at increased risk of severe COVID-19 illness|Prevention of SARS CoV-2 infection in participants by RT-PCR status at enrolment|Prevention of SARS CoV-2 infection in participants who have a negative RT-PCR result at baseline|Compare the duration of COVID-19 related signs and symptoms in participants who have a negative RT-PCR result at baseline|Compare the severity of COVID-19 related signs and symptoms in participants who have a negative RT-PCR result at baseline|Minimal Concentration (Ctrough) of PF-07321332|All cause mortality in participants who have a negative RT-PCR result at baseline|Viral titers measured via RT-PCR in nasal swabs in participants who have a negative or positive RT-PCR result at baseline|Number of days of hospital and intensive care unit stay in participants with COVID-19 related hospitalization who have a negative RT-PCR result at baseline|Number of COVID-19 related medical visits in participants who have a negative RT-PCR result at baseline
|
NCT02735707
|
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia |
Recruiting |
Phase 3 |
Apr/11/2016 |
Dec/01/2025 |
- Alternative id - U1111-1189-1653|2015-002340-14|602525|16/631|APP1101719|158584
- Interventions - Drug: Ceftriaxone|Drug: Moxifloxacin or Levofloxacin|Drug: Piperacillin-tazobactam|Drug: Ceftaroline|Drug: Amoxicillin-clavulanate|Drug: Standard course macrolide|Drug: Extended course macrolide|Other: No systemic corticosteroid|Drug: Fixed-duration Hydrocortisone|Drug: Shock-dependent hydrocortisone|Drug: Fixed-duration higher dose Hydrocortisone|Other: No antiviral agent for influenza|Drug: Five-days oseltamivir|Drug: Ten-days oseltamivir|Other: No antiviral agent for COVID-19|Drug: Lopinavir / Ritonavir|Drug: Hydroxychloroquine|Drug: Hydroxychloroquine + lopinavir/ritonavir|Drug: Ivermectin|Other: No immune modulation for COVID-19|Drug: Interferon beta-1a|Drug: Anakinra|Drug: Tocilizumab|Drug: Sarilumab|Drug: Local standard venous thromboprophylaxis|Drug: Therapeutic anticoagulation|Drug: Conventional low dose thromboprophylaxis|Drug: Intermediate dose thromboprophylaxis|Drug: Continuation of therapeutic dose anticoagulation|Other: No immunoglobulin|Biological: Convalescent plasma|Biological: Delayed administration of convalescent plasma|Other: No vitamin C|Drug: Vitamin C|Other: No antiplatelet|Drug: Aspirin|Drug: P2Y12 inhibitor|Other: No simvastatin|Drug: Simvastatin|Other: Placebo|Drug: Eritoran|Drug: Apremilast|Procedure: Clinician-preferred mechanical ventilation strategy|Procedure: Protocolised mechanical ventilation strategy|Other: No renin-angiotensin system inhibitor|Drug: Angiotensin converting enzyme inhibitor|Drug: Angiotensin Receptor Blockers|Drug: ARB + DMX-200|Other: No cysteamine|Drug: Cysteamine
- Study type - Interventional
- Study results - No Results Available
- Locations - University of Florida, Jacksonville, Florida, United States|Augusta University, Augusta, Georgia, United States|University of Illinois Health, Chicago, Illinois, United States|Tulane Medical Center, New Orleans, Louisiana, United States|University of Michigan, Ann Arbor, Michigan, United States|Memorial Sloan Kettering Cancer Center, New York, New York, United States|Wake Forest Baptist Health, Winston-Salem, North Carolina, United States|The Ohio State University Wexner Medical Center, Columbus, Ohio, United States|Oregon Health and Science University, Portland, Oregon, United States|University of Pittsburgh Medical Centre, Pittsburgh, Pennsylvania, United States|Brown University - Rhode Island Hospital, Providence, Rhode Island, United States|Canberra Hospital, Canberra, Australian Capital Territory, Australia|Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia|Blacktown Hospital, Blacktown, New South Wales, Australia|Campbelltown Hospital, Campbelltown, New South Wales, Australia|Sutherland Hospital, Caringbah, New South Wales, Australia|Concord Hospital, Concord, New South Wales, Australia|Dubbo Base Hospital, Dubbo, New South Wales, Australia|Northern Beaches Hospital, Frenchs Forest, New South Wales, Australia|Nepean Hospital, Kingswood, New South Wales, Australia|St. George Hospital, Kogarah, New South Wales, Australia|Liverpool Hospital, Liverpool, New South Wales, Australia|John Hunter Hospital, Newcastle, New South Wales, Australia|Orange Health Service, Orange, New South Wales, Australia|St Vincent's Hospital Sydney, Sydney, New South Wales, Australia|Prince of Wales Hospital, Sydney, New South Wales, Australia|Royal Prince Alfred Hospital, Sydney, New South Wales, Australia|Royal North Shore Hospital, Sydney, New South Wales, Australia|Wollongong Hospital, Sydney, New South Wales, Australia|Wagga Wagga Base Hospital, Wagga Wagga, New South Wales, Australia|Westmead Hospital, Westmead, New South Wales, Australia|Royal Darwin Hospital,, Darwin, Northern Territory, Australia|Sunshine Coast University Hospital, Birtinya, Queensland, Australia|The Prince Charles Hospital, Brisbane, Queensland, Australia|Mater Hospital Brisbane, Brisbane, Queensland, Australia|Princess Alexandra Hospital, Brisbane, Queensland, Australia|Caboolture Hospital, Caboolture, Queensland, Australia|Queen Elizabeth II Jubilee Hospital, Coopers Plains, Queensland, Australia|Logan Hospital, Logan, Queensland, Australia|Redcliffe Hospital, Redcliffe, Queensland, Australia|Rockhampton Hospital, Rockhampton, Queensland, Australia|Gold Coast University Hospital, Southport, Queensland, Australia|Toowoomba Hospital, Toowoomba, Queensland, Australia|Townsville Hospital, Townsville, Queensland, Australia|Royal Adelaide Hospital, Adelaide, South Australia, Australia|The Queen Elizabeth Hospital, Adelaide, South Australia, Australia|Lyell McEwin Hospital, Adelaide, South Australia, Australia|Flinders Medical Centre, Bedford Park, South Australia, Australia|Launceston Hospital, Launceston, Tasmania, Australia|Ballarat Base Hospital, Ballarat, Victoria, Australia|Bendigo Hospital, Bendigo, Victoria, Australia|Casey Hospital, Berwick, Victoria, Australia|Box Hill Hospital, Box Hill, Victoria, Australia|Monash Medical Centre, Clayton, Victoria, Australia|Dandenong Hospital, Dandenong, Victoria, Australia|Angliss Hospital, Ferntree Gully, Victoria, Australia|Footscray Hospital, Footscray, Victoria, Australia|University Hosptial Geelong, Geelong, Victoria, Australia|The Alfred Hospital, Melbourne, Victoria, Australia|Royal Melbourne Hospital, Melbourne, Victoria, Australia|St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia|Maroondah Hospital, Ringwood East, Victoria, Australia|Sunshine Hospital, Sunshine, Victoria, Australia|Werribee Mercy Hospital, Werribee, Victoria, Australia|St John of God Hospital Midland, Midland, Western Australia, Australia|St John of God Hospital Murdoch, Murdoch, Western Australia, Australia|Royal Perth Hospital, Perth, Western Australia, Australia|Sir Charles Gairdner Hospital, Perth, Western Australia, Australia|Fiona Stanley Hospital, Perth, Western Australia, Australia|St John of God Subiaco, Subiaco, Western Australia, Australia|AZ Sint-Jan, Brugge, Belgium|CHU de Charleroi - Hôpital Civil Marie Curie, Charleroi, Belgium|Universitair Ziekenhuis Antwerp, Edegem, Belgium|Universitair Ziekenhuis Gent, Gent, Belgium|Foothills Medical Centre, Calgary, Alberta, Canada|Peter Lougheed Centre, Calgary, Alberta, Canada|Rockyview General Hospital, Calgary, Alberta, Canada|South Health Campus, Calgary, Alberta, Canada|Royal Alexandra Hospital, Alberta, Edmonton, Alberta, Canada|University of Alberta Hospital, Edmonton, Alberta, Canada|Surrey Memorial Hospital, Surrey, British Columbia, Canada|St Boniface General Hospital, Winnipeg, Manitoba, Canada|Health Sciences Centre Winnipeg, Winnipeg, Manitoba, Canada|Grace Hospital, Winnipeg, Manitoba, Canada|Dr. Everett Chalmers Regional Hospital, Fredericton, New Brunswick, Canada|The Moncton Hospital, Fredericton, New Brunswick, Canada|The Saint John General Hospital, Fredericton, New Brunswick, Canada|William Osler Health System, Brampton, Ontario, Canada|Brantford General Hospital, Brantford, Ontario, Canada|Hamilton general Hospital, Hamilton, Ontario, Canada|Juravinski Hospital, Hamilton, Ontario, Canada|St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada|Kingston Health Sciences Centre, Kingston, Ontario, Canada|Grand River Hospital, Kitchener, Ontario, Canada|St Mary's General Hospital, Kitchener, Ontario, Canada|The Ottawa Hospital, Ottawa, Ontario, Canada|Niagara Health, Saint Catharines, Ontario, Canada|Thunder Bay General Hospital, Thunder Bay, Ontario, Canada|Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada|St. Michael's Hospital Unity Health Toronto, Toronto, Ontario, Canada|Mount Sinai Hospital, Toronto, Ontario, Canada|Toronto General Hospital, Toronto, Ontario, Canada|Toronto Western Hospital, Toronto, Ontario, Canada|St Joseph's Health Centre, Toronto, Ontario, Canada|CIUSS Chaudieres-Appalaches (Levis), Lévis, Quebec, Canada|Hospital Maisonneuve-Rosemont, Montréal, Quebec, Canada|Hôpital Fleury, Montréal, Quebec, Canada|Centre Hospitalier de l'Universite de Montreal, Montréal, Quebec, Canada|McGill University Health Centre, Montréal, Quebec, Canada|Hopital du Sacre-Coeur de Montreal, Montréal, Quebec, Canada|CHU de Québec - Université Laval, Québec, Quebec, Canada|IUCPQ-UL, Québec, Quebec, Canada|Centre Hospitalier de l'Université de Sherbrooke, Sherbrooke, Quebec, Canada|Regina General Hospital, Saskatoon, Saskatchewan, Canada|Universidad de La Sabana, Chía, Cundinamarca, Colombia|General County Hospital Požega, Požega, Croatia|University Hospital Centre Zagreb, Zagreb, Croatia|University Hospital for Infectious Diseases, Zagreb, Croatia|Charité - Universitätsmedizin Berlin - Infektiologie und Pneumologie, Berlin, Germany|Charité - Universitätsmedizin Berlin - Nephrologie, Berlin, Germany|Vivantes Klinikum Neukölln, Berlin, Germany|Universitätsklinikum Köln, Cologne, Germany|Universitätsklinikum Frankfurt, Frankfurt, Germany|University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany|Medizinische Hochschule Hannover, Hannover, Germany|Universitätsklinikum Jena, Jena, Germany|Universitätsklinikum Leipzig, Leipzig, Germany|Universitäts Klinikum Tübingen, Tübingen, Germany|Universitätsklinikum Würzburg, Würzburg, Germany|Jósa András County Hospital, Nyíregyháza, Hungary|Csolnoky Ferenc Kórház - Veszprem County Hospital, Veszprém, Hungary|Almási Balogh Pál Kórház, Ózd, Hungary|Apollo Main Hospital, Chennai, Tamil Nadu, India|Apollo First Med Hospital, Chennai, Tamil Nadu, India|Apollo Vanagaram Hospital, Chennai, Tamil Nadu, India|Apollo Speciality Hospital - OMR, Chennai, Tamil Nadu, India|Beaumont Hospital, Dublin, Ireland|St. Vincent's University Hospital, Dublin, Ireland|University Hospital Galway, Galway, Ireland|St Marianna University School of Medicine, Kawasaki, Kanagawa, Japan|Yokohama City University Hospital, Yokohama, Kanagawa, Japan|St. Marianna University Yokohama City Seibu Hospital, Yokohama, Kanagawa, Japan|Saiseikai Kumamoto Hospital, Minami, Kumamoto, Japan|Osaka City General Hospital, Osaka, Japan|Nerima Hikarigaoka Hospital, Tokyo, Japan|Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan|Itabashi Chuo Medical Center, Tokyo, Japan|Tokyo bay Urayasu-Ichikawa Medical Center, Tokyo, Japan|Wakayama Medical University, Wakayama, Japan|Chitwan Medical College, Bharatpur, Nepal|Grande International Hospital, Kathmandu, Nepal|Hospital for Advanced Medicine and Surgery (HAMS), Kathmandu, Nepal|Nepal Mediciti, Kathmandu, Nepal|Meander Medisch Centrum, Amersfoort, Netherlands|Jeroen Bosch Ziekenhuis, Den Bosch, Netherlands|Martini Hospital Groningen, Groningen, Netherlands|University Medical Center Groningen, Groningen, Netherlands|Leiden University Medical Center, Leiden, Netherlands|Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands|Radboud University Medical Center, Nijmegen, Netherlands|University Medical Center Utrecht, Utrecht, Netherlands|North Shore Hospital, Auckland, New Zealand|CVICU, Auckland City Hospital, Auckland, New Zealand|DCCM, Auckland City Hospital, Auckland, New Zealand|Middlemore Hospital, Auckland, New Zealand|Christchurch Hospital, Christchurch, New Zealand|Waikato Hospital, Hamilton, New Zealand|Taranaki Base Hospital, New Plymouth, New Zealand|Rotorua Hospital, Rotorua, New Zealand|Tauranga Hospital, Tauranga, New Zealand|Wellington Regional Hospital, Wellington, New Zealand|Whangarei Hospital, Whangarei, New Zealand|Ziauddin University Hospital Clifton Campus, Karachi, Sindh, Pakistan|Abbasi Shaheed Hospital, Karachi, Sindh, Pakistan|National Institute of Cardiovascular Diseases, Karachi, Karachi, Sindh, Pakistan|South City Hospital, Karachi, Karachi, Sindh, Pakistan|Ziauddin University North Nazimabad Campus, Karachi, Sindh, Pakistan|Centro Hospitalar do Medio Tejo, Abrantes, Portugal|Hospital Lusíadas Lisbon, Lisboa, Portugal|Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes", Bucharest, Romania|King Abdulaziz Medical City, Riyadh, Saudi Arabia|Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, Spain|Hospital Universitario Reina Sofia, Córdoba, Spain|Basildon Hospital, Basildon, England, United Kingdom|Basingstoke and North Hampshire Hospital, Basingstoke, England, United Kingdom|Royal United Hospital, Bath, Bath, England, United Kingdom|Queen Elizabeth Hospital Birmingham, Birmingham, England, United Kingdom|Birmingham City Hospital, Birmingham, England, United Kingdom|Blackburn Hospital, Blackburn, England, United Kingdom|Pilgrim's Hospital, Boston, England, United Kingdom|Royal Bournemouth Hospital, Bournemouth, England, United Kingdom|Royal Sussex County Hospital, Brighton, England, United Kingdom|Southmead Hospital, Bristol, England, United Kingdom|Bristol Royal Hospital, Bristol, England, United Kingdom|Queen's Hospital, Burton, Burton on Trent, England, United Kingdom|Royal Papworth Hospital, Cambridge, England, United Kingdom|Addenbrookes Hospital, Cambridge, England, United Kingdom|Cumberland Royal Infirmary, Carlisle, England, United Kingdom|Ashford & St Peters Hospital Trust, Chertsey, England, United Kingdom|Chesterfield Royal Hospital, Chesterfield, England, United Kingdom|Countess of Chester Hospital, Chester, England, United Kingdom|Colchester Hospital, Colchester, England, United Kingdom|University Hospital Coventry, Coventry, England, United Kingdom|North Manchester General Hospital, Crumpsall, England, United Kingdom|Darlington Memorial Hospital, Darlington, England, United Kingdom|Darent Valley Hospital, Dartford, England, United Kingdom|Russells Hall Hospital, Dudley, England, United Kingdom|University Hospital of North Durham, Durham, England, United Kingdom|Royal Devon and Exeter Hospital, Exeter, England, United Kingdom|Frimley Park Hospital, Frimley, England, United Kingdom|Queen Elizabeth Hospital, Gateshead, England, United Kingdom|Medway