SUNRISE-3: Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19

NCT05629962 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: AT-03A-017
• Study Type: interventional
• Target: 2,285
• Locations: 18 countries
• Sites: 255

Brief Summary

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.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2 Infection); COVID-19

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Hospitalized for Any Cause or Died Due to Any Cause

  Day 1 through Day 29

Secondary Outcomes (6)

• Percentage of Subjects Hospitalized Due to COVID-19 or Died Due to Any Cause

  Day 1 through Day 29

• Percentage of Subjects Who Died Due to Any Cause

  Day 1 through Day 29; Day 1 through Day 60

• Percentage of Subjects With COVID-19-related Complications

  Day 1 through Day 29

• Percentage 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

• Percentage of Subjects With COVID-19 Symptom Relapse

  Day 1 through Day 29

Study Arms (2)

Bemnifosbuvir (BEM)

EXPERIMENTAL

Drug: Bemnifosbuvir (BEM)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Bemnifosbuvir (BEM) DRUG

BEM tablets administered orally every 12 hours (twice a day) for a total of 5 days

Also known as: AT-527

Bemnifosbuvir (BEM)

Placebo DRUG

Placebo tablets administered orally every 12 hours (twice a day) for a total of 5 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Age ≥70 years OR
• 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
• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Atea Pharmaceuticals, Inc.: lead

Study Sites (263)

Atea Study Site

Kingman, Arizona, 86401, United States

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Prescott, Arizona, 86301, United States

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Surprise, Arizona, 85378, United States

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Tucson, Arizona, 85741, United States

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Canoga Park, California, 91303, United States

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Fullerton, California, 92835, United States

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Inglewood, California, 90301, United States

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La Palma, California, 90623, United States

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Long Beach, California, 90805, United States

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Long Beach, California, 98015, United States

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Los Angeles, California, 90017, United States

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Sacramento, California, 95817, United States

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San Diego, California, 92120, United States

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Coral Gables, Florida, 33134, United States

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Cutler Bay, Florida, 33189, United States

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Doral, Florida, 33172, United States

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Hialeah, Florida, 33010, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33135, United States

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Miami, Florida, 33155, United States

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Miami, Florida, 33165, United States

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Miami, Florida, 33173, United States

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Miami, Florida, 33184, United States

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Miami, Florida, 33186, United States

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Miami Gardens, Florida, 33014, United States

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North Miami Beach, Florida, 33162, United States

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North Miami Beach, Florida, 33179, United States

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Pembroke Pines, Florida, 33024, United States

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Pompano Beach, Florida, 33164, United States

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Tampa, Florida, 33607, United States

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Tampa, Florida, 33612, United States

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Tampa, Florida, 33614, United States

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Tampa, Florida, 33615, United States

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The Villages, Florida, 32162, United States

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West Miami, Florida, 33144, United States

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West Palm Beach, Florida, 33409, United States

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Eatonton, Georgia, 31024, United States

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Orland Park, Illinois, 60462, United States

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La Vista, Nebraska, 68128, United States

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The Bronx, New York, 10456, United States

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The Bronx, New York, 10467, United States

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Chapel Hill, North Carolina, 27514, United States

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High Point, North Carolina, 27260, United States

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Chickasha, Oklahoma, 73018, United States

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Providence, Rhode Island, 02903, United States

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Greenville, South Carolina, 29615, United States

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Rock Hill, South Carolina, 29732, United States

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Carrollton, Texas, 75006, United States

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Dallas, Texas, 75230, United States

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DeSoto, Texas, 75115, United States

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Forney, Texas, 75126, United States

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Fort Worth, Texas, 76164, United States

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Harlingen, Texas, 78550, United States

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Houston, Texas, 77065, United States

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Kingwood, Texas, 77339, United States

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Lewisville, Texas, 75057, United States

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Mesquite, Texas, 75150, United States

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San Antonio, Texas, 78215, United States

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Splendora, Texas, 77372, United States

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Stafford, Texas, 77477, United States

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Sugar Land, Texas, 77479, United States

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Bahía Blanca, Buenos Aires, B800FTD, Argentina

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Ciudad Autonoma de Buenos Aire, Buenos Aires, C1056ABJ, Argentina

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Mar del Plata, Buenos Aires, B7600FYK, Argentina

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Mar del Plata, Buenos Aires, B7602DCK, Argentina

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Ramos Mejía, Buenos Aires, 1704, Argentina

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San Nicolás de los Arroyos, Buenos Aires, B2900DMH, Argentina

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Buenos Aires, Ciudad Autonoma Buenos Aires, C1180AAX, Argentina

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Córdoba, Córdoba Province, 5000, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Rosario, Santa Fe Province, S2000PBJ, Argentina

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

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Ciudad Autonoma de Buenos Aire, C1202ABB, Argentina

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Córdoba, CPX5000EPU, Argentina

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Santiago del Estero, 4200, Argentina

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Maceió, Alagoas, 57052-580, Brazil

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Fortaleza, Ceará, 60160-070, Brazil

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Fortaleza, Ceará, 60430-370, Brazil

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Cachoeiro de Itapemirim, Espírito Santo, 2938-020, Brazil

