Other substances

Nirmatrelvir

A 3C-like protease inhibitor.

Phase of research

Emergency use authorization

How it helps

Antiviral

Drug status

Experimental

Supporting references

Contradictory references

AI-suggested references

Clinical trials

General information

Nirmatrelvir is an orally bioavailable SARS-CoV-2 3C-like protease inhibitor. It is a derivative of PF-00835231. Nirmatrelvir reversibly binds to a cysteine residue in the catalytic core of the protease. Ritonavir was shown to significantly boost its therapeutic concentration (Owen et al., 2021).

A therapy using nirmatrelvir combined with ritonavir (co-packaged and marketed under the name Paxlovid®), which was developed by Pfizer, was approved for the treatment of COVID-19 in the UK by MHRA, has been granted emergency use authorization by the FDA in the USA, and has been authorized for use in the EU by EMA. An interim analysis of a phase II/III clinical trial suggests a significant decrease in hospitalization among outpatients who have begun Paxlovid® treatment within up to 5 days of COVID-19 symptoms’ onset (Mahase, 2021).

Nirmatrelvir on PubChem
Nirmatrelvir on DrugBank
Nirmatrelvir on Wikipedia

Synonyms

PF-07321332; Compound 6; 2628280-40-8; PF-332

Marketed as

PAXLOVID (co-packaged with ritonavir)

CC1([C@@H]2[C@H]1[C@H](N(C2)C(=O)[C@H](C(C)(C)C)NC(=O)C(F)(F)F)C(=O)N[C@@H](C[C@@H]3CCNC3=O)C#N)C

Supporting references

Link	Tested on	Impact factor	Notes	Publication date
Crystal structure of SARS-CoV-2 main protease in complex with protease inhibitor PF-07321332 3CLpro Crystallization Small molecule In vitro	In vitro	14.87	In a co-crystallization study, the drug was observed to covalently bind the gamma sulphur atom of C145 of SARS-CoV-2 3C-like protease. C145 represents the catalytically active site of the enzyme. Results support a model of a reversible linkage.	Oct/22/2021
An oral SARS-CoV-2 Mpro inhibitor clinical candidate for the treatment of COVID-19 3CLpro Crystallization Novel compound Biophysical assay Small molecule Enzyme assay Animal model In vitro Mechanism Phase I clinical trial Randomized controlled double-blind trial	Crystallization; Biophysical assay; Enzyme assay; Vero E6 cells; hACE2-A549 cells; dNHBE cells; Vero76 cells; BALB/c mice; SD rats and Cynomolgus monkeys (metabolic studies); SARS-CoV-2 MA10 (mouse-adapted); healthy adults; SARS-CoV-2 (USA_WA1/2020)	47.73	The drug was safe and reached blood concentrations expected to inhibit SARS-CoV-2. It inhibited SARS-CoV-2 3C-like protease and viral replication (with an EC50 of ca. 77.9 nM or lower) in vitro. Nirmatrelvir prevented infection-related weight loss and significantly reduced viral titres in murine lungs. The viral replication was reduced in a dose-dependent fashion. Ritonavir was shown to significantly boost nirmatrelvir’s therapeutic concentration. The drug combination was shown to be safe.	Nov/02/2021
Remdesivir, Molnupiravir and Nirmatrelvir remain active against SARS-CoV-2 Omicron and other variants of concern 3CLpro RdRpol Spike variant Small molecule In vitro	Vero E6(-GFP) cells; SARS-CoV-2 (various strains)	5.97	The compound retains its anti-SARS-CoV-2 activity in vitro against strains Alpha, Beta, Gamma, Delta, and Omicron.	Jan/24/2021
SARS-CoV-2 Omicron variant is highly sensitive to molnupiravir, nirmatrelvir, and the combination 3CLpro RdRpol Spike variant Small molecule In vitro	Calu-3 cells; human airway organoids; SARS-CoV-2 (strains: BetaCoV/Munich/BavPat1/2020; Delta; and Omicron)	25.62	The compound inhibited SARS-CoV-2 Omicron variant in Calu-3 cells in a dose-dependent manner with an IC50 of 0.02462 μM μM. Nirmatrelvir displayed synergy with molnupiravir against the Omicron strain. Nirmatrelvir was also active against the Delta variant.	Jan/20/2022
The oral protease inhibitor (PF-07321332) protects Syrian hamsters against infection with SARS-CoV-2 variants of concern 3CLpro Spike variant Small molecule Animal model In vitro	Vero E6 cells; A549-Dual™ hACE2-TMPRSS2 cells; primary human airway epithelial cells; Syrian Golden hamsters; SARS-CoV-2 (wild-type, Alpha, Beta, Gamma, and Delta variants)	14.92	The compound inhibited SARS-CoV-2 variants of concern with EC50s in the range of 70 to 280 nM in vitro. At 1 µM is completely inhibited the virus in primary human airway epithelial cells. It protected hamsters in a viral challenge by Beta and Delta variants (prevention of weight loss, reduction of lung pathology and viral titres, prevention of viral transmission).	Feb/15/2022
Efficacy of Licensed Monoclonal Antibodies and Antiviral Agents against the SARS-CoV-2 Omicron Sublineages BA.1 and BA.2 Spike protein 3CLpro RdRpol Spike variant Protein factor Small molecule In vitro Antibody	Vero E6 cells; SARS-CoV-2 live virus (strains B.1 (D614G) wild type, Delta, and Omicron BA.1 and BA.2)	5.05	The compound did not display significant inter-variant difference in its in vitro anti-SARS-CoV-2 activity – it was active.	Jun/23/2022
Characterization and antiviral susceptibility of SARS-CoV-2 Omicron BA.2 3CLpro Spike variant Protein factor Small molecule Animal model In vitro Antibody	VeroE6/TMPRSS2 cells; Syrian hamsters (K18-hACE2 lines); K18-hACE2 C57BL/6J mice; BALB/c mice; SARS-CoV-2 live virus (D614G, Delta, Omicron BA.1, Omicron BA.1.1, and Omicron BA.2 (various isolates))	49.96	The drug significantly decreased viral replication (BA.2 strain) in lungs and nasal turbinates of Syrian hamsters upon a viral challenge.	May/16/2022
Different efficacies of neutralizing antibodies and antiviral drugs on SARS-CoV-2 Omicron subvariants, BA.1 and BA.3 3CLpro Spike variant In vitro Antibody Small molekule	VeroE6/TMPRSS2 cells		The compound displayed anti-SARS-CoV-2 Omicron activity in vitro.	Jul/04/2022

