NCT05059080
|
A Six-Month Follow-Up Study of Participants With Coronavirus Disease 2019 (COVID-19) Previously Enrolled in a RO7496998 (AT-527) Study |
Active, not recruiting |
|
Jun/15/2021 |
Mar/14/2022 |
- Alternative id - CV43140|2021-000627-12
- Interventions -
- Study type - Observational
- Study results - No Results Available
- Locations - Instituto Ave Pulmo, Mar Del Plata, Argentina|Private Practice Dr Jean Benoit Martinot, Erpent, Belgium|Medif, Gozée, Belgium|L2IP -Instituto de Pesquisas Clínicas Ltda., Brasilia, DF, Brazil|Chronos Pesquisa Clinica, Taguatinga, DF, Brazil|Hospital Agamenon Magalhães, Recife, PE, Brazil|Conjunto Hospitalar do Mandaqui, Sao Paulo, SP, Brazil|Aalborg Universitetshospital, Aalborg, Denmark|Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark|Sjællands Universitetshospital, Roskilde, Roskilde, Denmark|Praxis am Ebertplatz, Köln, Germany|CIMAB SA de CV, Torreón, Coahuila, Mexico|Panamerican Clinical Research S.A de C.V., Guadalajara, Jalisco, Mexico|Clinstile S.A de C.V., Mexico City, Mexico CITY (federal District), Mexico|PanAmerican Clinical Research, Querétaro, Queréaro, Queretaro, Mexico|Instituto Jalisciense de Investigacion Clinica S.A. de C.V., Guadalajara, Mexico|Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico, Mexico|Hospital Senhora da Oliveira - Guimaraes, E.P.E, Guimarães, Portugal|Centro Hospitalar de Leiria (CHL), Leiria, Portugal|Unidade Local de Saude de Matosinhos SA, Matosinhos, Portugal|Prof. Dr. Matei Bals Institute of Infectious Diseases, Bucuresti, Romania|County Hospital Caracal, Caracal, Romania|Sibiu Emergency Clinical County Hospital, Sibiu, Romania|Gazi Universitesi Tip Fakultesi, Ankara, Turkey|Hacettepe University Medical Faculty, Ankara, Turkey|Koc University Medical Faculty Hospital, Istanbul, Turkey|Ege University Medical Faculty, Izmir, Turkey|Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey|Ankara University Medical Faculty - PPDS, Çankaya, Turkey|Istanbul University Cerrahpasa Medical Faculty Hospital; Tesvikiye Caddesi No:20, Şi̇şli̇, Turkey|Municipal Non-profit enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council, Ivano-Frankivsk, Katerynoslav Governorate, Ukraine|Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council, Kharkiv, Kharkiv Governorate, Ukraine|Public Non-Profit Enterprise "City Outpatient Clinic #9" of Kharkiv City Council, Kharkiv, Kharkiv Governorate, Ukraine|CNPE City Clinical Hospital #6 of DCC, Dnipro, Kholm Governorate, Ukraine|Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council, Dnipro, KIEV Governorate, Ukraine|CNPE Ivano-Frankivsk Regional Centre of Phthisiology and Pulmonology of IFRC, Ivano Frankivsk, KIEV Governorate, Ukraine|Medical Center LLC "Harmony of Beauty", Kyiv, KIEV Governorate, Ukraine|CNE Kyiv City Clinical Hospital#1 of Exec. Body, Kyiv, KIEV Governorate, Ukraine|Medical Center of LLC Preventclinic, Kyiv, KIEV Governorate, Ukraine|Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail, Kyiv, KIEV Governorate, Ukraine|Polyclinic of Center of Medical Service and Rehabilitation of State JSHC Artem, Kyiv, KIEV Governorate, Ukraine|Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1, Vinnytsya, Podolia Governorate, Ukraine|Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council, Zaporizhzhia, Tavria Okruha, Ukraine|Private Enterprise Private Manufacturing Company Acinus, Kirovograd, Ukraine
- Study designs - Observational Model: Cohort|Time Perspective: Prospective
- Enrollment - 73
- Age - 12 Years and older (Child, Adult, Older Adult)