Maritime Hospital, Gillingham, England, United Kingdom|James Paget Kings Lynn Hospital, Great Yarmouth, England, United Kingdom|Royal Surrey County Hospital, Guildford, England, United Kingdom|Northwick Park Hospital, Harrow, England, United Kingdom|Hereford County Hospital, Hereford, England, United Kingdom|Barnet Hospital, High Barnet, England, United Kingdom|Huddersfield Hospital, Huddersfield, England, United Kingdom|King George Hospital, Ilford, England, United Kingdom|Ipswich Hospital, Ipswich, England, United Kingdom|Kettering Hospital, Kettering, England, United Kingdom|Leeds Teaching Hospitals NHS Trust, Leeds, England, United Kingdom|Leicester Royal Infirmary, Leicester, England, United Kingdom|Glenfield Hospital, Leicester, England, United Kingdom|Lincoln County Hospital, Lincoln, England, United Kingdom|Liverpool Heart and Chest Hospital, Liverpool, England, United Kingdom|Alder Hey Hospital, Liverpool, England, United Kingdom|Royal Liverpool Hospital, Liverpool, England, United Kingdom|University Hospital Aintree, Liverpool, England, United Kingdom|Croydon University Hospital, London, England, United Kingdom|Royal London Hospital, London, England, United Kingdom|Whipps Cross Hospital, London, England, United Kingdom|Newham Hospital, London, England, United Kingdom|St Barts Hosptial, London, England, United Kingdom|North Middlesex Hospital, London, England, United Kingdom|Royal Free Hospital, London, England, United Kingdom|St Thomas' Hospital, London, England, United Kingdom|Guy's Hospital, London, England, United Kingdom|King's College Hospital, London, England, United Kingdom|St George's Hospital, London, England, United Kingdom|Royal Marsden Hospital, London, England, United Kingdom|Ryal Brompton, London, England, United Kingdom|Hammersmith Hospital, London, England, United Kingdom|St Mary's Hospital, London, England, United Kingdom|Charing Cross Hospital, London, England, United Kingdom|Luton and Dunstable University Hospital, Luton, England, United Kingdom|Maidstone Hospital - Maidstone and Tunbridge Wells NHS Trust, Maidstone, England, United Kingdom|Manchester Royal Infirmary, Manchester, England, United Kingdom|The Christie Hospital, Manchester, England, United Kingdom|Wythenshawe Hospital, Manchester, England, United Kingdom|Queen Elizabeth Hospital, Woolwich, Margate, England, United Kingdom|The James Cook University Hospital, Middlesbrough, England, United Kingdom|Milton Keynes University Hospital, Milton Keynes, England, United Kingdom|Royal Victoria Infirmary, Newcastle, Newcastle, England, United Kingdom|Newcastle Freeman Hospital, Newcastle, England, United Kingdom|Northampton General Hospital, Northampton, England, United Kingdom|Norfolk and Norwich University Hospital, Norwich, England, United Kingdom|City Hospital Nottingham, Nottingham, England, United Kingdom|Queen's Medical Centre - Nottingham University Hospitals NHS Trust, Nottingham, England, United Kingdom|George Eliot Hospital, Nuneaton, England, United Kingdom|Royal Oldham Hospital, Oldham, England, United Kingdom|Princess Royal University Hospital, Orpington, England, United Kingdom|John Radcliffe Hospital, Oxford, England, United Kingdom|Derriford Hospital, Plymouth, England, United Kingdom|Poole Hospital NHS Foundation Trust, Poole, England, United Kingdom|Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust, Portsmouth, England, United Kingdom|Whiston Hospital, Prescot, England, United Kingdom|Royal Preston Hospital, Preston, England, United Kingdom|Royal Berkshire Hospital, Reading, England, United Kingdom|Alexandra Hospital, Redditch, Redditch, England, United Kingdom|Queen's Hospital Romford, Romford, England, United Kingdom|Rotherham General Hospital, Rotherham, England, United Kingdom|Salford Royal Hospital, Salford, England, United Kingdom|Salisbury District Hospital, Salisbury, England, United Kingdom|Royal Hallamshire Hospital, Sheffield, England, United Kingdom|Northern General Hospital, Sheffield, England, United Kingdom|Wexham Park Hospital, Slough, England, United Kingdom|South Tyneside District Hospital, South Shields, England, United Kingdom|Southampton General Hospital, Southampton, England, United Kingdom|Stepping Hill Hospital, Stockport, England, United Kingdom|University Hospital of North Tees, Stockton-on-Tees, England, United Kingdom|Royal Stoke University Hospital, Stoke-on-Trent, England, United Kingdom|Sunderland Hospital, Sunderland, England, United Kingdom|King's Mill Hospital, Sutton In Ashfield, England, United Kingdom|Great Western Hospital, Swindon, England, United Kingdom|Western General Hospital, Swindon, England, United Kingdom|Musgrove Park Hospital, Taunton, England, United Kingdom|Torbay and South Devon Hospital, Torquay, England, United Kingdom|Royal Cornwall Hospital, Truro, England, United Kingdom|Tunbridge Wells Hospital - Maidstone and Tunbridge Wells NHS Trust, Tunbridge Wells, England, United Kingdom|Harefield Hospital, Uxbridge, England, United Kingdom|Watford General Hospital, Watford, England, United Kingdom|Southend University Hospital, Westcliff-on-Sea, England, United Kingdom|West Cumberland Hospital, Whitehaven, England, United Kingdom|Royal Albert Edward Infirmary, Wigan, England, United Kingdom|Royal Hampshire Hospital, Winchester, England, United Kingdom|Arrow Park Hospital, Wirral, England, United Kingdom|New Cross Hospital, Wolverhampton, England, United Kingdom|Worcester Royal Hospital, Worcester, England, United Kingdom|York Hospital, York, England, United Kingdom|York Hospital, York, England, United Kingdom|Antrim Area Hospital, Antrim, Northern Ireland, United Kingdom|Royal Victoria Hospital, Belfast, Belfast, Northern Ireland, United Kingdom|Mater Hospital, Belfast, Northern Ireland, United Kingdom|Belfast City Hospital, Belfast, Northern Ireland, United Kingdom|Altnagelvin Hospital, Derry, Northern Ireland, United Kingdom|Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom|Ninewells Hospital, Dundee, Scotland, United Kingdom|Royal Infirmary of Edinburgh, Edinburgh, Scotland, United Kingdom|Glasgow Royal Infirmary, Glasgow, Scotland, United Kingdom|Queen Elizabeth University Hospital, Glasgow, Glasgow, Scotland, United Kingdom|Royal Alexandra Hospital, Glasgow, Paisley, Scotland, United Kingdom|Neville Hall Hospital, Abergavenny, Wales, United Kingdom|Glan Clywd Hospital, Bodelwyddan, Wales, United Kingdom|Princess of Wales Hospital, Bridgend, Wales, United Kingdom|University Hospital of Wales, Cardiff, Wales, United Kingdom|Glangwilli Hospital, Carmarthen, Wales, United Kingdom|Grange University Hospital, Cwmbran, Wales, United Kingdom|Royal Gwent Hospital, Newport, Wales, United Kingdom|Royal Glamorgan Hospital, Pontyclun, Wales, United Kingdom|Morriston Hospital, Swansea, Wales, United Kingdom|Wrexham Maelor Hospital, Wrexham, Wales, United Kingdom
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 10000
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - All-cause mortality|Days alive and not receiving organ support in ICU|ICU Mortality|ICU length of stay|Hospital length of stay|Ventilator free days|Organ failure free days|Health-related Quality of life assessment|Proportion of intubated patients who receive a tracheostomy|Destination at time of hospital discharge|Readmission to the index ICU during the index hospitalization|World Health Organisation 8-point ordinal scale outcome
|
NCT04738045
|
Comparison of Remdesivir Versus Lopinavir/ Ritonavir and Remdesivir Combination in COVID-19 Patients |
Recruiting |
Phase 4 |
Nov/01/2020 |
Apr/01/2021 |
- Alternative id - REC-H-PhBSU-21001
- Interventions - Drug: Remdesivir|Drug: Lopinavir/ Ritonavir and Remdesivir combination
- Study type - Interventional
- Study results - No Results Available
- Locations - Beni-suef University, Banī Suwayf, Egypt
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 90
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group|Monitoring of adverse events.
|
NCT04521400
|
the Investigation Into Beneficial Effects of High-dose Interferon Beta 1-a, Compared to Low-dose Interferon Beta 1-a in Moderate to Severe Covid-19 |
Not yet recruiting |
Phase 2 |
Aug/20/2020 |
Sep/11/2020 |
- Alternative id - Interferon in COVID
- Interventions - Drug: High dose Interferon-beta 1a|Drug: Lopinavir/Ritonavir|Drug: Low dose Interferon-beta 1a
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 100
- Age - 18 Years to 100 Years (Adult, Older Adult)
- Outcome measures - Time to clinical improvement|Mortality|SpO2 Improvement|Incidence of new mechanical ventilation use|Duration of hospitalization|Cumulative incidence of serious adverse events
|
NCT04351724
|
Austrian CoronaVirus Adaptive Clinical Trial (COVID-19) |
Recruiting |
Phase 2|Phase 3 |
Apr/16/2020 |
Mar/31/2022 |
- Alternative id - ACOVACT
- Interventions - Drug: Chloroquine or Hydroxychloroquine|Drug: Lopinavir/Ritonavir|Other: Best standard of care|Drug: Rivaroxaban|Drug: Thromboprophylaxis|Drug: Candesartan|Drug: non-RAS blocking antihypertensives|Drug: Remdesivir|Drug: Asunercept 400mg|Drug: Asunercept 100mg|Drug: Asunercept 25mg|Drug: Pentaglobin
- Study type - Interventional
- Study results - No Results Available
- Locations - Medical University of Innsbruck, Innsbruck, Tirol, Austria|Medical University of Graz, Graz, Austria|Kepler University Hospital, Linz, Austria|Medical University of Vienna, Vienna, Austria|Wilhelminenspital, Vienna, Austria|SMZ Süd Kaiser Franz Josef Spital, Vienna, Austria|KH Hietzing, Vienna, Austria|SMZ Baumgartner Höhe Otto Wagner Spital, Vienna, Austria|SMZ Ost Donauspital, Vienna, Austria
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 500
- Age - 18 Years to 99 Years (Adult, Older Adult)
- Outcome measures - sustained improvement (>48h) of one point on the WHO Scale|Time to improvement on WHO Scale|Mean change in the ranking on an ordinal scale from baseline|time to discharge or a National Early Warning Score (NEWS) ≤2 (maintained for 24h), whichever occurs first|change from baseline in National Early Warning Score (NEWS)|Oxygenation free days|Incidence of new oxygen use during the trial|duration of oxygen use during the trial|Ventilator free days until day 29|Incidence of new mechanical ventilation use during the trial|duration of mechanical ventilation use during the trial|Viral load/viral clearance|Duration of Hospitalization|Mortality|Obesity - mortality|Obesity - duration of hospitalization|Obesity - ICU admission|Obesity - new oxygen use|Drug-drug interactions with lopinavir/ritonavir|Renin Angiotensin System (RAS) fingerprint|SpO2/FiO2 ratio|paO/FiO2 ratio|modified Sequential Organ Failure Assessment|C-reactive protein|Interleukin-6|procalcitonin|IgM Concentrations|IgA Concentrations|differential blood counts
|
NCT04376814
|
Favipiravir Plus Hydroxychloroquine and Lopinavir/Ritonavir Plus Hydroxychloroquine in COVID-19 |
Completed |
Not Applicable |
Mar/29/2020 |
May/25/2020 |
- Alternative id - IR.BMSU.REC.1399.017
- Interventions - Drug: Favipiravir|Drug: Hydroxychloroquine|Drug: Lopinavir / Ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations - Mohammad Sadegh Bagheri Baghdasht, Tehran, Iran, Islamic Republic of
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 40
- Age - 16 Years to 100 Years (Child, Adult, Older Adult)
- Outcome measures - Mortality|long of hospitalization|Laboratory Treatment Response (Blood cell count)|Laboratory Treatment Response (CRP )|Dyspnea|Oxygen saturation without supplemental oxygen.|Oxygen therapy
|
NCT04466241
|
Combination Therapies to Reduce Carriage of SARS-Cov-2 and Improve Outcome of COVID-19 in Ivory Coast: a Phase Randomized IIb Trial |
Recruiting |
Phase 2|Phase 3 |
Nov/27/2020 |
Mar/26/2021 |
- Alternative id - ANRS COV01 INTENSE COV
- Interventions - Drug: Lopinavir/Ritonavir 200 MG-50 MG Oral Tablet|Drug: Telmisartan 40Mg Oral Tablet|Drug: Atorvastatin 20 Mg Oral Tablet
- Study type - Interventional
- Study results - No Results Available
- Locations - Service des Maladies Infectieuses et Tropicales, Centre Hospitalier et Universitaire (CHU) Treichville, Abidjan, Côte D'Ivoire|Centre de Traitement des Maladies Infectieuses (CTMI), CHU de Yopougon, Abidjan, Côte D'Ivoire
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 294
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Proportion of patients with undetectable nasopharyngeal swab SARS-CoV-2 PCR and C-reactive protein (CRP) < 27 mg/L at Day 11|Proportion of patients with clinical improvement on the 7-point ordinal scale at Day 11 and Day 28|Kinetics of SARS-CoV-2 viral load|Death rate at Day 11 and Day 28|All causes of death and Acute respiratory distress syndrome (ARDS) at Day 28|Time to hospital discharge|Duration of oxygen supplementation|Prevalence of grade III or IV adverse events|Residual concentration of lopinavir, telmisartan and atorvastatin|Evolution of inflammatory and immunological markers (CRP, fibrinogen, ferritin, d-dimer, dosing of IgG, IgA, IgM; TCD4, CD8, B lymphocytes, NK lymphocytes; naïve/memory T lymphocytes)|Evolution of endothelial activation markers (VEGF and soluble VEGF receptor,VE-cadherin, PECAM/CD31, CD42 and angiopoietin-2)|Proportion of patients with good results according to HIV status|Number of contact cases infected by COVID-19 at Day 28
|
NCT05011513
|
Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR). |
Active, not recruiting |
Phase 2|Phase 3 |
Aug/25/2021 |
Apr/25/2022 |
- Alternative id - C4671002|2021-002857-28|EPIC-SR