AI-suggested references

Link	Publication date
Molnupiravir and Nirmatrelvir-Ritonavir: Oral COVID Antiviral Drugs.	May/03/2022
Characterization and antiviral susceptibility of SARS-CoV-2 Omicron/BA.2.	May/08/2020
Disposition of PF-07321332 (Nirmatrelvir), an Orally Bioavailable Inhibitor of SARS-CoV-2 3CL Protease, across Animals and Humans.	Jan/20/2022
Potential Resistance of SARS-CoV-2 Main Protease (Mpro) against Protease Inhibitors: Lessons Learned from HIV-1 Protease.	Sep/02/2020
Computational simulations on the binding and reactivity of a nitrile inhibitor of the SARS-CoV-2 main protease.	Oct/08/2021
[Nirmatrelvir plus ritonavir (Paxlovid) a potent SARS-CoV-2 3CLpro protease inhibitor combination].	Feb/19/2021
PF-07321332 (Nirmatrelvir) Does Not Interact with Human ENT1 or ENT2: Implications for COVID-19 Patients.	May/16/2022
Progress and Challenges in Targeting the SARS-CoV-2 Papain-like Protease.	May/27/2022
SARS-CoV-2 Permissive glioblastoma cell line for high throughput antiviral screening.	Mar/17/2022
Mass Spectrometric Assays Reveal Discrepancies in Inhibition Profiles for the SARS-CoV-2 Papain-Like Protease	Feb/17/2022
Computer Aided Drug Design Approach to Screen Phytoconstituents of Adhatoda vasica as Potential Inhibitors of SARS-CoV-2 Main Protease Enzyme	Feb/20/2022
Computational Screening of Phenylamino-Phenoxy-Quinoline Derivatives against the Main Protease of SARS-CoV-2 Using Molecular Docking and the ONIOM Method	Sep/22/2021
Structural basis for the in vitro efficacy of nirmatrelvir against SARS-CoV-2 variants	Apr/22/2022
Exploring the Binding Mechanism of PF-07321332 SARS-CoV-2 Protease Inhibitor through Molecular Dynamics and Binding Free Energy Simulations	Aug/24/2021
Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19	Mar/02/2022
RNAi to treat SARS-CoV-2:variant proofing the next generation of therapies	Mar/25/2021
Supervised Molecular Dynamics (SuMD) Insights into the mechanism of action of SARS-CoV-2 main protease inhibitor PF-07321332	Jul/23/2021
Synthesis of Nucleoside-like Molecules from a Pyrolysis Product of Cellulose and Their Computational Prediction as Potential SARS-CoV-2 RNA-Dependent RNA Polymerase Inhibitors	Aug/21/2021
In silico study of natural compounds from sesame against COVID-19 by targeting Mpro, PLpro and RdRp	Jun/24/2021
Innovative Randomized Phase I Study and Dosing Regimen Selection to Accelerate and Inform Pivotal COVID-19 Trial of Nirmatrelvir	Aug/04/2020
Oral Nirmatrelvir/Ritonavir Therapy for COVID-19: The Dawn in the Dark?	Feb/09/2022
Main protease mutants of SARS-CoV-2 variants remain susceptible to nirmatrelvir	Feb/16/2022
First-generation Oral Antivirals Against SARS-CoV-2.	May/08/2022
In silico evidence of antiviral activity against SARS-CoV-2 main protease of oligosaccharides from Porphyridium sp.	Mar/25/2021
GC-MS, LC-MS/MS, Docking and Molecular Dynamics Approaches to Identify Potential SARS-CoV-2 3-Chymotrypsin-Like Protease Inhibitors from Zingiber officinale Roscoe	Aug/28/2021
Covalent narlaprevir- and boceprevir-derived hybrid inhibitors of SARS-CoV-2 main protease	Apr/27/2022
New chalcone derivatives as effective against SARS-CoV-2 agent	Sep/25/2021