- Outcome measures - COVID-19 Symptoms Assessment through the COVID-19 Symptom Diary (Items 1-14)|Dyspnea Symptoms Assessment through the Patient Reported Outcomes Measurement Information System (PROMIS) - Dyspnea Questionnaire|Respiratory Symptoms Assessment through the St. George's Respiratory Questionnaire (SGRQ)|Proportion of Participants with COVID-19 Related Medically-Attended Visits|Proportion of Participants with Death Attributable to Progression of COVID-19|Proportion of Participants Re-Infected with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)|Proportion of Participants with any Post-Treatment Infection|Frequency of COVID-19 Related Complications|Proportion of Participants with Adverse Events (AEs) and Serious AEs (SAEs)
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NCT04877769
|
Bronchopulmonary PK of AT-527 (R07496998) |
Completed |
Phase 1 |
Apr/25/2021 |
Aug/31/2021 |
- Alternative id - AT-03A-007
- Interventions - Drug: AT-527
- Study type - Interventional
- Study results - No Results Available
- Locations - Atea Study Site, London, United Kingdom
- Study designs - Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 24
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - Concentrations of AT-527 in epithelial lining fluid
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NCT05126576
|
Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19 |
Suspended |
Phase 3 |
Apr/28/2021 |
Nov/17/2021 |
- Alternative id - CV43043|2020-005759-18
- Interventions - Drug: RO7496998|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Instituto Medico Rio Cuarto, Cordoba, Argentina|Instituto Ave Pulmo, Mar Del Plata, Argentina|Clínica Independencia, Munro, Argentina|Instituto Medico de la Fundacion Estudios Clinicos, Rosario, Argentina|Clinica Mayo de U.M.C.B. S.R.L, San Miguel de Tucumán, Argentina|Sanatorio Medico de Diagnostico Y Tratamiento, Santa Fe, Argentina|Maison Médicale La Brèche, Châtelineau, Belgium|Private Practice Dr Jean Benoit Martinot, Erpent, Belgium|Medif, Gozée, Belgium|L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar, Brasilia, DF, Brazil|Chronos Pesquisa Clinica, Taguatinga, DF, Brazil|Hospital das Clinicas - UFMG, Belo Horizonte, MG, Brazil|Hospital Agamenon Magalhães, Recife, PE, Brazil|Hospital Nossa Senhora das Graças, Curitiba, PR, Brazil|Hospital Erasto Gaertner, Curitiba, PR, Brazil|Hospital E Maternidade Celso Pierro PUCCAMP, Campinas, SP, Brazil|Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS, Sao Jose Do Rio Preto, SP, Brazil|CPQuali Pesquisa Clínica Sao Paulo, Sao Paulo, SP, Brazil|Institute of Infectious Diseases Emilio Ribas, Sao Paulo, SP, Brazil|Conjunto Hospitalar do Mandaqui, Sao Paulo, SP, Brazil|Aalborg Universitetshospital, Aalborg, Denmark|Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark|Sjællands Universitetshospital, Roskilde, Roskilde, Denmark|Centre Hospitalier Victor Dupouy, Argenteuil, France|Hôpital Saint Joseph, Marseille, France|Hopital Tenon, Paris, France|Klinikum Chemnitz gGmbH, Chemnitz, Germany|Universitätsklinikum Frankfurt, Frankfurt, Germany|Universitätsklinikum Freiburg, Freiburg, Germany|Praxis am Ebertplatz, Köln, Germany|ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco, Lecco, Lombardia, Italy|Ospedale San Raffaele S.r.l., Milano, Lombardia, Italy|Comprensorio Amedeo Di Savoia Birago Di Vische, Torino, Piemonte, Italy|Funabashi Central Hospital, Funabashi-Shi, Japan|Higashiosaka city Medical Center, Higashiosaka-Shi, Japan|Rinku General Medical Center, Izumisano, Japan|Sagamihara Kyodo Hospital, Kanagawa, Japan|Misyuku hospital, Meguro-Ku, Japan|Nagoya City East Medical Center, Nagoya-Shi Chikusa-Ku, Japan|Fujita Health University Banbuntane Hotokukai Hospital, Nagoya-shi, Japan|Tokyo Metropolitan Police Hospital, Nakano-Ku, Japan|IUHW Narita Hospital, Narita, Japan|Houjin Syadan