- Interventions - Drug: PF-07321332|Drug: Ritonavir|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Cahaba Research Inc, Birmingham, Alabama, United States|Cahaba Research, Inc., Birmingham, Alabama, United States|Cahaba Research, Inc., Pelham, Alabama, United States|The Institute for Liver Health dba Arizona Clinical Trials, Mesa, Arizona, United States|The Institute for Liver Health dba Arizona Clinical Trials, Tucson, Arizona, United States|KLR Business Group, Inc. dba Arkansas Clinical Research, Little Rock, Arkansas, United States|Hope Clinical Research, Canoga Park, California, United States|Lightship, El Segundo, California, United States|Ascada Research, Fullerton, California, United States|eStudySite, La Mesa, California, United States|Atella Clinical Research LLC., La Palma, California, United States|Ark Clinical Research, Long Beach, California, United States|American Institute of Research, Los Angeles, California, United States|Providence Clinical Research, North Hollywood, California, United States|FOMAT Medical Research, Oxnard, California, United States|Stanford University, Palo Alto, California, United States|Benchmark Research, Sacramento, California, United States|Optimus Medical Group, San Francisco, California, United States|South Bay Clinical Research Institute, Torrance, California, United States|Hope Clinical Research (COVID Satellite Site), West Hills, California, United States|Future Innovative Treatments, LLC, Colorado Springs, Colorado, United States|BRB Health Group DBA Broward Research Center, Aventura, Florida, United States|Xera Med Research, Boca Raton, Florida, United States|Synergy Healthcare, Bradenton, Florida, United States|MOORE Clinical Research, Inc., Brandon, Florida, United States|Innovative Research of West Florida, Clearwater, Florida, United States|Herco Medical and Research Center Inc, Coral Gables, Florida, United States|Advance Clinical Research Group, Cutler Bay, Florida, United States|Beautiful Minds Clinical Research Center, Cutler Bay, Florida, United States|Midland Florida Clinical Research Center, LLC, DeLand, Florida, United States|Unlimited Medical Research Group, LLC, Hialeah Gardens, Florida, United States|Qway Research, LLC, Hialeah, Florida, United States|Eastern Research Inc, Hialeah, Florida, United States|Inpatient Research Clinic, Hialeah, Florida, United States|Doral Medical Research, LLC, Hialeah, Florida, United States|Advanced Pulmonary Research Institute, Loxahatchee Groves, Florida, United States|Asclepes Research Centers, Lutz, Florida, United States|Pro-Care Research Center, Corp., Miami Gardens, Florida, United States|Lakes Research, LLC., Miami Lakes, Florida, United States|Savin Medical Group, LLC, Miami Lakes, Florida, United States|Angels Clinical Research Institute, Miami, Florida, United States|Nova Life Med Spa, Miami, Florida, United States|LCC Medical Research Institute, LLC, Miami, Florida, United States|Premium Medical Research Corp, Miami, Florida, United States|Global Health Clinical Trials Corp, Miami, Florida, United States|South Florida Research Center, Inc., Miami, Florida, United States|Suncoast Research Group, LLC, Miami, Florida, United States|University of Miami Health System, Miami, Florida, United States|I.V.A.M. Clinical & Investigational Center, LLC, Miami, Florida, United States|Entrust Clinical Research, Miami, Florida, United States|Medical Research of Westchester Inc, Miami, Florida, United States|C'A Research, Miami, Florida, United States|ProLive Medical Research, Corp., Miami, Florida, United States|Reed Medical Research, Miami, Florida, United States|Kendall South Medical Center, Inc., Miami, Florida, United States|Clinical Site Partners, Inc d/b/a CSP Miami, Miami, Florida, United States|Coral Research Clinic Corp, Miami, Florida, United States|Omega Research Orlando, LLC, Orlando, Florida, United States|NAPA Research LLC, Pompano Beach, Florida, United States|CDC Research Institute, Port Saint Lucie, Florida, United States|GCP, Global Clinical Professionals, Saint Petersburg, Florida, United States|Accel Research Sites - St. Petersburg Clinical Research Unit, Saint Petersburg, Florida, United States|Professional Urgent Care Services, Saint Petersburg, Florida, United States|USPA Advance Concept Medical Research Group LLC, South Miami, Florida, United States|Asclepes Research Centers, Spring Hill, Florida, United States|Sunrise Research Institute, Sunrise, Florida, United States|Tampa General Hospital, Tampa, Florida, United States|Santos Research Center, CORP, Tampa, Florida, United States|Palm Beach Research Center, West Palm Beach, Florida, United States|Clinical Site Partners, Inc. dba CSP Orlando, Winter Park, Florida, United States|Emory Clinic Investigational Drug Services, Atlanta, Georgia, United States|The Hope Clinic at Emory University - Annex, Decatur, Georgia, United States|The Hope Clinic at Emory University, Decatur, Georgia, United States|The Hope Clinic Investigational Drug Services - Satellite Pharmacy, Decatur, Georgia, United States|The South Bend Clinic Center for Research, South Bend, Indiana, United States|Accellacare, Ames, Iowa, United States|McFarland Clinic, PC, Ames, Iowa, United States|WKB Family Medicine Associates, Bossier City, Louisiana, United States|New Orleans Sinus Center (COVID-19 Testing), Marrero, Louisiana, United States|Tandem Clinical Research GI, LLC, Marrero, Louisiana, United States|Southern Clinical Research Associates, LLC, Metairie, Louisiana, United States|MedPharmics LLC, Metairie, Louisiana, United States|Willis-Knighton Health System, Shreveport, Louisiana, United States|Michigan Center of Medical Research, Farmington Hills, Michigan, United States|Jackson Medical Mall, Jackson, Mississippi, United States|Lakeland Pharmacy, Branson W., Missouri, United States|CVS, Springfield, Missouri, United States|Mercury Street Medical Group, PLLC, Butte, Montana, United States|Meridian Clinical Research, LLC, Grand Island, Nebraska, United States|Quality Clinical Research Inc, Omaha, Nebraska, United States|Quality Clinical Research, Omaha, Nebraska, United States|Walmart, Las Vegas, Nevada, United States|Excel Clinical Research, Las Vegas, Nevada, United States|Walgreens, Las Vegas, Nevada, United States|AXCES Research Group, Santa Fe, New Mexico, United States|Meridian Clinical Research, LLC, Endwell, New York, United States|NYC Health + Hospitals/Harlem, New York, New York, United States|Monroe Biomedical Research, Monroe, North Carolina, United States|Accellacare, Wilmington, North Carolina, United States|Innovo Research: Wilmington Health, Wilmington, North Carolina, United States|Rhode Island Hospital, Providence, Rhode Island, United States|The Miriam Hospital, Providence, Rhode Island, United States|Avera McKennan Hospital & University Health Center, Sioux Falls, South Dakota, United States|Avera Research Institute, Sioux Falls, South Dakota, United States|Premier Medical Group, Clarksville, Tennessee, United States|PharmaTex Research, LLC, Amarillo, Texas, United States|ARC Clinical Research at William Cannon, Austin, Texas, United States|St Hope Foundation, Bellaire, Texas, United States|Conroe Willis Medical Research, Conroe, Texas, United States|South Texas Clinical Research, Corpus Christi, Texas, United States|Urgent Care Clinical Trials at City Doc McKinney, Dallas, Texas, United States|SignatureCare Emergency Center, Houston, Texas, United States|Trio Clinical Trials, LLC, Houston, Texas, United States|C & R Research Services USA, Houston, Texas, United States|Houston Methodist Hospital, Houston, Texas, United States|Next Level Urgent Care, Houston, Texas, United States|SMS Clinical Research, LLC, Mesquite, Texas, United States|LinQ Research, LLC, Pearland, Texas, United States|Epic Medical Research, Red Oak, Texas, United States|Sun Research Institute, San Antonio, Texas, United States|Endeavor Clinical Trials, LLC, San Antonio, Texas, United States|BFHC Research, San Antonio, Texas, United States|Tranquility Research, Webster, Texas, United States|University of Utah Medical Center, Salt Lake City, Utah, United States|TMPG Clinical Research, Newport News, Virginia, United States|TPMG Clinical Research, Newport News, Virginia, United States|Centro Médico Viamonte, Caba, Buenos Aires, Argentina|DIM Clinica Privada, Ramos Mejia, Buenos Aires, Argentina|Instituto de Investigaciones Clinicas Zarate, Zarate, Buenos Aires, Argentina|Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos), Rosario, Santa FE, Argentina|Sanatorio Britanico S.A., Rosario, Santa FE, Argentina|Instituto CAICI, Rosario, Santa FE, Argentina|Hospital de Clinicas Presidente Nicolas Avellaneda, San Miguel de Tucuman, Tucuman, Argentina|Clinica Mayo Urgencias Medicas Cruz Blanca SRL, San Miguel de Tucuman, Tucuman, Argentina|Hospital Privado Centro Médico de Córdoba, Córdoba, Argentina|Fundação de Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, Amazonas, Brazil|Chronos Pesquisa Clinica, Brasilia, Distrito Federal, Brazil|AMB3 Serviços Médicos Ltda, Cuiabá, MATO Grosso, Brazil|Hospital Luxemburgo - Associacao Mario Penna, Belo Horizonte, MG, Brazil|School of Medicine Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil|Hospital Agamenon Magalhaes, Recife, Pernambuco, Brazil|Centro de Estudos e Pesquisas em Moléstias Infecciosas, Natal, RIO Grande DO Norte, Brazil|Hospital De Clinicas De Porto Alegre, Porto Alegre, RIO Grande DO SUL, Brazil|IBPClin - Instituto Brasil de Pesquisa Clínica, Rio de Janeiro, RJ, Brazil|Instituto Nacional de Infectologia Evandro Chagas - INI/FIOCRUZ, Rio de Janeiro, RJ, Brazil|CECOR - Centro Oncológico de Roraima, Boa Vista, Roraima/rr, Brazil|Hospital Regional Hans Dieter Schmidt (HRHDS), Joinville, Santa Catarina/sc, Brazil|Scentryphar - Pesquisa ClInica, Campinas, SAO Paulo, Brazil|Centro de Estudos Clinicos do Interior Paulista (CECIP), Jau, SAO Paulo, Brazil|Hospital Dia do Pulmao, Blumenau, SC, Brazil|Hospital e Maternidade Celso Pierro - PUC Campinas / Sociedade Campineira de Educação e Instruçã, Campinas, SP, Brazil|Pesquisare Saude S/S Ltda, Santo André, SP, Brazil|Hospital Alemão Oswaldo Cruz, São Paulo, SP, Brazil|Unidade Referenciada Oswaldo Cruz Vergueiro, São Paulo, SP, Brazil|Hospital Heliópolis, São Paulo, SP, Brazil|Instituto D'Or de Pesquisa e Ensino / Hospital São Luiz Jabaquara, São Paulo, SP, Brazil|Scentryphar - Pesquisa ClInica, Campinas, SÃO Paulo, Brazil|Associação Evangélica de Campinas - Hospital Samaritano, Campinas, SÃO Paulo, Brazil|Instituto de Pesquisa Clínica de Campinas, Campinas, SÃO Paulo, Brazil|Centro de Referência e Treinamento DST/AIDS, Sao Paulo, SÃO Paulo, Brazil|Clinica de Alergia Martti Antila, Sorocaba, SÃO Paulo, Brazil|CEMEC - Centro Multidisciplinar de Estudos Clínicos, São Bernardo do Campo, SÃO Paulo, Brazil|CPCLIN - Centro de Pesquisas Clinicas Ltda, São Paulo, Brazil|Instituto de Infectologia Emilio Ribas, São Paulo, Brazil|Conjunto Hospitalar do Mandaqui, São Paulo, Brazil|Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD, Burgas, Bulgaria|MHAT St. Ekaterina, Dimitrovgrad EOOD, Dimitrovgrad, Bulgaria|"Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd, Haskovo, Bulgaria|MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD, Kozloduy, Bulgaria|Diagnostic-Consultative Center I Lom EOOD, Lom, Bulgaria|Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD, Lom, Bulgaria|Medical centre Leo Clinic EOOD, Lovech, Bulgaria|MHAT Heart and Brain EAD, Pleven, Bulgaria|UMHAT Sveta Marina - Pleven, Pleven, Bulgaria|DCC Sveti Georgi EOOD, Plovdiv, Bulgaria|MHAT "St. Panteleimon "- Plovdiv, Plovdiv, Bulgaria|Multi-Profile Hospital for Active treatment ''Plovdiv''AD, Plovdiv, Bulgaria|Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD, Razgrad, Bulgaria|"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -, Ruse, Bulgaria|UMHAT Medica Ruse OOD, Ruse, Bulgaria|Multiprofile Hospital for Active Treatment - Samokov EOOD, Samokov, Bulgaria|Medical Center-1-Sevlievo EOOD, Sevlievo, Bulgaria|Multiprofile Hospital For Active Treatment Shumen AD, Shumen, Bulgaria|Multiprofile hospital for active treatment - Sliven to Military Medical Academy, Sliven, Bulgaria|MHAT "Dr. Ivan Seliminski" AD, Sliven, Sliven, Bulgaria|Diagnostic-Consultative Center XXII- Sofia ЕООD, Sofia, Bulgaria|University First MHAT "St. Yoan Krastitel"-Sofia EAD, Sofia, Bulgaria|Diagnostic Consultative Center 18 - Sofia EOOD, Sofia, Bulgaria|MHAT "St. Sofia" EOOD, Sofia, Bulgaria|Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD, Stara Zagora, Bulgaria|Multiprofile Hospital for Active Treatment Targovishte AD, Targovishte, Bulgaria|Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD, Tsarevo, Bulgaria|Medical center Leo Clinic EOOD, Varna, Bulgaria|Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD, Vratsa, Bulgaria|Fundacion Centro de Investigacion Clinica CIC, Medellin, Antioquia, Colombia|Clinica de la Costa LTDA., Barranquilla, Atlantico, Colombia|Hospital Universidad Del Norte, Soledad, Atlantico, Colombia|IPS Medicos Internistas de Caldas, Manizales, Caldas, Colombia|Caimed S.A.S., Yopal, Casanare, Colombia|Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S, Bogota, Cundinamarca, Colombia|Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia, Bogotá D.C., Cundinamarca, Colombia|Bluecare Salud S A S, Bogota, D.c., Colombia|Fundacion Cardiomet CEQUIN, Armenia, Quindio, Colombia|Klinika infekcnich nemoci, Hradec Kralove, Czechia|MEDITRIAL s.r.o., Jindrichuv Hradec III, Czechia|Zdraví-Fit, s.r.o., Protivín, Czechia|Nemocnice Slany, Slany, Czechia|Trial Pharma Kft., Bekescsaba, Hungary|Semmelweis University Varosmajori Sziv Es Ergyogyaszati Klinika, Budapest, Hungary|Varosmajori Sziv- es Ergyogyaszati Klinika, Budapest, Hungary|Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika, Debrecen, Hungary|Agria-Study Kft., Eger, Hungary|Trial Pharma Kft., Gyula, Hungary|Medifarma-98 Kft., Nyiregyhaza, Hungary|Szent Borbala Korhaz, Tatabanya, Hungary|Fujita Health University Hospital, Toyoake-City, Aichi, Japan|Chiba Aoba Municipal Hospital, Chuo-ku, Chiba, Japan|International University of Health and Welfare Narita Hospital, Narita, Chiba, Japan|National Hokkaido Medical Center, Sapporo, Hokkaido, Japan|Rakuwakai Otowa Hospital, Kyoto-shi, Kyoto, Japan|Rinku General Medical Center, Izumisano, Osaka, Japan|Tokyo Medical University Hachioji Medical Center, Hachioji, Tokyo, Japan|Tokyo Shinagawa Hospital, Shinagawa-ku, Tokyo, Japan|National Center for Global Health and Medicine, Shinjuku City, Tokyo, Japan|Sekino Hospital, Toshimaku, Tokyo, Japan|Kyushu Medical Center, Fukuoka, Japan|Chonnam National University Hospital, Gwangju-si, Kwangju-kwangy?kshi, Korea, Republic of|Pusan National University Hospital, Busan, Korea, Republic of|Kyungpook National University Chilgok Hospital, Daegu, Korea, Republic of|Chonnam National University Bitgoeul Hospital, Gwangju, Korea, Republic of|Incheon Medical Center, Incheon, Korea, Republic of|Boramae Medical Center, Seoul, Korea, Republic of|Seoul Medical Center, Seoul, Korea, Republic of|Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan, Malaysia|Hospital Taiping, Taiping, Perak, Malaysia|Hospital Seberang Jaya, Perai, Pulau Pinang, Malaysia|Hospital Miri, Miri, Sarawak, Malaysia|Klinik Kesihatan Kuang, Rawang, Selangor, Malaysia|InfectoLab Consultorios de Especialidad en Infectologia, Tijuana, BAJA California, Mexico|Clinical Research Institute Saltillo S.A. de C.V., Saltillo, Coahuila, Mexico|Arke SMO S.A. de C.V, Veracruz, COL. Ignacio Zaragoza, Mexico|Centro de Investigacion Clinica Del Pacifico SA de CV, Acapulco de Juarez, Guerrero, Mexico|Asociación Mexicana para la Investigación Clínica A.C., Pachuca de Soto, Hidalgo, Mexico|Instituto Jalisciense de Metabolismo, S.C., Guadalajara, Jalisco, Mexico|JM Research, Cuernavaca, Morelos, Mexico|Christus - Latam Hub Center of Excellence and Innovation Center S.C., Monterrey, Nuevo LEON, Mexico|Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Nuevo LEON, Mexico|Eukarya Pharmasite S.C., Monterrey, Nuevo LEON, Mexico|Oaxaca Site Management Organization, Oaxaca de Juarez, Oaxaca, Mexico|Hospital General de Culiacán "Bernardo