COVID-19 Clinical Trial
Official title:
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19
| Verified date | April 2024 |
| Source | Atea Pharmaceuticals, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the study is to evaluate whether bemnifosbuvir (BEM) is effective and safe in adults with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible subjects will be randomly assigned (by chance) to receive BEM or matching placebo orally for 5 days. Co-administration of locally available standard of care (SOC) is allowed. The total duration of the study is 60 days.
| Status | Active, not recruiting |
| Enrollment | 2295 |
| Est. completion date | May 31, 2024 |
| Est. primary completion date | April 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Positive SARS-CoV-2 test conducted = 5 days prior to randomization - Mild or moderate COVID-19 with symptom onset = 5 days before randomization and at least one COVID-19 related symptom present at time of screening - Subject must be high risk, defined below: 1. Age =70 years OR 2. Age =55 years with one of the following: i) obesity (body mass index [BMI] =30 kg/m2) ii) diabetes mellitus iii) cardiovascular disease or hypertension iv) chronic lung disease requiring routine therapy OR 3. Age 50 to 54 years with two of the following: i) obesity (BMI =30 kg/m2) ii) diabetes mellitus iii) cardiovascular disease or hypertension iv) chronic lung disease requiring routine therapy OR 4. Age =18 years with one of the following: i) Down syndrome, sickle cell disease, dementia, Parkinson's disease, or care home residents ii) One of the following immunocompromising conditions or immunosuppressive treatments: receiving chemotherapy for cancer, hematologic malignancy, being within 2 years of a hematopoietic stem cell transplant, receipt of a solid organ transplant and on immunosuppressive therapy, human immunodeficiency virus (HIV) infection untreated or with CD4+ T lymphocyte count <350 cells per cubic millimeter, moderate/severe primary immunodeficiency, taking immunosuppressive medications - Use of adequate contraception for females of childbearing potential Exclusion Criteria: - Severe or critical COVID-19 illness - Admitted to a hospital within 90 days prior to randomization due to COVID-19 - Use of other investigational drugs within 30 days prior to planned dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study - Initiation or planned initiation of remdesivir for treatment of the current SARS-CoV-2 infection - Requirement of prohibited medications, including hydroxychloroquine or amiodarone within 3 months prior to screening. Note: Subjects who had already initiated any COVID-19 drug with antiviral effects intended to treat symptomatic SARS-CoV-2 infection (= 24 hours prior to randomization) will be excluded. During screening (or within 24 hours prior to or after randomization), locally available COVID-19 drugs with antiviral effects (including but not limited to nirmatrelvir/ritonavir, molnupiravir, favipiravir, monoclonal antibodies) will be permitted. - Other known active viral or bacterial infection at the time of screening, such as influenza and respiratory syncytial virus (RSV). Note: This exclusion does not apply to subjects with stable chronic viral infections, such as chronic hepatitis C virus (HCV) or HIV providing other eligibility criteria are met. - Receiving dialysis or have known severe renal impairment - History of severe hepatic impairment (Child-Pugh Class C) - Known allergy or hypersensitivity to components of study drug |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Atea Study Site | Bahía Blanca | Buenos Aires |
| Argentina | Atea Study Site | Buenos Aires | Ciudad Autonoma Buenos Aires |