Kouhoukai Takagi Hospital, Okawa-Shi, Japan|Okayama City Hospital, Okayama, Japan|Ome Municipal General Hospital, Ome-Shi, Japan|Osaka City General Hospital, Osaka, Japan|National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai-shi, Japan|Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai, Shinagawa, Japan|St. Luke's International Hospital, Tokyo, Japan|Edogawa Medicare Hospital, Tokyo, Japan|Center Hospital of the National Center for Global Health and Medicine, Tokyo, Japan|JCHO Tokyo Shinjuku Medical Center, Tokyo, Japan|Tokyo Medical University Hachioji Medical Center, Tokyo, Japan|National Hospital Organization Kasumigaura Medical Center, Tsuchiurat, Japan|Mie Prefectural Medical Centre, Yokkaichi, Japan|CIMAB SA de CV, Torreón, Coahuila, Mexico|Panamerican Clinical Research S.A de C.V., Guadalajara, Jalisco, Mexico|Clinstile S.A de C.V., Mexico City, Mexico CITY (federal District), Mexico|PanAmerican Clinical Research, Querétaro, Queréaro, Queretaro, Mexico|Instituto Jalisciense de Investigacion Clinica S.A. de C.V., Guadalajara, Mexico|Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico, Mexico|CEPREP; Hospital Universitario, Monterrey, Mexico|Hospital Senhora da Oliveira - Guimaraes, E.P.E, Guimarães, Portugal|Centro Hospitalar de Leiria (CHL), Leiria, Portugal|Unidade Local de Saude de Matosinhos SA, Matosinhos, Portugal|Prof. Dr. Matei Bals Institute of Infectious Diseases, Bucuresti, Romania|County Hospital Caracal, Caracal, Romania|Sibiu Emergency Clinical County Hospital, Sibiu, Romania|Dr. Victor Babes Clinical Hospital of Pneumophthisiology and Infectious Diseases, Timişoara, Romania|Dr JM Engelbrecht Trial site, Cape Town, South Africa|TASK Eden, George, South Africa|Langeberg Clinical Trials, Kraaifontein, South Africa|Clinical Projects Research, Worcester, South Africa|Hôpital Universitaire de Genève (HUG), Genève, Switzerland|Universitätsspital Zürich, Zürich, Switzerland|Gazi Universitesi Tip Fakultesi, Ankara, Turkey|Hacettepe University Medical Faculty, Ankara, Turkey|Koc University Medical Faculty Hospital, Istanbul, Turkey|Ege University Medical Faculty, Izmir, Turkey|Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey|Ankara University Medical Faculty - PPDS, Çankaya, Turkey|Istanbul University Cerrahpasa Medical Faculty Hospital; Tesvikiye Caddesi No:20, Şi̇şli̇, Turkey|Municipal Non-profit enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council, Ivano-Frankivsk, Katerynoslav Governorate, Ukraine|Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council, Kharkiv, Kharkiv Governorate, Ukraine|Public Non-Profit Enterprise "City Outpatient Clinic #9" of Kharkiv City Council, Kharkiv, Kharkiv Governorate, Ukraine|CNPE City Clinical Hospital #6 of DCC, Dnipro, Kholm Governorate, Ukraine|Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council, Dnipro, KIEV Governorate, Ukraine|CNPE Ivano-Frankivsk Regional Centre of Phthisiology and Pulmonology of IFRC, Ivano Frankivsk, KIEV Governorate, Ukraine|Private Enterprise Private Manufacture Company "Acinus", diagnostic and treatment center, Kirovograd, KIEV Governorate, Ukraine|Medical Center LLC "Harmony of Beauty", Kyiv, KIEV Governorate, Ukraine|CNE Kyiv City Clinical Hospital#1 of Exec. Body, Kyiv, KIEV Governorate, Ukraine|Medical Center of LLC Preventclinic, Kyiv, KIEV Governorate, Ukraine|Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail, Kyiv, KIEV Governorate, Ukraine|Polyclinic of Center of Medical Service and Rehabilitation of State JSHC Artem, Kyiv, KIEV Governorate, Ukraine|Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1, Vinnytsya, Podolia Governorate, Ukraine|Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council, Zaporizhzhia, Tavria Okruha, Ukraine