J. Gastélum", Culíacan, Sinaloa, Mexico|Köhler & Milstein Research, Merida, Yucatan, Mexico|Eme Red Hospitalaria, Mérida, Yucatán, Mexico|Hospital Cardiologica Aguascalientes, Aguascalientes, Mexico|Instituto de Investigaciones Clínicas para la Salud, Durango, Mexico|FAICIC Clinical Research, Veracruz, Mexico|Sociedad de Metabolismo y Corazon S.C., Veracruz, Mexico|KLIMED Marek Klimkiewicz, Bialystok, Poland|Krakowskie Centrum Medyczne, Krakow, Poland|Przychodnia Valeo Medical, Lodz, Poland|IRMED Ośrodek Badań Klinicznych, Piotrkow Trybunalski, Poland|Tomasz Blicharski Lubelskie Centrum Diagnostyczne, Swidnik, Poland|WIP Warsaw IBD Point Profesor Kierkus, Warszawa, Poland|Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska, Wroclaw, Poland|Ponce Medical School Foundation, Inc. CAIMED Center, Ponce, Puerto Rico|Clinical Research Management Group Inc, Ponce, Puerto Rico|Advance Medical Research Center, San Juan, Puerto Rico|MERC Welkom, Welkom, FREE State, South Africa|Worthwhile Clinical Trials, Benoni, Gauteng, South Africa|REIMED Vosloorus, Boksburg, Gauteng, South Africa|Peermed CTC (Pty) Ltd T/A MERC Kempton, Kempton Park, Gauteng, South Africa|Midrand Medical Centre, Midrand, Gauteng, South Africa|Global Clinical Trials, Pretoria, Gauteng, South Africa|The Aurum Institute: Pretoria Clinical Research Centre, Pretoria, Gauteng, South Africa|Botho ke Bontle Health Services, Pretoria, Gauteng, South Africa|Emmed Research, Pretoria, Gauteng, South Africa|Into Research, Pretoria, Gauteng, South Africa|Clinical Trial Systems (Pty) Ltd, Pretoria, Gauteng, South Africa|Sandton Medical Clinic, Sandton, Gauteng, South Africa|FCRN Clinical Trial Centre, Vereeniging, Gauteng, South Africa|Dr PJ Sebastian Clinical Research Centre, Durban, Kwa-zulu Natal, South Africa|Synapta Clinical Research Center, Durban, Kwazulu Natal, South Africa|Ahmed Al-Kadi Private Hospital, Mayville, Durban, Kwazulu-natal, South Africa|Limpopo Clinical Research Initiative, Thabazimbi, Limpopo, South Africa|NHC Thohoyandou CRS, Thohoyandou, Limpopo, South Africa|MERC Middelburg, Middelburg, Mpumalanga, South Africa|TASK Eden, George, Western CAPE, South Africa|Be Part Research Pty (Ltd), Paarl, Western CAPE, South Africa|Clinical Projects Research, Worcester, Western CAPE, South Africa|Dr JM Engelbrecht Trial Site, Somerset West, South Africa|Eba Centelles, Centelles, Barcelona [barcelona], Spain|Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain|CAP Vicenç Papaceit, La Roca del Valles, Barcelona, Spain|CAP La Mina, Sant Adria de Besos, Barcelona, Spain|Hospital Clinico San Carlos, Madrid, Madrid, Comunidad DE, Spain|Hospital Alvaro Cunqueiro, Vigo, Pontevedra, Spain|IMED Valencia, Burjassot, Valencia, Spain|Complexo Hospitalario Universitario da Coruna, A Coruna, Spain|Complexo Hospitalario Universitario da Coruna, A Coruña, Spain|Hospital Universitario Virgen de las Nieves, Granada, Spain|Hospital Universitario de la Paz, Madrid, Spain|Hospital Universitario de Salamanca, Salamanca, Spain|Hospital Universitario Virgen de Valme, Sevilla, Spain|Far Eastern Memorial Hospital, New Taipei City, Taiwan|China Medical University Hospital, Taichung City, Taiwan|Taichung Veterans General Hospital, Taichung, Taiwan|National Taiwan University Hospital, Taipei, Taiwan|Siriraj Hospital, Mahidol University, BangkokNoi, Bangkok, Thailand|Riverside Bangkok Hotel, Bangplud, Bangkok, Thailand|Bangkok Centre Hotel, Bangrak, Bangkok, Thailand|Chula Filed hospital, Chulalongkorn University Sport center (Chantanayingyong Gymnasium),, Pathum Wan District,, Bangkok, Thailand|Thai Red Cross Emerging Infectious Diseases (EDI) Clinic, Pathumwan,, Bangkok, Thailand|The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),, Pathumwan, Bangkok, Thailand|Baiyoke Suite Hotel, Ratchathewi, Bangkok, Thailand|Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,, Hat Yai, Songkhla, Thailand|Khon Kaen Univerisity Field Hospital, Student Dormitory 26, Khon Kaen University, Khon Kaen, Thailand|Srinagarind Hospital, Khon Kaen, Thailand|Cukurova University Medical Faculty, Balcali, Adana, Turkey|Ankara University Medical Faculty, Ibni-Sina Hospital, Ankara, Turkey|Hacettepe University Medical Faculty Hospital, Ankara, Turkey|Akdeniz Universitesi Hastanesi, Antalya, Turkey|Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi, Gaziantep, Turkey|Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi, Istanbul, Turkey|Istanbul University Istanbul Medical Faculty, Istanbul, Turkey|Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty, Istanbul, Turkey|Medipol Mega University Hospital, Istanbul, Turkey|Acibadem University Atakent Hospital, Istanbul, Turkey|Basaksehir Cam ve Sakura Sehir Hastanesi, Istanbul, Turkey|Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital, Izmir, Turkey|Kocaeli University Medical Faculty, Kocaeli, Turkey|Mersin University Medical Faculty, Mersin, Turkey|Sakarya University Training and Research Hospital, Sakarya, Turkey|Karadeniz Teknik Universitesi Farabi Hastanesi, Trabzon, Turkey|Communal Medical Enterprise "Likarnya Prydniprovska", Kremenchuk, Poltava Region, Ukraine|Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital", Chernivtsi, Ukraine|Communal non-commercial Enterprise "City Clinical Hospital №3" of Chernivtsi City Council, Chernivtsi, Ukraine|Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council, Dnipro, Ukraine|Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of, Ivano-Frankivsk, Ukraine|Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council", Ivano-Frankivsk, Ukraine|Municipal Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of, Ivano-Frankivsk, Ukraine|Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council, Kharkiv, Ukraine|Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases, Kharkiv, Ukraine|Municipal Nonprofit Enterprise "City Clinic Hospital # 13" of Kharkiv City Council, Kharkiv, Ukraine|Municipal Non-profit Enterprise "Oleksandrivska Kyiv City Clinical Hospital" Of Executive Body Of, Kyiv, Ukraine|Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv, Kyiv, Ukraine|Kyiv Railway Clinical Hospital No.2 of Branch "Health Center of the Public Joint Stock Company, Kyiv, Ukraine|Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company, Kyiv, Ukraine|Municipal non-profit enterprise of Lviv regional council "Lviv regional phthisiopulmonology clinical, Lviv, Ukraine|Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4", Lviv, Ukraine|Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional, Poltava, Ukraine|Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council, Tarasove Village, Ukraine|Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1", Vinnytsia, Ukraine|Communal Enterprise "Hospital #1" of Zhytomyr City Council, Zhytomyr, Ukraine
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 1150
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Time to Sustained Alleviation of All Targeted COVID-19 Signs/Symptoms|Percentage of Participants Who Experience Adverse Events (AEs)|Percentage of Participants Who Experience an AE(s) or Serious Adverse Events (SAEs) that Leads to Study Discontinuation|Proportion of Participants With Severe Signs/Symptoms Attributed to COVID-19|Time to Sustained Resolution of All Targeted COVID-19 Signs/Symptoms|Duration of Each Targeted COVID-19 Sign/Symptom|Proportion of Participants Progressing to a Worsening Status In 1 or More COVID-19 Signs/Symptoms|Proportion of Participants With a Resting Peripheral Oxygen Saturation ≥95%|Number of COVID-19 Related Medical Visits|Number of Days in Hospital and Intensive Care Unit (ICU) Stay in Participants With COVID-19 Related Hospitalization|Proportion of Participants With COVID-19 Related Hospitalization or Death From Any Cause|Proportion of Participants With Death (all cause)|Minimal Concentration (Ctrough) of PF-07321332|Viral Titers Measured Via Reverse Transcription Polymerase Chain Reaction (RT-PCR) in Nasal Swabs
|
NCT04459286
|
The Nitazoxanide Plus Atazanavir for COVID-19 Study |
Terminated |
Phase 2 |
Oct/09/2020 |
May/02/2021 |
- Alternative id - NACOVID
- Interventions - Drug: Nitazoxanide and atazanavir/ritonavir|Other: Standard of Care
- Study type - Interventional
- Study results - No Results Available
- Locations - Olabisi Onabanjo University Teaching Hospital, Sagamu, Ogun State, Nigeria|Infectious Disease Hospital, Olodo, Ibadan, Oyo State, Nigeria
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 57
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Time to clinical improvement|Time to SARS-CoV-2 negativity|Difference in SARS-CoV-2 AUC|Time to symptoms resolution|Clinical status as assessed with the seven-category ordinal scale on days 7 and 14|Duration of hospitalization in survivors|Day 28 mortality|Time from treatment initiation to death|Proportion with viral RNA detection over time
|
NCT04365582
|
OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome |
Withdrawn |
Phase 3 |
May/07/2020 |
Apr/19/2021 |
- Alternative id - OUTCOV
- Interventions - Drug: Azithromycin|Drug: Hydroxychloroquine|Drug: Lopinavir 200Mg/Ritonavir 50Mg Tab
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 0
- Age - 50 Years and older (Adult, Older Adult)
- Outcome measures - Hospital admission|Effect of treatment on Death at D20|Effect of treatment on Death at D60|Effect of treatment on Death due to COVID at D20|Effect of treatment on Death due to COVID at D60|Effect of treatment on need for ICU stay at D20|Effect of treatment on need for ICU stay at D60|Effect of treatment on duration of ICU stay at D20|Effect of treatment on duration of ICU stay at D60|Effect of treatment on need of mechanical ventilation at D20|Effect of treatment on need of mechanical ventilation at D60|Effect of treatment on duration of mechanical ventilation at D20|Effect of treatment on duration of mechanical ventilation at D60|Effect of treatment on time to hospitalization at D20|Effect of treatment on time to hospitalization at D60|Effect of treatment on Duration of Hospital stay et D20|Effect of treatment on Duration of Hospital stay et D60|Effect of treatment on Duration of symptoms at D20|Effect of treatment on Duration of symptoms at D60|Incidence of Treatment-Emergent Adverse Events
|
NCT04331470
|
Evaluation of Efficacy of Levamisole and Formoterol+Budesonide in Treatment of COVID-19 |
Recruiting |
Phase 2|Phase 3 |
Apr/04/2020 |
May/20/2020 |
- Alternative id - 97548
- Interventions - Drug: Levamisole Pill + Budesonide+Formoterol inhaler|Drug: Lopinavir/Ritonavir + hydoxychloroquine
- Study type - Interventional
- Study results - No Results Available
- Locations - Vali-Asr Hospital, Fasa, Fars, Iran, Islamic Republic of
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 30
- Age - 15 Years to 100 Years (Child, Adult, Older Adult)
- Outcome measures - Clear chest CT-scan|PCR test|Physical statues of patient
|
NCT04295551
|
Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe) |
Unknown status |
Not Applicable |
Mar/14/2020 |
Apr/14/2021 |
- Alternative id - QF-XYP1990-1
- Interventions - Drug: Lopinavir / ritonavir tablets combined with Xiyanping injection|Drug: Lopinavir/ritonavir treatment
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 80
- Age - 18 Years to 100 Years (Adult, Older Adult)
- Outcome measures - Clinical recovery time
|
NCT04350671
|
Interferon Beta 1a in Hospitalized COVID-19 Patients |
Enrolling by invitation |
Phase 4 |
Apr/15/2020 |
Apr/24/2020 |
- Alternative id - Interferon Beta 1a in COVID-19
- Interventions - Drug: Interferon Beta-1A|Drug: Lopinavir / Ritonavir|Drug: Single Dose of Hydroxychloroquine
- Study type - Interventional
- Study results - No Results Available
- Locations - Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services, Tehran, Iran, Islamic Republic of
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 40
- Age - 50 Years and older (Adult, Older Adult)
- Outcome measures - Time to clinical improvement|Mortality|SpO2 Improvement|Incidence of new mechanical ventilation use|Duration of hospitalization|Cumulative incidence of serious adverse events
|
NCT04779047
|
Comparative Therapeutic Efficacy and Safety of Different Antiviral and Anti Inflammatory Drugs in COVID-19 Patients. |
Recruiting |
Phase 4 |
Oct/01/2020 |
Apr/05/2021 |
- Alternative id - REC-H-PhBSU-21011
- Interventions - Drug: Remdesivir|Drug: Hydroxychloroquine|Drug: Tocilizumab|Drug: Lopinavir/ Ritonavir|Drug: Ivermectin
- Study type - Interventional
- Study results - No Results Available
- Locations - Beni-suef University, Banī Suwayf, Egypt
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 150
- Age - 18 Years to 88 Years (Adult, Older Adult)
- Outcome measures - Percentage of clinical cure in each arm
|
NCT04315948
|
Trial of Treatments for COVID-19 in Hospitalized Adults |
Recruiting |
Phase 3 |
Mar/22/2020 |
Mar/01/2023 |
- Alternative id - C20-15|101015736