| Argentina | Atea Study Site | Ciudad Autonoma de Buenos Aire | Buenos Aires |
| Argentina | Atea Study Site | Ciudad Autonoma de Buenos Aire | |
| Argentina | Atea Study Site | Córdoba | |
| Argentina | Atea Study Site | Córdoba | Cordoba |
| Argentina | Atea Study Site | Mar Del Plata | Buenos Aires |
| Argentina | Atea Study Site | Mar Del Plata | Buenos Aires |
| Argentina | Atea Study Site | Ramos Mejía | Buenos Aires |
| Argentina | Atea Study Site | Rosario | Santa Fe |
| Argentina | Atea Study Site | Rosario | Santa Fe |
| Argentina | Atea Study Site | San Miguel De Tucumán | Tucuman |
| Argentina | Atea Study Site | San Miguel De Tucumán | Tucuman |
| Argentina | Atea Study Site | San Nicolas | Buenos Aires |
| Argentina | Atea Study Site | Santiago Del Estero | |
| Brazil | Atea Study Site | Barretos | Sao Paulo |
| Brazil | Atea Study Site | Belo Horizonte | Minas Gerais |
| Brazil | Atea Study Site | Belo Horizonte | Minas Gerais |
| Brazil | Atea Study Site | Belo Horizonte | Minas Gerais |
| Brazil | Atea Study Site | Bento Gonçalves | Sao Paulo |
| Brazil | Atea Study Site | Blumenau | Santa Catarina |
| Brazil | Atea Study Site | Botucatu | Sao Paulo |
| Brazil | Atea Study Site | Brasília | Distrito Federal |
| Brazil | Atea Study Site | Cachoeiro De Itapemirim | Espirito Santo |
| Brazil | Atea Study Site | Campina Grande Do Sul | Parana |
| Brazil | Atea Study Site | Campinas | Sao Paulo |
| Brazil | Atea Study Site | Cuiabá | Mato Grosso |
| Brazil | Atea Study Site | Florianópolis | Santa Catarina |
| Brazil | Atea Study Site | Fortaleza | Ceara |
| Brazil | Atea Study Site | Fortaleza | Ceara |
| Brazil | Atea Study Site | Ijuí | Sao Paulo |
| Brazil | Atea Study Site | Itajaí | Santa Catarina |
| Brazil | Atea Study Site | Itajaí | Santa Catarina |
| Brazil | Atea Study Site | Jaú | Sao Paulo |
| Brazil | Atea Study Site | Joinville | Santa Catarina |
| Brazil | Atea Study Site | Maceió | Alagoas |
| Brazil | Atea Study Site | Natal | Rio Grande Do Norte |
| Brazil | Atea Study Site | Natal | Rio Grande Do Norte |
| Brazil | Atea Study Site | Osasco | Sao Paulo |
| Brazil | Atea Study Site | Passo Fundo | Rio Grande Do Sul |
| Brazil | Atea Study Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | Atea Study Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | Atea Study Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | Atea Study Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | Atea Study Site | Porto Velho | Rondonia |
| Brazil | Atea Study Site | Ribeirão Preto | Sao Paulo |
| Brazil | Atea Study Site | Rio De Janeiro | |
| Brazil | Atea Study Site | Rio De Janeiro | Rio Do Janeiro |
| Brazil | Atea Study Site | Salvador | Bahia |
| Brazil | Atea Study Site | Salvador | Bahia |
| Brazil | Atea Study Site | Santa Catarina | Sao Paulo |
| Brazil | Atea Study Site | São José Do Rio Preto | Sao Paulo |
| Brazil | Atea Study Site | São Paulo | Sao Paulo |
| Brazil | Atea Study Site | São Paulo | Sao Paulo |
| Brazil | Atea Study Site | São Paulo | Sao Paulo |
| Brazil | Atea Study Site | São Paulo | Sao Paulo |
| Brazil | Atea Study Site | Serra | Espirito Santo |
| Brazil | Atea Study Site | Valinhos | São Paulo |
| Brazil | Atea Study Site | Vitória | Espirito Santo |
| Canada | Atea Study Site | Chicoutimi | Quebec |
| Canada | Atea Study Site | Edmonton | Alberta |
| Germany | Atea Study Site | Berlin | |
| Germany | Atea Study Site | Frankfurt am Main | Hessen |
| Germany | Atea Study Site | Hamburg | |
| Germany | Atea Study Site | Muenchen | Bayern |
| India | Atea Study Site | Ahmedabad | Gujarat |
| India | Atea Study Site | Bangalore | Karnataka |
| India | Atea Study Site | Bangalore | Karnataka |