Nirmatrelvir Plus Ritonavir: First Approval	Mar/20/2022
Insights into the binding and covalent inhibition mechanism of PF-07321332 to SARS-CoV-2 Mpro.	Jan/28/2022
Structural Basis of the Main Proteases of Coronavirus Bound to Drug Candidate PF-07321332	Mar/31/2020
Design, Synthesis and In Vitro Experimental Validation of Novel TRPV4 Antagonists Inspired by Labdane Diterpenes	Mar/31/2022
2-((1H-indol-3-yl)thio)-N-phenyl-acetamides: SARS-CoV-2 RNA-dependent RNA polymerase inhibitors.	Nov/18/2021
Novel Nitrile Peptidomimetics for Treating COVID-19.	Feb/03/2022
Characterization of the non-covalent interaction between the PF-07321332 inhibitor and the SARS-CoV-2 main protease	Sep/30/2020
Identification of Mpro inhibitors of SARS-CoV-2 using structure based computational drug repurposing.	Oct/01/2021
Early clinical experience with nirmatrelvir/ritonavir for the treatment of COVID-19 in solid organ transplant recipients	Dec/03/2021
Reproductive and developmental safety of nirmatrelvir (PF-07321332), an oral SARS-CoV-2 Mpro inhibitor in animal models	Apr/30/2022
Discovery of a new generation of angiotensin receptor blocking drugs: receptor mechanisms and in silico binding to enzymes relevant to covid-19.	Apr/09/2022
Emerging small molecule antivirals may fit neatly into COVID-19 treatment	Oct/19/2021
A VSV-based assay quantifies coronavirus Mpro/3CLpro/Nsp5 main protease activity and chemical inhibition	Jan/28/2022
Comprehensive Nonclinical Safety Assessment of Nirmatrelvir Supporting Timely Development of the SARS-COV-2 Antiviral Therapeutic, Paxlovid	May/21/2022
Pro108Ser mutation of SARS-CoV-2 3CLpro reduces the enzyme activity and ameliorates the clinical severity of COVID-19	Dec/17/2020

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
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
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
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
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)
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)
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
NCT05178654	Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]PF-07321332 in Healthy Male Participants.	Withdrawn	Phase 1	Feb/22/2022	Apr/01/2022
Alternative id - C4671007 Interventions - Drug: [14C]PF-07321332 Study type - Interventional Study results - No Results Available Locations - Study designs - Allocation: Randomized\|Intervention Model: Single Group Assignment\|Masking: None (Open Label)\|Primary Purpose: Basic Science Enrollment - 0 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Cumulative amount of radioactivity Recovered in Urine (Ae)\|Cumulative amount of radioactivity Recovered in Feces (Ae)\|Metabolic Profiling in blood\|Metabolic Profiling in Urine\|Metabolic Profiling in Feces\|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 Clinical Chemistry/Biochemistry Shifts Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade
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
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
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

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