- Interventions - Drug: Remdesivir|Drug: Lopinavir/ritonavir|Drug: Interferon Beta-1A|Drug: Hydroxychloroquine|Other: Standard of care|Drug: AZD7442|Other: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Medizinische Universität Innsbruck, Innsbruck, Austria|Kepler Universitätsklinikum Linz, Linz, Austria|Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität, Salzburg, Austria|Hôpital Erasme - Cliniques universitaires de Bruxelles, Brussels, Belgium|Hôpital Saint Luc, Brussels, Belgium|CHU Brugmann, Brussels, Belgium|Hôpital La Citadelle, Liège, Belgium|Pôle Hospitalier Jolimont / site de Mons-Warquignies, Mons, Belgium|Fakultní nemocnice u sv. Anny v Brně, Brno, Czechia|Centre Hospitalier Universitaire Amiens-Picardie, Amiens, France|Centre Hospitalier Regional Metz-Thionville, Ars-Laquenexy, France|Centre Hospitalier Régional Universitaire de Besançon, Besançon, France|Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France|CHU APHP Ambroise-Paré, Boulogne-Billancourt, France|Centre Hospitalier Andrée Rosemon, Cayenne, France|CHU Clermont-Ferrand, Clermont-Ferrand, France|Hospices Civil, Colmar, France|APHP - hôpital Henri-Mondor, Créteil, France|Centre Hospitalier Universitaire Dijon-Bourgogne, Dijon, France|Centre Hospitalier Universitaire de Martinique, Fort De France, France|AP-HP Hôpital Bicêtre, Kremlin-Bicêtre, France|Centre Hospitalo-Universitaire de Grenoble, La Tronche, France|Centre hospitalier de Versailles, Le Chesnay, France|Centre Hospitalier Régional Universitaire de Lille, Lille, France|Hospices Civils de Lyon, Lyon, France|Centre Hospitalier de Mont de Marsan, Mont-de-Marsan, France|Centre Hospitalier Universitaire de Montpellier, Montpellier, France|Groupe Hospitalier de la Région de Mulhouse Sud Alsace, Mulhouse, France|Centre Hospitalier Régional et Universitaire de Nancy, Nancy, France|Centre Hospitalier Universitaire de Nantes, Nantes, France|Centre Hospitalo-Universitaire de Nice, Nice, France|CHU Nîmes, Nîmes, France|APHP - Hôpital Lariboisière, Paris, France|APHP - Hôpital Saint Louis, Paris, France|APHP - Hôpital Saint Antoine, Paris, France|APHP - Hôpital Universitaire Pitié Salpêtrière, Paris, France|APHP - Hôpital Cochin, Paris, France|Hôpital Paris Saint-Joseph et Marie Lannelongue, Paris, France|APHP - Hôpital Necker, Paris, France|APHP- Hôpital Européen Georges-Pompidou, Paris, France|APHP - Hôpital Bichat Claude Bernard, Paris, France|APHP - Hôpital Tenon, Paris, France|CHU Poitiers, Poitiers, France|CH Cornouaille, Quimper, France|CHU de Reims, Reims, France|Centre Hospitalier Universitaire de Rennes, Rennes, France|Hopital DELAFONTAINE, Saint-Denis, France|Hôpital d'Instruction des Armées BEGIN, Saint-Mandé, France|Centre Hospitalier Universitaire de Saint Etienne, Saint-Étienne, France|Centre Hospitalier Régional Universitaire de Strasbourg, Strasbourg, France|Centre Hospitalier Universitaire de Toulouse, Toulouse, France|Centre Hospitalier Universitaire de Toulouse, Toulouse, France|Centre Hospitalier de Tourcoing, Tourcoing, France|Centre Hospitalier Universitaire de Tours, Tours, France|CH Bretagne Atlantique, Vannes, France|CH Bretagne Atlantique, Vannes, France|Centre Hospitalier Annecy Genevois, Épagny, France|Evaggelismos General Hospital, Athens, Greece|General University Hospital of Patras, Patras, Greece|hospital Saint James, Dublin, Ireland|Centre Hospitalier Luxembourg, Luxembourg, Luxembourg|Hôpitaux Robert Schuman, Luxembourg, Luxembourg|Akershus Unniversity Hospital, Oslo, Norway|Lovisenberg Diaconal Hospital, Oslo, Norway|Oslo University Hospital, Oslo, Norway|Bienganski Hospital, Łódź, Poland|Hospital de Abrantes (CHMT), Abrantes, Portugal|Hospital de Cascais, Cascais, Portugal|CHULN- Hospital de Santa Maria, Lisboa, Portugal|CHULN- Hospital de Santa Maria, Lisboa, Portugal|Centro Hospitalar Universitário de São João, EPE, Porto, Portugal|Martin University Hospital, Martin, Slovakia
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 2416
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Percentage of subjects reporting each severity rating on a 7-point ordinal scale|Status on an ordinal scale|National Early Warning Score 2 (NEWS-2 score)|Number of oxygenation free days in the first 28 days|Incidence of new oxygen use, non-invasive ventilation or high flow oxygen devices during the trial.|Ventilator free days in the first 28 days|Incidence of new mechanical ventilation use during the trial.|Need for mechanical ventilation or death by Day 15|Hospitalization|Mortality|Occurrence of new hospitalization|Occurrence of confirmed re-infection with SARS-CoV-2|Cumulative incidence of serious adverse events (SAEs)|Cumulative incidence of Grade 1- 2 hypersensitivity- related and infusion related AEs until D29 visit|Cumulative incidence of Grade 3 and 4 adverse events (AEs)|Number of participants with a discontinuation or temporary suspension of study drugs (for any reason)|Cumulative incidence of AEs of Special Interest
|
NCT04409483
|
Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger |
Withdrawn |
Phase 3 |
Jun/01/2020 |
Dec/31/2020 |
- Alternative id - Trascov
- Interventions - Drug: Lopinavir-Ritonavir Drug Combination|Combination Product: Standard Care
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 0
- Age - 12 Years and older (Child, Adult, Older Adult)
- Outcome measures - Hospitalization or death|All-cause mortality|Time to hospitalization|Length of hospitalization|Admission to intensive care|Adverse events|Serious adverse events
|
NCT04328285
|
Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers |
Active, not recruiting |
Phase 3 |
Apr/14/2020 |
Mar/30/2022 |
- Alternative id - 20PH061|2020-001188-96
- Interventions - Drug: Hydroxychloroquine|Drug: Placebo of Hydroxychloroquine|Drug: Lopinavir and ritonavir|Drug: Placebo of LPV/r Tablets
- Study type - Interventional
- Study results - No Results Available
- Locations - CHU d'Angers, Angers, France|CHU de Bordeaux, Bordeaux, France|CHU de Clermont-Ferrand, Clermont-ferrand, France|CHU de Montpellier, Montpellier, France|CHU de Nancy, Nancy, France|CHU de Nantes, Nantes, France|CHU de Rennes, Rennes, France|CHU de Rouen, Rouen, France|CHU de Saint-Etienne, Saint-Étienne, France
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 1200
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Occurrence of an symptomatic or asymptomatic SARS-CoV-2 infection among healthcare workers (HCWs)|Evaluation of the occurrence of adverse events in each arm,|Evaluation of the discontinuation rates of the investigational drug in each arm,|Evaluation of the adherence of participants to study drug,|Evaluation of the incidence of symptomatic cases of SARS-CoV-2 infection in each arm,|Evaluation of the incidence of asymptomatic cases of SARS-CoV-2 infection in each arm|Evaluation of the incidence of severe cases of SARS-CoV-2 infection in each arm.|corrected QT interval (ms)
|
NCT04425382
|
Darunavir/Cobicistat vs. Lopinavir/Ritonavir in COVID-19 Pneumonia in Qatar |
Recruiting |
|
Mar/01/2020 |
Sep/01/2020 |
- Alternative id - MRC-05-069
- Interventions - Drug: Darunavir/Cobicistat|Drug: Lopinavir/Ritonavir
- Study type - Observational
- Study results - No Results Available
- Locations - Hamad Medical Corporation, Doha, Qatar
- Study designs - Observational Model: Other|Time Perspective: Retrospective
- Enrollment - 200
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Time to Clinical Improvement and/or Virological Clearance (Composite Endpoint)|Percentage of Virological Clearance|Percentage of Clinical Deterioration|Incidence of Adverse Events|Length of Hospital Stay|All-cause Mortality
|
NCT04276688
|
Lopinavir/ Ritonavir, Ribavirin and IFN-beta Combination for nCoV Treatment |
Completed |
Phase 2 |
Feb/10/2020 |
Mar/31/2020 |
- Alternative id - UW-20-074
- Interventions - Drug: Lopinavir/ritonavir|Drug: Ribavirin|Drug: Interferon Beta-1B
- Study type - Interventional
- Study results - No Results Available
- Locations - University of Hong Kong, Queen Mary Hospital, Hong Kong, Hong Kong
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 127
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Time to negative NPS|Time to negative saliva|Time to clinical improvement|Hospitalisation|Mortality|Immune reaction|Adverse events|Time to negative all clinical specimens
|
NCT04380818
|
Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19 |
Recruiting |
Not Applicable |
Jun/05/2020 |
Nov/01/2021 |
- Alternative id - IPACOVID
- Interventions - Radiation: Low-dose radiotherapy|Drug: Hydroxychloroquine Sulfate|Drug: Ritonavir/lopinavir|Drug: Tocilizumab Injection [Actemra]|Drug: Azithromycin|Drug: Corticosteroid|Drug: Low molecular weight heparin|Device: Oxygen supply
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital Sant Joan de Reus, Reus, Tarragona, Spain|Hospital Del Mar, Barcelona, Spain|Hospital Universitario Madrid Sanchinarro, Madrid, Spain
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care
- Enrollment - 106
- Age - 18 Years to 99 Years (Adult, Older Adult)
- Outcome measures - Efficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20%|Number of participants with treatment-related adverse events as assessed by CTCAE v5.0|Change of the radiological image|Overall mortality|Measure of pro-inflammatory interleukins|Measure of trasforming growth factor (TGF-b)|Measure of tumor necrosis factor alpha (TNF-a)|Determining overexpression of pro-inflammatory selectin|Determining cell adhesion molecules (CAMs)|Measure of marker of oxidative stress PON-1
|
NCT04275388
|
Xiyanping Injection for the Treatment of New Coronavirus Infected Pneumonia |
Not yet recruiting |
|
May/15/2020 |
Dec/14/2021 |
- Alternative id - QF-XYP2001-1
- Interventions - Drug: Xiyanping injection|Drug: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride
- Study type - Observational
- Study results - No Results Available
- Locations -
- Study designs - Observational Model: Cohort|Time Perspective: Retrospective
- Enrollment - 426
- Age - up to 100 Years (Child, Adult, Older Adult)
- Outcome measures - Clinical recovery time|Complete fever time|Cough relief time|Virus negative time|Incidence of severe or critical neocoronavirus pneumonia
|
NCT04345276
|
Efficacy and Safety of Ganovo (Danoprevir) Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection |
Completed |
Phase 4 |
Mar/18/2020 |
Apr/15/2020 |
- Alternative id - ASC-CTP-HS-01
- Interventions - Drug: Danoprevir+Ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations - Huoshenshan Hostipal, Wuhan, Hubei, China
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 10
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Rate of composite adverse outcomes|Time to recovery|Rate of no fever|Rate of no cough|Rate of no dyspnea|Rate of no requiring supplemental oxygen|Rate of undetectable New coronavirus pathogen nucleic acid|Rate of mechanical ventilation|Rate of ICU admission|Rate of serious adverse event
|
NCT05261139
|
EPIC-Peds: Study of Oral PF-07321332 (Nirmatrelvir)/Ritonavir in Nonhospitalized COVID-19 Pediatric Patients at Risk for Severe Disease |
Not yet recruiting |
Phase 3 |
Mar/02/2022 |
Mar/04/2023 |
- Alternative id - C4671026
- Interventions - Drug: nirmatrelvir|Drug: ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations - SKY Clinical Research Network Group-Quinn, Ridgeland, Mississippi, United States|Coastal Pediatric Research, Summerville, South Carolina, United States|Consano Clinical Research, LLC, Shavano Park, Texas, United States
- Study designs - Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 140
- Age - up to 18 Years (Child, Adult)
- Outcome measures - Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir|Cohort 3-5: Cmax of nirmatrelvir and ritonavir|Cohort 1-2: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir|Cohort 3-5: AUC0-tau of nirmatrelvir and ritonavir|Incidence of TEAEs, SAEs, AEs leading to discontinuations, and vital sign measurements|Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasal swabs over time|Proportion of participants with COVID-19 related hospitalization or death from any cause|Patient assessment on palatability of nirmatrelvir (film-coated tablets and age-appropriate formulation)|Patient assessment on palatability of ritonavir (age-appropriate formulation)|Patient assessment on acceptability of nirmatrelvir (film-coated tablets and age-appropriate formulation)|Patient assessment on acceptability of ritonavir (age-appropriate formulation)
|
NCT04381936
|
Randomised Evaluation of COVID-19 Therapy |
Recruiting |
Phase 2|Phase 3 |
Mar/19/2020 |
Nov/01/2032 |
- Alternative id - NDPHRECOVERY|2020-001113-21|ISRCTN50189673
- Interventions - Drug: Lopinavir-Ritonavir|Drug: Corticosteroid|Drug: Hydroxychloroquine|Drug: Azithromycin|Biological: Convalescent plasma|Drug: Tocilizumab|Biological: Immunoglobulin|Drug: Synthetic neutralising antibodies|Drug: Aspirin|Drug: Colchicine|Drug: Baricitinib|Drug: Anakinra|Drug: Dimethyl fumarate|Drug: High Dose Corticosteroid|Drug: Empagliflozin|Drug: Sotrovimab
- Study type - Interventional
- Study results - No Results Available
- Locations - Kumasi Center for Collaborative Research in Tropical Medicine KNUST, Kumasi, Ghana|Indian Council of Medical Research, Division of Epidemiology and Communicable Diseases, New Delhi, India|Eijkman Oxford Clinical Research Unit (EOCRU), Eijkman Institute for Molecular Biology, Jakarta, Indonesia|Clinical Trial Unit, Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Sciences, Kathmandu, Nepal|Wits Health Consortium, Johannesburg, South Africa|RECOVERY Sri Lanka & Pakistan, National Intensive Care Surveillance - M.O.R.U, Colombo, Sri Lanka|Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom|Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 50000
- Age - Child, Adult, Older Adult
- Outcome measures - All-cause mortality|Duration of hospital stay|Composite endpoint of death or need for mechanical ventilation or ECMO
|
NCT05032950
|
Drug-Drug Interaction Study to Estimate the Effect of PF-07321332/Ritonavir and Ritonavir on Midazolam in Healthy Participants |
Completed |
Phase 1 |
Sep/17/2021 |
Dec/09/2021 |
- Alternative id - C4671013|2021-003590-62
- Interventions - Drug: Midazolam|Drug: PF-07321332/ritonavir + Midazolam|Drug: Ritonavir + Midazolam
- Study type - Interventional
- Study results - No Results Available
- Locations - Brussels Clinical Research Unit, Brussels, Bruxelles-capitale, Région DE, Belgium
- Study designs - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 12
- Age - 18 Years to 60 Years (Adult)
- Outcome measures - Maximum Observed Plasma Concentration (Cmax) of midazolam when administered alone|Cmax of midazolam when administered with PF-07321332/ritonavir|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of midazolam when administered alone|AUCinf of midazolam when administered with PF-07321332/ritonavir|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of midazolam when administered alone|AUClast of midazolam when administered with PF-07321332/ritonavir|Assessment of Participants With Treatment-Emergent Adverse Events (TEAEs) of PF-07321332/Ritonavir|Assessment of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities of PF-07321332/Ritonavir|Assessment of Participants With Clinically Significant Change From Baseline in Vital Signs of PF-07321332/Ritonavir|Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings of PF-07321332/Ritonavir|Cmax of midazolam when administered with ritonavir|AUCinf of midazolam when administered with ritonavir|AUClast of midazolam when administered with ritonavir|Apparent Oral Clearance (CL/F) of midazolam when administered alone|CL/F of midazolam when administered with PF-07321332/ritonavir|Apparent Oral Volume of Distribution (Vz/F)) of midazolam when administered alone|Vz/F of midazolam when administered with PF-07321332/ritonavir|Time to Cmax (Tmax) of midazolam when administered alone|Tmax of midazolam when administered with PF-07321332/ritonavir|Plasma Decay Half-Life (t1/2) of midazolam when administered alone|t1/2 of midazolam when administered with PF-07321332/ritonavir
|
NCT04909853
|
Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function. |
Completed |
Phase 1 |
Jun/15/2021 |
Oct/07/2021 |
- Alternative id - C4671011
- Interventions - Drug: PF-07321332/ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations - Orange County Research Center, Tustin, California, United States|Investigational Drug Services (IDS) University of Miami Hospitals and Clinics, Miami, Florida, United States|University of Miami Division of Clinical Pharmacology, Miami, Florida, United States|Genesis Clinical Research, Tampa, Florida, United States|Prism Research LLC dba Nucleus Network, Saint Paul, Minnesota, United States