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 1386
- Age - 12 Years and older (Child, Adult, Older Adult)
- Outcome measures - Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 hours)|Time to Alleviation or Improvement of COVID-19 Symptoms (43 hours)|Time to Alleviation of COVID-19 Symptoms (21.5 hours)|Time to Alleviation of COVID-19 Symptoms (43 hours)|Time to One-Category Improvement of Baseline Presenting COVID-19 Symptoms|Time to Alleviation of Individual Symptoms|Proportion of Participants Requiring Hospitalization for COVID-19|Proportion of Participants with Greater than or Equal to 1 COVID-19 Related Medically Attended Visit|Duration of Fever|Frequency of COVID-19 Related Complications|Proportion of Participants with any Post-Treatment Infection|Change from Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA|Time to Cessation of SARS-CoV-2 Viral Shedding|Proportion of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints|Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA|Percentage of Participants with Adverse Events (AEs)|Plasma Concentration of AT-511, AT-551, AT-229 and AT-273 at Specified Timepoints
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NCT04709835
|
Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19 |
Completed |
Phase 2 |
Feb/03/2021 |
Oct/13/2021 |
- Alternative id - WV43042
- Interventions - Drug: AT-527|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Multiprofile Hospital for Active Treatment Puls AD PPDS, Blagoevgrad, Bulgaria|Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC, Gabrovo, Bulgaria|MHAT Dr. Atanas Dafovski AD, Kardzhali, Bulgaria|Multiprofile Hospital for Active Treatment - Prof. Dr. Paraskev Stoyanov AD, Lovech, Bulgaria|Medical center Medconsult Pleven OOD, Pleven, Bulgaria|University Multiprofile Hospital for Active Treatment Sveta Marina Pleven OOD, Pleven, Bulgaria|Multiprofile Hospital for Active Treatment Plovdiv, Plovdiv, Bulgaria|MHAT "Sv. Ivan Rilski" - Razgrad AD; Department of pnemology and phthisiatry, Razgrad, Bulgaria|Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr. D. Gramatikov - Ruse, Ruse, Bulgaria|Multiprofile Hospital for Active Treatment - Samokov EOOD, Samokov, Bulgaria|Diagnostic and Consulting Center Aleksandrovska EOOD, Sofia, Bulgaria|Diagnostic Consultative CTR XX Sofia EOOD, Sofia, Bulgaria|Multiprofile Hospital for Active Treatment (MHAT) - Targovishte, Targovishte, Bulgaria|Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada|Hamilton Medical Research Group, Hamilton, Ontario, Canada|Evangelismos General Hospital of Athens, Athens, Greece|Sotiria General Hospital of Athens; 3rd Department of Internal Medicine, Athens, Greece|National and Kapodistrian University of Athens, Athens, Greece|University General Hospital of Ioannina, Ioannina, Greece|General State Hospital of Nikaia St Panteleimon, Nikaia Attikis, Greece|Connolly Hospital, Dublin, Ireland|Private Practice of Dr Liga Kozlovska, Balvi, Latvia|RSU Ambulance, Riga, Latvia|Outpatient Clinic Alma, Rīga, Latvia|Outpatient Clinic Adoria, Rīga, Latvia|The Family Physician's Practice of Dr. Maija Kozlovska, Salaspils, Latvia|M & M Centrs, Ādaži, Latvia|UAB Inmedica, Kaunas, Lithuania|JSC Saules Family Health Center, Kaunas, Lithuania|Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania|Krakowskie Centrum Medyczne Sp. z o.o., Krakow, Poland|Centrum Medyczne Pulawska SP. z o.o., Piaseczno, Poland|Centralny Szpital Klinicznty MSWiA w Warszawie, Warszawa, Poland|Centrum Badań Klinicznych, Wrocław, Poland|Hospital El Pilar - Grupo Quirónsalud, Esplugues de Llobregat, Barcelona, Spain|Hospital Universitario Son Espases, Palma de Mallorca, Islas Baleares, Spain|Hospital Costa del Sol, Marbella, Malaga, Spain|Hospital Universitario La Paz - PPDS, Barcelona, Spain|Hospital Universitario Infanta Leonor, Madrid, Spain|Chapel Street Medical Centre, Ashton-under-Lyne, United Kingdom|Tower Family Healthcare - Moorgate Primary Care Ce, Bury, United Kingdom|CPS Research, Glasgow, United Kingdom|Chelsea and Westminster NHS Trust, London, United Kingdom