| India | Atea Study Site | Bangalore | Karnataka |
| India | Atea Study Site | Bengaluru | Karnataka |
| India | Atea Study Site | Chennai | Tamilnadu |
| India | Atea Study Site | Dombivli | Maharashtra |
| India | Atea Study Site | Faridabad | Haryana |
| India | Atea Study Site | Gotri | Gujarat |
| India | Atea Study Site | Hyderabad | Andhra Pradesh |
| India | Atea Study Site | Jaipur | Rajasthan |
| India | Atea Study Site | Jaipur | Rajasthan |
| India | Atea Study Site | Nashik | Maharashtra |
| India | Atea Study Site | Nashik | Maharashtra |
| India | Atea Study Site | Nellore | Andhra Pradesh |
| India | Atea Study Site | Nellore | Andhra Prasesh |
| India | Atea Study Site | New Delhi | Delhi |
| India | Atea Study Site | Pune | Maharashtra |
| India | Atea Study Site | Surat | Gujarat |
| India | Atea Study Site | Surat | Gujarat |
| India | Atea Study Site | Visakhapatnam | Andhra Pradesh |
| Japan | Atea Study Site | Chiba | |
| Japan | Atea Study Site | Fujisawa | Kanagawa |
| Japan | Atea Study Site | Fukuoka | |
| Japan | Atea Study Site | Fukuoka | Fukuoka City |
| Japan | Atea Study Site | Fukuoka-Shi | Fukuoka-Ken |
| Japan | Atea Study Site | Himeji | Hyogo |
| Japan | Atea Study Site | Izumisano | Osaka |
| Japan | Atea Study Site | Kamakura | Kanagawa |
| Japan | Atea Study Site | Kanazawa | Ishikawa |
| Japan | Atea Study Site | Kasuga | Fukuoka |
| Japan | Atea Study Site | Kitakyushu | Fukuoka-Ken |
| Japan | Atea Study Site | Okayama | |
| Japan | Atea Study Site | Sapporo | Hokkaido |
| Japan | Atea Study Site | Toda | Saitama |
| Japan | Atea Study Site | Tsuchiura | Ibaraki |
| Japan | Atea Study Site | Uozu | Toyama |
| Latvia | Atea Study Site | Daugavpils | |
| Latvia | Atea Study Site | Riga | |
| Mexico | Atea Study Site | Cancún | Quintana Roo |
| Mexico | Atea Study Site | Chihuahua | |
| Mexico | Atea Study Site | Ciudad de mexico | Mexico City |
| Mexico | Atea Study Site | Guadalajara | Jalisco |
| Mexico | Atea Study Site | Mexico | Distrito Federal |
| Mexico | Atea Study Site | Monterrey | Nuevo Leon |
| Mexico | Atea Study Site | Monterrey | Nuevo Leon |
| Mexico | Atea Study Site | Monterrey | Nuevo Leon |
| Mexico | Atea Study Site | Monterrey | Nuevo Leon |
| Mexico | Atea Study Site | Monterrey | Nuevo Leon |
| Mexico | Atea Study Site | Oaxaca | |
| Mexico | Atea Study Site | Puebla | |
| Mexico | Atea Study Site | Querétaro | Queretaro |
| Mexico | Atea Study Site | Saltillo | Coahuila |
| Mexico | Atea Study site | San Luis Potosí | San Luis Potos |
| Mexico | Atea Study Site | Torreon | Coahuila |
| Mexico | Atea Study Site | Veracruz | |
| Mexico | Atea Study Site | Veracruz | |
| Mexico | Atea Study Site | Yucatán | Yucatan |
| Netherlands | Atea Study Site | Den Haag | |
| Netherlands | Atea Study Site | Den Haag | |
| Netherlands | Atea Study Site | Utrecht | |
| Netherlands | Atea Study Site | Zwijndrecht | |
| Netherlands | Atea Study Site | Zwijndrecht | |
| Pakistan | Atea Study Site | Islamabad | |
| Pakistan | Atea Study Site | Karachi | |
| Pakistan | Atea Study Site | Karachi | |
| Pakistan | Atea Study Site | Lahore | |
| Pakistan | Atea Study Site | Rawalpindi | |
| Philippines | Atea Study Site | Baguio City | Cordillera |
| Philippines | Atea Study Site | Ermita | Manila |
| Philippines | Atea Study Site | Iloilo City | |
| Philippines | Atea Study Site | Mandaluyong | |
| Philippines | Atea Study Site | San Fernando | Pampanga |
| Philippines | Atea Study Site | Tacloban City | Leyte |
| Romania | Atea Study Site | Balotesti | |
| Romania | Atea Study Site | Bucharest | |
| Romania | Atea Study Site | Bucuresti | |
| Romania | Atea Study Site | Bucuresti | |
| Romania | Atea Study Site | Bucuresti | |