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 35
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Maximum observed plasma concentration (Cmax) for PF-07321332.|Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-07321332|Amount of PF-07321332 excreted in urine unchanged|Time to maximum concentration (Tmax) of PF-07321332|Area Under the Plasma Concentration-time Profile from Time 0 to Last Measurable PF-07321332 Concentration (AUClast)|Number of Participants reporting Treatment-Emergent Adverse Events|Number of Participants With Clinical Laboratory Abnormalities|Number of Participants With Vital Signs Abnormalities|Number of Participants With Abnormalities in Physical Examination|Number of Participants With Abnormal Electrocardiogram (ECG)
|
NCT04386876
|
Bioequivalence Study of Lopinavir/Ritonavir 200/50 mg Film Tablet (World Medicine Ilac, Turkey) Under Fasting Conditions |
Completed |
Phase 1 |
Apr/30/2020 |
Jun/11/2020 |
- Alternative id - NOV2020/01911|FARGE365
- Interventions - Drug: Lopinavir/Ritonavir 200 mg/50 mg Film Tablet|Drug: Lopinavir/Ritonavir 200 mg/50 mg Film Coated Tablet
- Study type - Interventional
- Study results - No Results Available
- Locations - Novagenix Drug R&D Center, Akyurt, Ankara, Turkey|Farmagen Ar-Ge Biyot. Ltd. Sti., Sahinbey, Gaziantep, Turkey
- Study designs - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Other
- Enrollment - 30
- Age - 20 Years to 40 Years (Adult)
- Outcome measures - Primary PK End Points
|
NCT04261907
|
Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Novel Coronavirus Infection |
Unknown status |
Not Applicable |
Feb/07/2020 |
Jun/30/2020 |
- Alternative id - ASC09F-CTP-ZY-01
- Interventions - Drug: ASC09/ritonavir group|Drug: lopinavir/ritonavir group
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 160
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - The incidence of composite adverse outcome|Time to recovery|Rate of no fever|Rate of no cough|Rate of no dyspnea|Rate of no requring supplemental oxygen|Rate of undectable viral RNA|Rate of mechanical ventilation|Rate of ICU admission|Time and rate of laboratory indicators related to disease improvement to return to normal
|
NCT04455958
|
Lopinavir/Ritonavir for the Treatment of COVID-19 Positive Patients With Cancer and Immune Suppression in the Last Year |
Withdrawn |
Phase 2 |
May/01/2021 |
Nov/01/2021 |
- Alternative id - STUDY00021444|NCI-2020-02877
- Interventions - Drug: Lopinavir/Ritonavir|Drug: Placebo Administration|Other: Questionnaire Administration
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 0
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Severity of symptoms|Clinical benefit rate of lopinavir/ritonavir|Time to symptom progression|Time to improvement of participants|Time to hospital admission for those who develop severe of critical symptoms|Intensive care unit (ICU) admission: yes or no|Receiving ventilator support: yes or no|Overall survival
|
NCT04354428
|
Treatment for COVID-19 in High-Risk Adult Outpatients |
Active, not recruiting |
Phase 2|Phase 3 |
Apr/16/2020 |
Jan/01/2021 |
- Alternative id - STUDY00009878|INV-017062
- Interventions - Drug: Ascorbic Acid|Drug: Hydroxychloroquine Sulfate|Drug: Azithromycin|Drug: Folic Acid|Drug: Lopinavir 200 MG / Ritonavir 50 MG [Kaletra]
- Study type - Interventional
- Study results - No Results Available
- Locations - Ruth M. Rothstein CORE Center - Cook County Health, Chicago, Illinois, United States|Tulane University, New Orleans, Louisiana, United States|Boston University, Boston, Massachusetts, United States|SUNY Upstate Medical University, Syracuse, New York, United States|University of Washington Coordinating Center, Seattle, Washington, United States|UW Virology Research Clinic, Seattle, Washington, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 300
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - Lower respiratory tract infection (LRTI) rates|Incidence of hospitalization or mortality|Change in upper respiratory viral shedding|COVID-19 symptom resolution rates [Lopinavir-ritonavir arm only]|Rate of participant-reported adverse events|COVID-19-related hospitalization days|Rate of disease severity|Viral shedding rates|Individual lopinavir-ritonavir concentration profiles and exposure estimates [Lopinavir-ritonavir arm only]
|
NCT04960202
|
EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19 |
Active, not recruiting |
Phase 3 |
Jul/16/2021 |
Apr/23/2022 |
- Alternative id - C4671005|2021-002895-38|EPIC-HR
- Interventions - Drug: PF-07321332|Drug: Ritonavir|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Cahaba Research, Inc., Pelham, Alabama, United States|The Institute for Liver Health dba Arizona Clinical Trials, Mesa, Arizona, United States|The Institute for Liver Health dba Arizona Clinical Trials, Tucson, Arizona, United States|Hope Clinical Research, Canoga Park, California, United States|Ascada Research, Fullerton, California, United States|Atella Clinical Research LLC., La Palma, California, United States|Ark Clinical Research, Long Beach, California, United States|American Institute of Research, Los Angeles, California, United States|South Bay Clinical Research Institute, Torrance, California, United States|Hope Clinical Research (COVID Satellite Site), West Hills, California, United States|Future Innovative Treatments, LLC, Colorado Springs, Colorado, United States|Xera Med Research, Boca Raton, Florida, United States|MOORE Clinical Research, Inc., Brandon, Florida, United States|Innovative Research of West Florida, Inc., Clearwater, Florida, United States|Herco Medical and Research Center Inc, Coral Gables, Florida, United States|Advance Clinical Research Group, Cutler Bay, Florida, United States|Beautiful Minds Clinical Research Center, Cutler Bay, Florida, United States|Unlimited Medical Research Group, LLC, Hialeah Gardens, Florida, United States|Qway Research, LLC, Hialeah, Florida, United States|Eastern Research Inc, Hialeah, Florida, United States|Inpatient Research Clinic, Hialeah, Florida, United States|Doral Medical Research LLC., Hialeah, Florida, United States|Doral Medical Research,LLC, Hialeah, Florida, United States|Advanced Pulmonary Research Institute, Loxahatchee Groves, Florida, United States|Savin Medical Group, LLC, Miami Lakes, Florida, United States|Angels Clinical Research Institute, Miami, Florida, United States|LCC Medical Research Institute, LLC, Miami, Florida, United States|Premium Medical Research Corp, Miami, Florida, United States|Global Health Clinical Trials Corp, Miami, Florida, United States|South Florida Research Center, Inc., Miami, Florida, United States|Suncoast Research Group, LLC, Miami, Florida, United States|I.V.A.M. Clinical & Investigational Center, LLC, Miami, Florida, United States|C'A Research, Miami, Florida, United States|ProLive Medical Research, Corp., Miami, Florida, United States|Entrust Clinical Research, Miami, Florida, United States|Reed Medical Research, Miami, Florida, United States|Kendall South Medical Center, Miami, Florida, United States|Clinical Site Partners, Inc d/b/a CSP Miami, Miami, Florida, United States|Coral Research Clinic Corp, Miami, Florida, United States|Omega Research Orlando, LLC, Orlando, Florida, United States|NAPA Research LLC, Pompano Beach, Florida, United States|CDC Research Institute, Port Saint Lucie, Florida, United States|GCP, Global Clinical Professionals, Saint Petersburg, Florida, United States|GCP, Global Clinical Professionals, Saint Petersburg, Florida, United States|USPA Advance Concept Medical Research Group LLC, South Miami, Florida, United States|Sunrise Research Institute, Sunrise, Florida, United States|Santos Research Center, CORP, Tampa, Florida, United States|Clinical Site Partners, Inc. dba CSP Orlando, Winter Park, Florida, United States|Research by Design, LLC, Chicago, Illinois, United States|New Orleans Sinus Center (COVID-19 Testing), Marrero, Louisiana, United States|Tandem Clinical Research GI, LLC, Marrero, Louisiana, United States|Mercury Street Medical Group, PLLC, Butte, Montana, United States|Excel Clinical Research, Las Vegas, Nevada, United States|Meridian Clinical Research, LLC, Endwell, New York, United States|Monroe Biomedical Research, Monroe, North Carolina, United States|Accellacare, Wilmington, North Carolina, United States|Premier Medical Group, Clarksville, Tennessee, United States|PharmaTex Research, LLC, Amarillo, Texas, United States|ARC Clinical Research at William Cannon, Austin, Texas, United States|St Hope Foundation, Bellaire, Texas, United States|Conroe Willis Medical Research, Conroe, Texas, United States|South Texas Clinical Research, Corpus Christi, Texas, United States|SignatureCare Emergency Center, Houston, Texas, United States|Trio Clinical Trials, LLC, Houston, Texas, United States|C & R Research Services USA, Houston, Texas, United States|Next Level Urgent Care, Houston, Texas, United States|SMS Clinical Research, LLC, Mesquite, Texas, United States|SMS Clinical Research, Mesquite, Texas, United States|LinQ Research, LLC, Pearland, Texas, United States|Epic Medical Research, Red Oak, Texas, United States|Sun Research Institute, San Antonio, Texas, United States|BFHC Research, San Antonio, Texas, United States|Tranquility Research, Webster, Texas, United States|TPMG (Tidewater Physicians Multispecialty Group) Clinical Research, Newport News, Virginia, United States|Instituto de Investigaciones Clinicas Zarate, Zarate, Buenos Aires, Argentina|Hospital De Clínicas Presidente Dr.Nicolas Avellaneda, San Miguel de Tucuman, Tucuman, Argentina|Chronos Pesquisa Clinica, Brasilia, Distrito Federal, Brazil|Hospital Agamenon Magalhaes, Recife, Pernambuco, Brazil|Centro de Estudos Clinicos do Interior Paulista (CECIP), Jau, SAO Paulo, Brazil|Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD, Burgas, Bulgaria|"Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd, Haskovo, Bulgaria|MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD, Kozloduy, Bulgaria|Diagnostic-Consultative Center I Lom EOOD, Lom, Bulgaria|Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD, Lom, Bulgaria|Medical centre Leo Clinic EOOD, Lovech, Bulgaria|MHAT Heart and Brain EAD, Pleven, Bulgaria|DCC Sveti Georgi EOOD, Plovdiv, Bulgaria|MHAT "St. Panteleimon "- Plovdiv, Plovdiv, Bulgaria|Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD, Razgrad, Bulgaria|"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -, Ruse, Bulgaria|UMHAT Medica Ruse OOD, Ruse, Bulgaria|Multiprofile Hospital for Active Treatment - Samokov EOOD, Samokov, Bulgaria|Medical Center-1-Sevlievo EOOD, Sevlievo, Bulgaria|Multiprofile Hospital For Active Treatment Shumen AD, Shumen, Bulgaria|Multiprofile hospital for active treatment - Sliven to Military Medical Academy, Sliven, Bulgaria|MHAT "Dr. Ivan Seliminski" AD, Sliven, Sliven, Bulgaria|Diagnostic-Consultative Center XXII- Sofia ЕООD, Sofia, Bulgaria|MHAT "St. Sofia" EOOD, Sofia, Bulgaria|Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD, Stara Zagora, Bulgaria|Multiprofile Hospital for Active Treatment Targovishte AD, Targovishte, Bulgaria|Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD, Tsarevo, Bulgaria|Medical center Leo Clinic EOOD, Varna, Bulgaria|Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD, Vratsa, Bulgaria|Fundacion Cardiomet CEQUIN, Armenia, Quindio, Colombia|Zdraví-Fit, s.r.o., Protivín, Czechia|Nemocnice Slany, Slany, Czechia|Trial Pharma Kft., Bekescsaba, Hungary|Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika, Debrecen, Hungary|Agria-Study Kft., Eger, Hungary|Trial Pharma Kft., Gyula, Hungary|Medifarma-98 Kft., Nyiregyhaza, Hungary|AIIMS Raipur, Raipur, Chhattisgarh, India|Jupiter Hospital, Vadodara, Gujarat, India|BGS Global Institute of Medical Sciences and Hospital, Bangalore, Karnataka, India|Lisie Hospital, Kochi, Kerala, India|Jehangir Clinical Development Centre Pvt. Ltd, Pune, Maharashtra, India|Lifepoint Research LLP, Pune, Maharashtra, India|Jawahar Lal Nehru Medical College, Ajmer, Rajasthan, India|Apex Hospitals Pvt Ltd, Jaipur, Rajasthan, India|Maharaja Agrasen Superspeciality Hospital, Jaipur, Rajasthan, India|Nil Ratan Sircar Medical College and Hospital, Kolkata, WEST Bengal, India|Aakash Healthcare Private Limited, New Delhi, India|Sardar Patel Medical College, Pavan PURI Bikaner, Rajasthan, India|International University of Health and Welfare Narita Hospital, Narita, Chiba, Japan|National Hokkaido Medical Center, Sapporo, Hokkaido, Japan|Rinku General Medical Center, Izumisano, Osaka, Japan|Tokyo Medical University Hachioji Medical Center, Hachioji, Tokyo, Japan|National Center for Global Health and Medicine, Shinjuku City, Tokyo, Japan|Kyungpook National University Chilgok Hospital, Daegu, Korea, Republic of|Incheon Medical Center, Incheon, Korea, Republic of|Chonnam National University Bitgoeul Hospital, Nam-gu, Korea, Republic of|SMG-SNU Boramae Medical Center, Seoul, Korea, Republic of|Hospital Umum Sarawak, Kuching, Sarawak, Malaysia|Hospital Miri, Miri, Sarawak, Malaysia|Clinical Research Institute Saltillo S.A. de C.V., Saltillo, Coahuila, Mexico|Asociacion Mexicana para la Investigacion Clinica A.C. (AMIC), Pachuca de Soto, Hidalgo, Mexico|Instituto Jalisciense de Metabolismo, CS, Guadalajara, Jalisco, Mexico|JM Research, Cuernavaca, Morelos, Mexico|Christus - Latam Hub Center of Excellence and Innovation Center S.C., Monterrey, Nuevo LEON, Mexico|Eukarya Pharmasite S.C., Monterrey, Nuevo LEON, Mexico|Oaxaca Site Management Organization, Oaxaca de Juarez, Oaxaca, Mexico|InfectoLab Consultorios de Especialidad en Infectologia, Baja California, Tijuana, Mexico|Kohler & Milstein Research S.A. de C.V., Merida, Yucatan, Mexico|Eme Red Hospitalaria, Mérida, Yucatán, Mexico|Centro de Investigacion Clinica Del Pacifico SA de CV, Acapulco, Mexico|Hospital Cardiologica Aguascalientes, Aguascalientes, Mexico|Instituto de Investigaciones Clínicas para la Salud, Durango, Mexico|FAICIC S. de R.L. de C.V., Veracruz, Mexico|Sociedad de Metabolismo y Corazon S.C., Veracruz, Mexico|Arke SMO S.A. de C.V, Veracruz, Mexico|KLIMED Marek Klimkiewicz, Bialystok, Poland|Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska, Wroclaw, Poland|Clinical Research Management Group Inc, Ponce, Puerto Rico|Advance Medical Research Center, San Juan, Puerto Rico|LLC Trekhgorka Medicine, Odintsovo, Moscow Region, Russian Federation|Barnaul City Hospital Number 5, Barnaul, Russian Federation|KDC "Evromedservis", OJSC, Moscow, Russian Federation|Smolensk State Medical University, Smolensk, Russian Federation|MERC Welkom, Welkom, FREE State, South Africa|East Rand Research Centre T/A Worthwhile Clinical Trials, Benoni, Gauteng, South Africa|Botho ke Bontle Health Services, Pretoria, Gauteng, South Africa|Synapta Clinical