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 104
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Change from Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA|Time to Cessation of SARS-CoV-2 Viral Shedding|Time to Sustained Non-Detectable SARS-CoV-2 Virus RNA|Proportion of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints|Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA|Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 hours)|Time to Alleviation or Improvement of COVID-19 Symptoms (43 hours)|Time to Alleviation of COVID-19 Symptoms (21.5 hours)|Time to Alleviation of COVID-19 Symptoms (43 hours)|Duration of Fever|Frequency of COVID-19 Related Complications|Time to Alleviation of an Individual Symptom|Percentage of Participants with Adverse Events (AEs)|Plasma Concentration of AT-511, AT-551, AT-229 and AT-273
|
NCT04889040
|
Study to Evaluate the Effects of RO7496998 (AT-527) in Non-Hospitalized Adult and Adolescent Participants With Mild or Moderate COVID-19 |
Terminated |
Phase 3 |
Apr/28/2021 |
Nov/17/2021 |
- Alternative id - CV43043|2020-005759-18
- Interventions - Drug: RO7496998|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Instituto Medico Rio Cuarto, Cordoba, Argentina|Instituto Ave Pulmo, Mar Del Plata, Argentina|Clínica Independencia, Munro, Argentina|Instituto Medico de la Fundacion Estudios Clinicos, Rosario, Argentina|Clinica Mayo de U.M.C.B. S.R.L, San Miguel de Tucumán, Argentina|Sanatorio Medico de Diagnostico Y Tratamiento, Santa Fe, Argentina|Maison Médicale La Brèche, Châtelineau, Belgium|Private Practice Dr Jean Benoit Martinot, Erpent, Belgium|Medif, Gozée, Belgium|L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar, Brasilia, DF, Brazil|Chronos Pesquisa Clinica, Taguatinga, DF, Brazil|Hospital das Clinicas - UFMG, Belo Horizonte, MG, Brazil|Hospital Agamenon Magalhães, Recife, PE, Brazil|Hospital Nossa Senhora das Graças, Curitiba, PR, Brazil|Hospital Erasto Gaertner, Curitiba, PR, Brazil|Hospital E Maternidade Celso Pierro PUCCAMP, Campinas, SP, Brazil|Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS, Sao Jose Do Rio Preto, SP, Brazil|CPQuali Pesquisa Clínica Sao Paulo, Sao Paulo, SP, Brazil|Institute of Infectious Diseases Emilio Ribas, Sao Paulo, SP, Brazil|Conjunto Hospitalar do Mandaqui, Sao Paulo, SP, Brazil|Healthy Medical Center SAS, Zipaquirá, Colombia|Aalborg Universitetshospital, Aalborg, Denmark|Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark|Sjællands Universitetshospital, Roskilde, Roskilde, Denmark|Centre Hospitalier Victor Dupouy, Argenteuil, France|Hôpital Saint Joseph, Marseille, France|Hopital Tenon, Paris, France|Klinikum Chemnitz gGmbH, Chemnitz, Germany|Universitätsklinikum Frankfurt, Frankfurt, Germany|Universitätsklinikum Freiburg, Freiburg, Germany|Praxis am Ebertplatz, Köln, Germany|ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco, Lecco, Lombardia, Italy|Ospedale San Raffaele S.r.l., Milano, Lombardia, Italy|Comprensorio Amedeo Di Savoia Birago Di Vische, Torino, Piemonte, Italy|Funabashi Central Hospital, Funabashi-Shi, Japan|Higashiosaka city Medical Center, Higashiosaka-Shi, Japan|Rinku General Medical Center, Izumisano, Japan|Sagamihara Kyodo Hospital, Kanagawa, Japan|Misyuku hospital, Meguro-Ku, Japan|Nagoya City East