| Romania | Atea Study Site | Constanta | |
| Romania | Atea Study Site | Craiova | |
| Romania | Atea Study Site | Oradea | |
| Romania | Atea Study Site | Sibiu | |
| Romania | Atea Study Site | Suceava | |
| Romania | Atea Study Site | Timisoara | |
| South Africa | Atea Study Site | Cape Town | Western Cape |
| South Africa | Atea Study Site | East London | Eastern Cape |
| South Africa | Atea Study Site | Johannesburg | Gauteng |
| South Africa | Atea Study Site | Kimberley | Northern Cape |
| South Africa | Atea Study Site | Plettenberg Bay | Western Cape |
| South Africa | Atea Study Site | Pretoria | Gauteng |
| South Africa | Atea Study Site | Pretoria | Gauteng |
| South Africa | Atea Study Site | Pretoria | Gauteng |
| South Africa | Atea Study Site | Randburg | Gauteng |
| South Africa | Atea Study Site | Thabazimbi | Limpopo |
| Spain | Atea Study Site | Badalona | Barcelona |
| Spain | Atea Study Site | Barcelona | |
| Spain | Atea Study Site | Centelles | Barcelona |
| Spain | Atea Study Site | Madrid | |
| Spain | Atea Study Site | Málaga | Malaga |
| Spain | Atea Study Site | Marbella | Malaga |
| Sweden | Atea Study Site | Solna | |
| Sweden | Atea Study Site | Umeå | |
| Tunisia | Atea Study Site | La Marsa | |
| Tunisia | Atea Study Site | Monastir | |
| Tunisia | Atea Study Site | Montfleury | |
| Tunisia | Atea Study Site | Sfax | |
| Tunisia | Atea Study Site | Sousse | |
| Tunisia | Atea Study Site | Sousse | |
| Tunisia | Atea Study Site | Tunis | |
| Tunisia | Atea Study Site | Tunis | |
| Turkey | Atea Study Site | Ankara | |
| Turkey | Atea Study Site | Ankara | |
| Turkey | Atea Study Site | Ankara | |
| Turkey | Atea Study Site | Ankara | |
| Turkey | Atea Study Site | Ankara | |
| Turkey | Atea Study Site | Antalya | |
| Turkey | Atea Study Site | Antalya | |
| Turkey | Atea Study Site | Bursa | |
| Turkey | Atea Study SIte | Denizli | |
| Turkey | Atea Study Site | Istanbul | |
| Turkey | Atea Study Site | Istanbul | |
| Turkey | Atea Study Site | Istanbul | |
| Turkey | Atea Study Site | Istanbul | |
| Turkey | Atea Study Site | Istanbul | |
| Turkey | Atea Study Site | Istanbul | |
| Turkey | Atea Study Site | Izmir | |
| Turkey | Atea Study Site | Izmir | |
| Turkey | Atea Study Site | Izmir | |
| Turkey | Atea Study Site | Izmir | |
| Turkey | Atea Study SIte | Kayseri | |
| Turkey | Atea Study Site | Samsun | |
| Turkey | Atea Study Site | Yenimahalle | |
| United Kingdom | Atea Study Site | Castleford | West Yourkshire |
| United Kingdom | Atea Study Site | Exeter | Devon |
| United Kingdom | Atea Study Site | London | Greater London |
| United Kingdom | Atea Study Site | London | Greater London |
| United Kingdom | Atea Study Site | Plymouth | Devon |
| United States | Atea Study Site | Bronx | New York |
| United States | Atea Study Site | Bronx | New York |
| United States | Atea Study Site | Canoga Park | California |
| United States | Atea Study Site | Carrollton | Texas |
| United States | Atea Study Site | Chapel Hill | North Carolina |
| United States | Atea Study Site | Chickasha | Oklahoma |
| United States | Atea Study Site | Coral Gables | Florida |
| United States | Atea Study Site | Cutler Bay | Florida |
| United States | Atea Study Site | Dallas | Texas |
| United States | Atea Study Site | DeSoto | Texas |
| United States | Atea Study Site | Doral | Florida |
| United States | Atea Study Site | Eatonton | Georgia |
| United States | Atea Study Site | Forney | Texas |
| United States | Atea Study Site | Fort Worth | Texas |
| United States | Atea Study Site | Fullerton | California |
| United States | Atea Study Site | Greenville | South Carolina |
| United States | Atea Study Site | Harlingen | Texas |
| United States | Atea Study Site | Hialeah | Florida |