Research Center, Durban, Kwazulu Natal, South Africa|Limpopo Clinical Research Initiative, Thabazimbi, Limpopo, South Africa|MERC Middelburg, Middelburg, Mpumalanga, South Africa|Eba Centelles, Centelles, Barcelona [barcelona], Spain|Complexo Hospitalario Universitario da Coruna, A Coruña, Spain|Bangkok Centre Hotel, Bangrak, Bangkok, Thailand|Chula Filed hospital, Chulalongkorn University Sport center (Chantanayingyong Gymnasium),, Pathum Wan District,, Bangkok, Thailand|Thai Red Cross Emerging Infectious Diseases (EDI) Clinic, Pathumwan,, Bangkok, Thailand|The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),, Pathumwan, Bangkok, Thailand|Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,, Hat Yai, Songkhla, Thailand|Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand|Ankara University Medical Faculty, Ibni-Sina Hospital, Ankara, Turkey|Hacettepe University Medical Faculty Hospital, Ankara, Turkey|Akdeniz Universitesi Hastanesi, Antalya, Turkey|Istanbul Medipol University Clinical Research Ethics Committee, Beykoz / Istanbul, Turkey|Gaziantep University Medical Faculty, Gaziantep, Turkey|Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi, Istanbul, Turkey|Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty, Istanbul, Turkey|Acibadem Saglik Hizmetleri ve Tic.A.S, Acibadem Atakent Hastanesi, Istanbul, Turkey|Istanbul Universitesi Klinik Arastirmalar Mukemmeliyet Uygulama ve Arastirma Merkezi, Istanbul, Turkey|Basaksehir Cam ve Sakura Sehir Hastanesi, Istanbul, Turkey|Kocaeli University Medical Faculty, Kocaeli, Turkey|Sbü Dr. Suat Seren Göğüs Hastaliklari Ve Cerrahisi Eğitim Ve Araştirma Hastanesi, Konak/Izmir, Turkey|Mersin University Health Research and Application Hospital, Mersin, Turkey|Sakarya University Training and Research Hospital, Sakarya, Turkey|Karadeniz Teknik Universitesi Farabi Hastanesi, Trabzon, Turkey|Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council, Dnipro, Ukraine|Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of, Ivano-Frankivsk, Ukraine|Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council", Ivano-Frankivsk, Ukraine|Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council, Kharkiv, Ukraine|Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases, Kharkiv, Ukraine|"Municipal Non-Profit Enterprise "Alexander Clinical Hospital of Kyiv" of the Kyiv City Council, Kyiv, Ukraine|Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv, Kyiv, Ukraine|Kyiv Railway Clinical Hospital No.2 of Branch "Health Center of the Public Joint Stock Company, Kyiv, Ukraine|Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company, Kyiv, Ukraine|Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analitical, Lviv, Ukraine|Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4", Lviv, Ukraine|Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional, Poltava, Ukraine|Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council, Tarasove Village, Ukraine|Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1", Vinnytsia, Ukraine|Communal Enterprise "Hospital #1" of Zhytomyr City Council, Zhytomyr, Ukraine
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 2246
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Proportion of participants with COVID-19 related hospitalization or death from any cause|Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)of PF-07321332/ritonavir relative to placebo|Incidence of Treatment-emergent Adverse Events (TEAEs) of PF-07321332/ritonavir relative to placebo of PF-07321332/ritonavir relative to placebo|Duration of each targeted COVID-19 sign/symptom|Severity of each targeted COVID-19 sign/symptom|Proportion of participants with death (all cause)|To determine the pharmacokinetics (PK) in plasma and whole blood of PF-07321332 in nonhospitalized symptomatic adult participants with COVID 19 who are at increased risk of progression to severe disease|Viral titers measured by Reverse Transcription Polymerase Chain Reaction (RT-PCR) in nasal swabs|Number of COVID-19 related medical visits other than hospitalization|Number of days in hospital and intensive care unit for the treatment of COVID-19
|
NCT04343768
|
An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial |
Completed |
Phase 2 |
Apr/09/2020 |
Apr/27/2020 |
- Alternative id - Different Interferons in COVID
- Interventions - Drug: Hydroxychloroquine|Drug: Lopinavir / Ritonavir|Drug: Interferon Beta-1A|Drug: Interferon Beta-1B
- Study type - Interventional
- Study results - No Results Available
- Locations - Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences and Health Services, Tehran, Iran, Islamic Republic of
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 60
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Time to clinical improvement|Mortality|SpO2 Improvement|Incidence of new mechanical ventilation use|Duration of hospitalization
|
NCT04372628
|
Trial of Early Therapies During Non-hospitalized Outpatient Window for COVID-19 |
Active, not recruiting |
Phase 2 |
Jun/01/2020 |
Jun/01/2022 |
- Alternative id - 200827
- Interventions - Drug: Lopinavir/Ritonavir 400 mg/100 mg|Other: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - University of Colorado School of Medicine, Aurora, Colorado, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|University of Mississippi Medical Center, Jackson, Mississippi, United States|Vanderbilt University Medical Center, Nashville, Tennessee, United States|Intermountain, Murray, Utah, United States|University of Wisconsin, Madison, Wisconsin, United States
- Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 600
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Modified COVID Ordinal Outcomes Scale: Study Day 15|Modified COVID Ordinal Outcome Scale: Study Day 8|Modified COVID Ordinal Outcome Scale: Study Day 29|Proportion of patients hospitalized: Day 1 to 29|Time to hospitalization Day 1 to Day 29|Time to symptom resolution: Day 1 to Day 29|All-cause, all-location mortality: Day 1 to Day 29|Oxygen-free days: Day 1 to Day 29|Fever-free days: Day 1 to Day 29|Ventilator-free days: Day 1 to Day 29|ICU-free days: Day 1 to Day 29|Hospital-free days: Day 1 to Day 29
|
NCT04364022
|
Efficacy of Pragmatic Same-day COVID-19 Ring Prophylaxis for Adult Individuals Exposed to SARS-CoV-2 in Switzerland |
Completed |
Phase 3 |
Apr/23/2020 |
Mar/24/2021 |
- Alternative id - CCER 2020-00864
- Interventions - Drug: Lopinavir/ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations - Instituto Nacional de Infectiologia Evandro Chagas, Fiocruz, Rio De Janeiro, Brazil|Universitätsspital Basel and SwissTPH, Basel, Switzerland|Hôpitaux Universitaires de Genève, Geneva, Switzerland|Ospedale Regionale di Lugano, Lugano, Switzerland
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 326
- Age - 16 Years and older (Child, Adult, Older Adult)
- Outcome measures - 21-day incidence of COVID-19 in individuals exposed to SARS-CoV- 2 who are asymptomatic at baseline (intent-to-treat (ITT) analysis).|21-day incidence of COVID-19 in individuals exposed to SARS-CoV- 2 who are asymptomatic, PCR-confirmed SARS-CoV-2 negative and have negative SARS-CoV-2 serology at baseline (modified ITT)|21-day incidence of SARS-CoV-2 infection in individuals exposed to SARS-CoV-2 who are asymptomatic, PCR-confirmed SARS-CoV-2 negative and have negative SARS-CoV-2 serology at baseline (modified ITT)|Severity of clinical COVID-19 on a 7-point ordinal scale
|
NCT04252885
|
The Efficacy of Lopinavir Plus Ritonavir and Arbidol Against Novel Coronavirus Infection |
Completed |
Phase 4 |
Jan/28/2020 |
May/31/2020 |
- Alternative id - GZ8H-V1.0 20200122
- Interventions - Drug: Lopinavir and Ritonavir Tablets|Drug: Arbidol
- Study type - Interventional
- Study results - No Results Available
- Locations - Guangzhou Eighth People's Hospital, Guangzhou, Guangdong, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 86
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - The rate of virus inhibition|The disease prorogation-temperature|The disease prorogation-respiratory function 1|The disease prorogation-respiratory function 2|The disease prorogation-respiratory function 3
|
NCT04286503
|
The Clinical Study of Carrimycin on Treatment Patients With COVID-19 |
Unknown status |
Phase 4 |
Feb/23/2020 |
Feb/28/2021 |
- Alternative id - BeijingYouan Hospital
- Interventions - Drug: Carrimycin|Drug: lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate|Drug: basic treatment
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 520
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Fever to normal time (day)|Pulmonary inflammation resolution time (HRCT) (day)|Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment
|
NCT05005312
|
Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332 |
Completed |
Phase 1 |
Aug/31/2021 |
Dec/07/2021 |
- Alternative id - C4671010
- Interventions - Drug: PF-07321332|Drug: Ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations - Orange County Research Center, Tustin, California, United States|Prism Research LLC dba Nucleus Network, Saint Paul, Minnesota, United States
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 17
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Maximum observed plasma concentration (Cmax) for PF-07321332|Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Last Measurable Time (AUClast) for PF-07321332|Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-07321332|Incidence of Treatment Emergent Adverse Events|Incidence of Abnormal ECGs|Incidence of Abnormal Vital Signs|Incidence of Abnormal Laboratory Values
|
NCT05263908
|
General Investigation for PAXLOVID PACK |
Not yet recruiting |
|
Mar/01/2022 |
Jul/10/2023 |
- Alternative id - C4671018
- Interventions - Drug: nirmatrelvir / ritonavir
- Study type - Observational
- Study results - No Results Available
- Locations - Pfizer Local County, Tokyo, Japan
- Study designs - Observational Model: Case-Only|Time Perspective: Prospective
- Enrollment - 3300
- Age - 12 Years and older (Child, Adult, Older Adult)
- Outcome measures - Incidence of adverse drug reactions|Ratio of subjects with worsening severity
|
NCT04255017
|
A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia |
Unknown status |
Phase 4 |
Feb/01/2020 |
Jul/01/2020 |
- Alternative id - TJ20200128
- Interventions - Drug: Abidol hydrochloride|Drug: Oseltamivir|Drug: Lopinavir/ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations - Department and Institute of Infectious Disease, Wuhan, Hubei, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
- Enrollment - 400
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Rate of disease remission|Time for lung recovery|Rate of no fever|Rate of respiratory symptom remission|Rate of lung imaging recovery|Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery|Rate of undetectable viral RNA
|
NCT04261270
|
A Randomized,Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia |
Unknown status |
Phase 3 |
Feb/01/2020 |
Jul/01/2020 |
- Alternative id - ASC09F-CTP-TJ-01
- Interventions - Drug: ASC09F+Oseltamivir|Drug: Ritonavir+Oseltamivir|Drug: Oseltamivir
- Study type - Interventional
- Study results - No Results Available
- Locations - Department and Institute of Infectious Disease, Wuhan, Hubei, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
- Enrollment - 60
- Age - 18 Years to 55 Years (Adult)
- Outcome measures - Rate of comprehensive adverse outcome|Time of clinical remission|Rate of no fever|Rate of no cough|Rate of no dyspnea|Rate of no need for oxygen inhalation|Rate of undetectable viral RNA|Rate of mechanical ventilation|Rate of ICU admission|Rate and time of CRP,ES,Biochemical criterion(CK,ALT,Mb)recovery
|
NCT04499677
|
FLARE: Favipiravir +/- Lopinavir: A RCT of Early Antivirals |
Completed |
Phase 2 |
Sep/24/2020 |
Dec/01/2021 |
- Alternative id - 132084
- Interventions - Drug: Favipiravir|Drug: Lopinavir/ Ritonavir|Other: Favipiravir Placebo|Other: Lopinavir/ Ritonavir Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Royal Free Hospital, London, United Kingdom|University College London Hospital (UCLH), London, United Kingdom
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 240
- Age - 18 Years to 70 Years (Adult, Older Adult)
- Outcome measures - Upper respiratory tract viral load at Day 5|Percentage of participants with undetectable upper respiratory tract viral load after 5 days of therapy|Proportion of participants with undetectable stool viral load after 7 days of therapy.|Rate of decrease in upper respiratory tract viral load during 7 days of therapy|Duration of fever following commencement of medication|Proportion of participants with hepatotoxicity after 7 days of therapy|Proportion of participants with other medication-related toxicity after 7 days of therapy and 14 days post-randomisation|Proportion of participants admitted to hospital with COVID-19 related illness|Proportion of participants admitted to ICU with COVID-19 related illness|Proportion of participants who have died with COVID-19 related illness|Pharmacokinetics of favipiravir as measured by Clearance (CL)|Pharmacokinetics of favipiravir as measured by Volume of distribution (V)|Pharmacokinetics of favipiravir as measured by Absorption rate constant (Ka)|Pharmacokinetics of favipiravir as measured by Maximum concentration (Cmax)|Pharmacokinetics of favipiravir as measured by Time to maximum concentration (Tmax)|Pharmacokinetics of favipiravir as measured by Elimination rate constant (Ke)|Pharmacokinetics of favipiravir as measured by Area Under the Curve extrapolated to infinity (AUC (0-inf)|Pharmacodynamics of favipiravir as measured by Rate of viral load decline (delta)|Pharmacodynamics of favipiravir as measured by Maximum increase in viral load under drug treatment (Emax)|Pharmacodynamics of favipiravir as measured by Concentration to achieve half the maximum possible effect (EC50)|Proportion of participants with deleterious or resistance-conferring mutations in SARS-CoV-2 by Day 7 of treatment
|
NCT05263895
|
Relative Bioavailability Study of 4 Different Formulations of PF-07321332 Relative to the Commercial Tablet Formulation |
Not yet recruiting |
Phase 1 |
Mar/03/2022 |
May/14/2022 |
- Alternative id - C4671008
- Interventions - Drug: PF-07321332/ritonavir|Drug: PF-07321332
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 12
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Area under the Concentration-Time Curve (AUC)|Maximum Observed Plasma Concentration (Cmax)|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)|Number of Participants With Notable Electrocardiogram (ECG) Values|Number of Participants With Clinically Notable Vital Signs|Number of Participants With Clinically Notable Changes in Clinical laboratory|Number of Participants With Clinically Notable Abnormality in physical examination