Medical Center, Nagoya-Shi Chikusa-Ku, Japan|Fujita Health University Banbuntane Hotokukai Hospital, Nagoya-shi, Japan|Tokyo Metropolitan Police Hospital, Nakano-Ku, Japan|IUHW Narita Hospital, Narita, Japan|Houjin Syadan Kouhoukai Takagi Hospital, Okawa-Shi, Japan|Okayama City Hospital, Okayama, Japan|Ome Municipal General Hospital, Ome-Shi, Japan|Osaka City General Hospital, Osaka, Japan|National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai-shi, Japan|Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai, Shinagawa, Japan|St. Luke's International Hospital, Tokyo, Japan|Edogawa Medicare Hospital, Tokyo, Japan|Center Hospital of the National Center for Global Health and Medicine, Tokyo, Japan|JCHO Tokyo Shinjuku Medical Center, Tokyo, Japan|Tokyo Medical University Hachioji Medical Center, Tokyo, Japan|National Hospital Organization Kasumigaura Medical Center, Tsuchiurat, Japan|Mie Prefectural Medical Centre, Yokkaichi, Japan|CIMAB SA de CV, Torreón, Coahuila, Mexico|Panamerican Clinical Research S.A de C.V., Guadalajara, Jalisco, Mexico|Clinstile S.A de C.V., Mexico City, Mexico CITY (federal District), Mexico|PanAmerican Clinical Research, Querétaro, Queréaro, Queretaro, Mexico|Instituto Jalisciense de Investigacion Clinica S.A. de C.V., Guadalajara, Mexico|Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico, Mexico|CEPREP; Hospital Universitario, Monterrey, Mexico|Hospital Senhora da Oliveira - Guimaraes, E.P.E, Guimarães, Portugal|Centro Hospitalar de Leiria (CHL), Leiria, Portugal|Unidade Local de Saude de Matosinhos SA, Matosinhos, Portugal|Prof. Dr. Matei Bals Institute of Infectious Diseases, Bucuresti, Romania|County Hospital Caracal, Caracal, Romania|Sibiu Emergency Clinical County Hospital, Sibiu, Romania|Dr. Victor Babes Clinical Hospital of Pneumophthisiology and Infectious Diseases, Timişoara, Romania|Dr JM Engelbrecht Trial site, Cape Town, South Africa|TASK Eden, George, South Africa|Langeberg Clinical Trials, Kraaifontein, South Africa|Clinical Projects Research, Worcester, South Africa|Hôpital Universitaire de Genève (HUG), Genève, Switzerland|Universitätsspital Zürich, Zürich, Switzerland|Gazi Universitesi Tip Fakultesi, Ankara, Turkey|Hacettepe University Medical Faculty, Ankara, Turkey|Koc University Medical Faculty Hospital, Istanbul, Turkey|Ege University Medical Faculty, Izmir, Turkey|Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey|Ankara University Medical Faculty - PPDS, Çankaya, Turkey|Istanbul University Cerrahpasa Medical Faculty Hospital; Tesvikiye Caddesi No:20, Şi̇şli̇, Turkey|Municipal Non-profit enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council, Ivano-Frankivsk, Katerynoslav Governorate, Ukraine|Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council, Kharkiv, Kharkiv Governorate, Ukraine|Public Non-Profit Enterprise "City Outpatient Clinic #9" of Kharkiv City Council, Kharkiv, Kharkiv Governorate, Ukraine|CNPE City Clinical Hospital #6 of DCC, Dnipro, Kholm Governorate, Ukraine|Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council, Dnipro, KIEV Governorate, Ukraine|CNPE Ivano-Frankivsk Regional Centre of Phthisiology and Pulmonology of IFRC, Ivano Frankivsk, KIEV Governorate, Ukraine|Private Enterprise Private Manufacture Company "Acinus", diagnostic and treatment center, Kirovograd, KIEV Governorate, Ukraine|Medical Center LLC "Harmony of Beauty", Kyiv, KIEV Governorate, Ukraine|CNE Kyiv City Clinical Hospital#1 of Exec. Body, Kyiv, KIEV Governorate, Ukraine|Medical Center of LLC Preventclinic, Kyiv, KIEV Governorate, Ukraine|Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail, Kyiv, KIEV Governorate, Ukraine|Polyclinic of Center of Medical Service and Rehabilitation of State JSHC Artem, Kyiv, KIEV Governorate, Ukraine|Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1, Vinnytsya, Podolia Governorate, Ukraine|Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council, Zaporizhzhia, Tavria Okruha, Ukraine