| United States | Atea Study Site | High Point | North Carolina |
| United States | Atea Study Site | Houston | Texas |
| United States | Atea Study Site | Inglewood | California |
| United States | Atea Study Site | Kingman | Arizona |
| United States | Atea Study Site | Kingwood | Texas |
| United States | Atea Study Site | La Palma | California |
| United States | Atea Study Site | La Vista | Nebraska |
| United States | Atea Study Site | Lewisville | Texas |
| United States | Atea Study Site | Long Beach | California |
| United States | Atea Study Site | Long Beach | California |
| United States | Atea Study Site | Los Angeles | California |
| United States | Atea Study Site | Mesquite | Texas |
| United States | Atea Study Site | Miami | Florida |
| United States | Atea Study Site | Miami | Florida |
| United States | Atea Study Site | Miami | Florida |
| United States | Atea Study Site | Miami | Florida |
| United States | Atea Study Site | Miami | Florida |
| United States | Atea Study Site | Miami | Florida |
| United States | Atea Study Site | Miami | Florida |
| United States | Atea Study Site | Miami Gardens | Florida |
| United States | Atea Study Site | North Miami Beach | Florida |
| United States | Atea Study Site | North Miami Beach | Florida |
| United States | Atea Study Site | Orland Park | Illinois |
| United States | Atea Study Site | Pembroke Pines | Florida |
| United States | Atea Study Site | Pompano Beach | Florida |
| United States | Atea Study Site | Prescott | Arizona |
| United States | Atea Study Site | Providence | Rhode Island |
| United States | Atea Study Site | Rock Hill | South Carolina |
| United States | Atea Study Site | Sacramento | California |
| United States | Atea Study Site | San Antonio | Texas |
| United States | Atea Study Site | San Diego | California |
| United States | Atea Study Site | Splendora | Texas |
| United States | Atea Study Site | Stafford | Texas |
| United States | Atea Study Site | Sugar Land | Texas |
| United States | Atea Study Site | Surprise | Arizona |
| United States | Atea Study Site | Tampa | Florida |
| United States | Atea Study Site | Tampa | Florida |
| United States | Atea Study Site | Tampa | Florida |
| United States | Atea Study Site | Tampa | Florida |
| United States | Atea Study Site | The Villages | Florida |
| United States | Atea Study Site | Tucson | Arizona |
| United States | Atea Study Site | W. Miami | Florida |
| United States | Atea Study Site | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Atea Pharmaceuticals, Inc. |
United States, Argentina, Brazil, Canada, Germany, India, Japan, Latvia, Mexico, Netherlands, Pakistan, Philippines, Romania, South Africa, Spain, Sweden, Tunisia, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of subjects hospitalized for any cause or died due to any cause | Day 1 through Day 29 | ||
| Secondary | Proportion of subjects hospitalized due to COVID-19 or died due to any cause | Day 1 through Day 29 | ||
| Secondary | Proportion of subjects who died due to any cause | Day 1 through Day 29; Day 1 through Day 60 | ||
| Secondary | Proportion of subjects with COVID-19-related complications | Day 1 through Day 29 | ||
| Secondary | Proportion of subjects with COVID-19-medically attended visits (hospitalization, emergency room (ER) visit, urgent care visit, physician's office visit, or telemedicine visit) or who died due to any cause | Day 1 through Day 29; Day 1 through Day 60 | ||
| Secondary | Proportion of subjects with COVID-19 symptom relapse | Day 1 through Day 29 | ||
| Secondary | Proportion of subjects with viral load rebound | Day 1 through Day 29 |
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