|
NCT05263921
|
Relative Bioavailability Study of PF-07321332/Ritonavir Oral Powder Relative to the Commercial Tablets in Healthy Participants |
Not yet recruiting |
Phase 1 |
Mar/11/2022 |
May/18/2022 |
- Alternative id - C4671024
- Interventions - Drug: PF-07321332/ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 12
- Age - 18 Years to 60 Years (Adult)
- Outcome measures - Area under curve from time zero to 72 hours post dose|Peak plasma concentration (Cmax)|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)|Number of Participants With Notable Electrocardiogram (ECG) Values|Number of Participants With Clinically Notable Vital Signs|Number of Participants With Clinically Notable Changes in Clinical laboratory|Number of Participants With Clinically Notable Abnormality in physical examination|Palatability assessment of PF-07321332/ritonavir oral powder mixed with water/applesauce/vanilla pudding
|
NCT04459702
|
A Study of Combination Therapies to Treat COVID-19 Infection |
Withdrawn |
Phase 2 |
Jul/01/2020 |
Dec/01/2021 |
- Alternative id - PRG-043
- Interventions - Drug: hydroxychloroquine|Drug: Azithromycin|Drug: Ritonavir|Drug: Lopinavir
- Study type - Interventional
- Study results - No Results Available
- Locations - ProgenaBiome, Ventura, California, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 0
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores|Efficacy of Treatment by Time to Non-Infectivity|Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores|Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores.|Safety of Dual Therapy as Measured by Complete Blood Count|Safety of Quadruple Therapy as Measured by Complete Blood Count|Safety of Dual Therapy as Measured by Metabolic Panel -Albumin|Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin|Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio|Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio|Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase|Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase|Safety of Dual Therapy as Measured by Metabolic Panel - AST|Safety of Quadruple Therapy as Measured by Metabolic Panel - AST|Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT|Safety of Dual Therapy as Measured by Metabolic Panel ALT|Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio|Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio|Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN|Safety of Dual Therapy as Measured by Metabolic Panel - BUN|Safety of Dual Therapy as Measured by Metabolic Panel - Calcium|Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium|Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide|Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide|Safety of Dual Therapy as Measured by Metabolic Panel - Chloride|Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride|Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine|Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine|Safety of Dual Therapy as Measured by Metabolic Panel - Globulin|Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin|Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose|Safety of Dual Therapy as Measured by Metabolic Panel - Glucose|Safety of Dual Therapy as Measured by Metabolic Panel - Potassium|Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium|Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin|Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin|Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein|Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein|Safety of Dual Therapy as Measured by Treatment Related SAE|Safety of Quadruple Therapy as Measured by Treatment Related SAE
|
NCT04390152
|
Safety and Efficacy of Intravenous Wharton's Jelly Derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Due to COVID 19 |
Recruiting |
Phase 1|Phase 2 |
Jan/13/2020 |
Apr/01/2022 |
- Alternative id - BIOXSOMCOV001
- Interventions - Drug: Wharton's jelly derived Mesenchymal stem cells.|Drug: Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy)
- Study type - Interventional
- Study results - No Results Available
- Locations - BioXcellerator, Medellin, Antioquia-CO, Colombia|Clinical Somer, Rionegro, Antioquia, Colombia
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 40
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - Intergroup mortality difference with treatment|Number of patients with treatment related adverse events|Difference in days of mechanical ventilation between groups|Median reduction of days of hospitalization|Median reduction of days of oxygen needs|Difference between "Sequential Organ Failure Assessment" score between groups|Difference between median Murray score between groups|Difference in APACHE II score between groups|Difference in lymphocyte count between groups|Changes in C reactive protein concentration between groups|Changes in D dimer concentration|Changes in ferritin concentration|Changes in lactate dehydrogenase concentration|Impact on interleukin 6 concentrations between groups.|Impact on interleukin 8 concentrations between groups.|Impact on interleukin 10 concentrations between groups.|Impact on tumor necrosis factor alpha concentrations between groups.
|
NCT04321174
|
COVID-19 Ring-based Prevention Trial With Lopinavir/Ritonavir |
Active, not recruiting |
Phase 3 |
Apr/17/2020 |
Mar/31/2022 |
- Alternative id - CORIPREV-1
- Interventions - Drug: Lopinavir/ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations - St. Paul's Hospital, Vancouver, British Columbia, Canada|Sunnybrook Hospital, Toronto, Ontario, Canada|St. Michael's Hospital, Toronto, Ontario, Canada|Toronto General Hospital, Toronto, Ontario, Canada
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 123
- Age - 18 Months and older (Child, Adult, Older Adult)
- Outcome measures - Microbiologic evidence of infection|Adverse events|Symptomatic COVID-19 disease|Seropositivity|Days of hospitalization attributable to COVID-19 disease|Respiratory failure requiring ventilatory support attributable to COVID-19 disease|Mortality|Short-term psychological impact of exposure to COVID-19 disease|Long-term psychological impact of exposure to COVID-19 disease|Health-related quality of life
|
NCT04962022
|
Drug-Drug Interaction Study Assessing Effect of Itraconazole on PF-07321332/Ritonavir in Healthy Participants |
Completed |
Phase 1 |
Jul/20/2021 |
Sep/30/2021 |
- Alternative id - C4671015|2021-003308-42
- Interventions - Drug: PF-07321332/ritonavir|Drug: Itraconazole
- Study type - Interventional
- Study results - No Results Available
- Locations - Brussels Clinical Research Unit, Brussels, Bruxelles-capitale, Région DE, Belgium
- Study designs - Allocation: Non-Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 12
- Age - 18 Years to 60 Years (Adult)
- Outcome measures - Maximum Observed Plasma Concentration (Cmax) of PF-07321332/ritonavir when administered alone|Cmax of PF-07321332/ritonavir when administered with itraconazole|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332/ritonavir when administered alone|AUCinf of PF-07321332/ritonavir when administered with itraconazole|Assessment of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)|Assessment of Participants With Laboratory Abnormalities|Assessment of Participants With Vital Signs Abnormalities of PF-07321332/ritonavir|Assessment of Participants With Vital Signs Abnormalities of PF-07321332/ritonavir with itraconazole|Assessment of Abnormalities in Physical Examination (PE)|Assessment of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings of PF-07321332/ritonavir|Assessment of Participants with Clinically Significant ECG findings of PF-07321332/ritonavir with itraconazole
|
NCT05129475
|
Food Effect Study to Evaluate the Effect of High-Fat Meal on the Relative Bioavailability of PF-07321332 Boosted With Ritonavir in Healthy Adult Participants |
Completed |
Phase 1 |
Nov/12/2021 |
Jan/12/2022 |
- Alternative id - C4671019
- Interventions - Drug: PF-07321332/ritonavir|Drug: Ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations - New Haven Clinical Research Unit, New Haven, Connecticut, United States
- Study designs - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 12
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Maximum Observed Plasma Concentration (Cmax) of PF-07321332|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332|Area Under the Curve From Time Zero o Last quantifiable concentration (AUClast) of PF-07321332|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332|Plasma Decay Half-Life (t1/2) of PF-07321332|Apparent Oral Clearance (CL/F) of PF-07321332|Apparent Volume of Distribution (Vz/F) of PF-07321332|Number of Participants With Laboratory Abnormalities|Number of participants with Treatment-Emergent Adverse Events (TEAEs)|Number of Participants With Clinically Significant Change From Baseline in Vital Sign|Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
|
NCT05024006
|
Public Health Emergency: SOLIDARITY TRIAL Philippines |
Completed |
Not Applicable |
Apr/23/2020 |
Apr/17/2021 |
- Alternative id - SJREB-2020-20
- Interventions - Drug: Remdesivir|Drug: Hydroxychloroquine|Drug: Lopinavir / Ritonavir|Drug: Interferon beta-1a|Drug: Acalabrutinib
- Study type - Interventional
- Study results - No Results Available
- Locations - Baguio General Hospital, Baguio City, Benguet, Philippines|Cebu Doctor's University Hospital, Cebu City, Cebu, Philippines|Perpetual Succor Hospital Cebu, Cebu City, Cebu, Philippines|Vicente Sotto Memorial Medical Center, Cebu City, Cebu, Philippines|Southern Philippines Medical Center, Davao City, Davao, Philippines|West Visayas University Medical Center, Iloilo City, Iloilo, Philippines|Makati Medical Center, Makati City, Metro Manila, Philippines|Chinese General Hospital, Manila, Metro Manila, Philippines|Manila Doctors Hospital, Manila, Metro Manila, Philippines|ManilaMed - Medical Center Philippines, Manila, Metro Manila, Philippines|San Lazaro Hospital, Manila, Metro Manila, Philippines|UP - Philippine General Hospital, Manila, Metro Manila, Philippines|Asian Hospital and Medical Center, Muntinlupa, Metro Manila, Philippines|Research Institute for Tropical Medicine, Muntinlupa, Metro Manila, Philippines|San Juan de Dios Educational Foundation Inc - Hospital, Pasay, Metro Manila, Philippines|The Medical City, Pasig City, Metro Manila, Philippines|Diliman Doctors Hospital, Quezon City, Metro Manila, Philippines|Fe Del Mundo Medical Center, Quezon City, Metro Manila, Philippines|Lung Center of the Philippines, Quezon City, Metro Manila, Philippines|St Luke's Medical Center Quezon City, Quezon City, Metro Manila, Philippines|University of the East Ramon Magsaysay Memorial Medical Center, Quezon City, Metro Manila, Philippines|World Citi Medical Center, Quezon City, Metro Manila, Philippines|Cardinal Santos Medical Center, San Juan, Metro Manila, Philippines|St Luke's Medical Center Global, Taguig, Metro Manila, Philippines|Batangas Medical Center, Batangas, Philippines
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 1314
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - All-cause mortality|Duration of hospital stay|Time to first receiving ventilation
|
NCT04307693
|
Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19) |
Terminated |
Phase 2 |
Mar/11/2020 |
Apr/30/2020 |
- Alternative id - S2020-0472-0001
- Interventions - Drug: Lopinavir/ritonavir|Drug: Hydroxychloroquine sulfate
- Study type - Interventional
- Study results - No Results Available
- Locations - Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 65
- Age - 16 Years to 99 Years (Child, Adult, Older Adult)
- Outcome measures - Viral load|Viral load change|Time to clinical improvement (TTCI)|Percentage of progression to supplemental oxygen requirement by day 7|Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7|Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission|Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7|adverse effects|Concentration of Lopinavir/ritonavir and hydroxychloroquine
|
NCT04403100
|
Hydroxychloroquine and Lopinavir/ Ritonavir to Improve the Health of People With COVID-19: "The Hope Coalition - 1" |
Recruiting |
Phase 3 |
Jun/03/2020 |
Feb/01/2021 |
- Alternative id - COVID19_AMB_Brasil
- Interventions - Drug: Hydroxychloroquine Sulfate Tablets|Drug: Lopinavir/ Ritonavir Oral Tablet|Drug: Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - CARDRESEARCH - Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Minas Gerais, Brazil|Pontificia Universidade Catolica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil|Fundo Municipal de Saúde de Betim, Betim, Minas Gerais, Brazil|Universidade Federal de Ouro Preto, Ouro Preto, Minas Gerais, Brazil
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 1968
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Proportion of participants who were hospitalized for progression of COVID-19 disease|Proportion of participants who died due to COVID-19 progression and/ or complications|Proportion of participants with viral load change on 03, 07, 10 and 14 after randomization|Time to clinical improvement|Time to clinical failure|Hospitalization for any cause|Proportion of participants who died due to pulmonary complications|Proportion of participants who died due to cardiovascular complications|Proportion of participants who presented with adverse events|Time to improvement on respiratory scale symptoms|proportion of non-adherent participants to any of study drugs
|
NCT04394182
|
Ultra Low Doses of Therapy With Radiation Applicated to COVID-19 |
Recruiting |
Not Applicable |
Apr/21/2020 |
Apr/21/2021 |
- Alternative id - 20.4.1597-GHM
- Interventions - Radiation: Ultra-Low-dose radiotherapy|Device: ventilatory support with oxygen therapy|Drug: Lopinavir/ritonavir|Drug: Hydroxychloroquine|Drug: Azithromycin|Drug: Piperacillin/tazobactam|Drug: Low molecular weight heparin|Drug: Corticosteroid injection|Drug: Tocilizumab
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital La Milagrosa, GenesisCare, Madrid, Spain|Hospital Vithas Valencia Consuelo, Valencia, Spain
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Supportive Care
- Enrollment - 15
- Age - 18 Years to 120 Years (Adult, Older Adult)
- Outcome measures - Oxygen Therapy Status at Day 2|Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 2|Blood Gas Analysis at Day 2|Blood Test at Day 2|Oxygen Therapy Status at Day 5|Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 5|Blood Test at Day 5|Oxygen Therapy Status at Day 7|Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 7|Blood Test at Day 7|Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan at Day 7|Recovery time|COVID-19 status|Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan al Month 1|Acute Toxicity
|