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 1386
- Age - 12 Years and older (Child, Adult, Older Adult)
- Outcome measures - Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 hours)|Time to Alleviation or Improvement of COVID-19 Symptoms (43 hours)|Time to Alleviation of COVID-19 Symptoms (21.5 hours)|Time to Alleviation of COVID-19 Symptoms (43 hours)|Time to One-Category Improvement of Baseline Presenting COVID-19 Symptoms|Time to Alleviation of Individual Symptoms|Proportion of Participants Requiring Hospitalization for COVID-19|Proportion of Participants with Greater than or Equal to 1 COVID-19 Related Medically Attended Visit|Duration of Fever|Frequency of COVID-19 Related Complications|Proportion of Participants with any Post-Treatment Infection|Change from Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA|Time to Cessation of SARS-CoV-2 Viral Shedding|Proportion of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints|Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA|Percentage of Participants with Adverse Events (AEs)|Plasma Concentration of AT-511, AT-551, AT-229 and AT-273 at Specified Timepoints
|
NCT04396106
|
Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting |
Recruiting |
Phase 2 |
May/26/2020 |
Aug/01/2022 |
- Alternative id - AT-03A-001
- Interventions - Drug: AT-527|Other: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Atea Study Site, Scottsdale, Arizona, United States|Atea Study Site, Davis, California, United States|Atea Study Site, Los Angeles, California, United States|Atea Study Site, Washington, District of Columbia, United States|Atea Study Site, Orlando, Florida, United States|Atea Study Site, Atlanta, Georgia, United States|Atea Study Site, Chicago, Illinois, United States|Atea Study Site, Chicago, Illinois, United States|Atea Study Site, Boston, Massachusetts, United States|Atea Study Site, Butte, Montana, United States|Atea Study Site, Charlotte, North Carolina, United States|Atea Study Site, Cincinnati, Ohio, United States|Atea Study Site, Columbus, Ohio, United States|Atea Study Site, Charleston, South Carolina, United States|Atea Study Site, Columbia, South Carolina, United States|Atea Study Site, Rosario, Argentina|Atea Study Site, Vicente Lopez, Argentina|Atea Study Site, Brussels, Belgium|Atea Study Site, Mechelen, Belgium|Atea Study Site, Belo Horizonte, Brazil|Atea Study Site, Brasília, Brazil|Atea Study Site, Campo Largo, Brazil|Atea Study Site, Porto Alegre, Brazil|Atea Study Site, São Paulo, Brazil|Atea Study Site, Cairo, Egypt|Atea Study Site, Chisinau, Moldova, Republic of|Atea Study Site, Bucharest, Romania|Atea Study Site, Bloemfontein, South Africa|Atea Study Site, Cape Town, South Africa|Atea Study Site, Centurion, South Africa|Atea Study Site, George, South Africa|Atea Study Site, Worcester, South Africa|Atea Study Site, Barcelona, Spain|Atea Study Site, Madrid, Spain|Atea Study Site, Pozuelo De Alarcón, Spain|Atea Study Site, Brovary, Ukraine|Atea Study Site, Kyiv, Ukraine
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 190
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Part A: Proportions (active vs. placebo) of subjects with progressive respiratory insufficiency.|Part B: Change from baseline in amount of SARS-CoV-2 virus RNA|Parts A and B: Proportions (active vs. placebo) of subjects experiencing treatment-emergent adverse events|Part A: Change from baseline in amount of SARS-CoV-2 virus RNA
|