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Serra, Espírito Santo, 29101-850, Brazil

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Vitória, Espírito Santo, 29043-260, Brazil

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Salvador, Estado de Bahia, 40050-410, Brazil

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Salvador, Estado de Bahia, 40150, Brazil

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Brasília, Federal District, 70710-100, Brazil

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Cuiabá, Mato Grosso, 78048, Brazil

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Belo Horizonte, Minas Gerais, 30110-934, Brazil

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Belo Horizonte, Minas Gerais, 30150-221, Brazil

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Belo Horizonte, Minas Gerais, 30220-330, Brazil

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Campina Grande do Sul, Paraná, 83430-000, Brazil

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Rio de Janeiro, Rio Do Janeiro, 20241-180, Brazil

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Natal, Rio Grande do Norte, 59020-500, Brazil

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Natal, Rio Grande do Norte, 59025, Brazil

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Passo Fundo, Rio Grande do Sul, 99010-260, Brazil

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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-004, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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Porto Velho, Rondônia, 78918-791, Brazil

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Blumenau, Santa Catarina, 89020-430, Brazil

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Florianópolis, Santa Catarina, 88015, Brazil

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Itajaí, Santa Catarina, 88301-220, Brazil

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Itajaí, Santa Catarina, 88301-260, Brazil

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Joinville, Santa Catarina, 89201, Brazil

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Barretos, São Paulo, 14784-400, Brazil

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Bento Gonçalves, São Paulo, 95700-084, Brazil

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Botucatu, São Paulo, 18618-970, Brazil

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Campinas, São Paulo, 13075, Brazil

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Ijuí, São Paulo, 98700-000, Brazil

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Jaú, São Paulo, 17210-120, Brazil

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Osasco, São Paulo, 06013-070, Brazil

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Ribeirão Preto, São Paulo, 14048-900, Brazil

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Santa Catarina, São Paulo, 88811-000, Brazil

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São José do Rio Preto, São Paulo, 15090-000, Brazil

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São Paulo, São Paulo, 01509, Brazil

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São Paulo, São Paulo, 04038-002, Brazil

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São Paulo, São Paulo, 05403-000, Brazil

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São Paulo, São Paulo, 08270-120, Brazil

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Valinhos, São Paulo, 13271-130, Brazil

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Rio de Janeiro, 20241-180, Brazil

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Edmonton, Alberta, T5A 4L8, Canada

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Chicoutimi, Quebec, G7H 7Y8, Canada

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Munich, Bavaria, 80336, Germany

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Frankfurt am Main, Hesse, 60596, Germany

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Berlin, 13353, Germany

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Hamburg, 22143, Germany

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Hyderabad, Andhra Pradesh, 500018, India

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Nellore, Andhra Pradesh, 524001, India

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Visakhapatnam, Andhra Pradesh, 530002, India

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Nellore, Andhra Prasesh, 524001, India

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Ahmedabad, Gujarat, 380006, India

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Gotri, Gujarat, 390021, India

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Surat, Gujarat, 395004, India

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Surat, Gujarat, 395010, India

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Faridabad, Haryana, 121001, India

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Bangalore, Karnataka, 560049, India

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Bangalore, Karnataka, 560060, India

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Bangalore, Karnataka, 560076, India

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Bengaluru, Karnataka, 560068, India

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Dombivali, Maharashtra, 421203, India

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Nashik, Maharashtra, 422005, India

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Nashik, Maharashtra, 422007, India

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Pune, Maharashtra, 411023, India

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New Delhi, National Capital Territory of Delhi, 110075, India

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Jaipur, Rajasthan, 302020, India

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Jaipur, Rajasthan, 30217, India

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Chennai, Tamil Nadu, 600113, India

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Fukuoka, Fukuoka, 810-0033, Japan

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Kasuga, Fukuoka, 816-0842, Japan

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Kitakyushu, Fukuoka, 807-0072, Japan

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Fukuoka, Fukuoka City, 819-0015, Japan

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Sapporo, Hokkaido, 065-0033, Japan

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Himeji, Hyōgo, 670-0849, Japan

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Tsuchiura, Ibaraki, 300-0062, Japan

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Kanazawa, Ishikawa-ken, 920-8650, Japan

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Fujisawa, Kanagawa, 251-0041, Japan

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Kamakura, Kanagawa, 247-8533, Japan

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Izumisano, Osaka, 598-8577, Japan

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Toda, Saitama, 335-0035, Japan

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Uozu, Toyama, 937-0042, Japan

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Chiba, 260-0852, Japan

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Fukuoka, 814-0153, Japan

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Okayama, 700-8557, Japan

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Daugavpils, LV-5410, Latvia

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Riga, LV-1010, Latvia

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Saltillo, Coahuila, 25020, Mexico

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Torreón, Coahuila, 27010, Mexico

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Guadalajara, Jalisco, 44180, Mexico

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Mexico City, Mexico City, 06700, Mexico

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Monterrey, Nuevo León, 64060, Mexico

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Monterrey, Nuevo León, 64310, Mexico

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Monterrey, Nuevo León, 64320, Mexico

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Monterrey, Nuevo León, 64460, Mexico

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Monterrey, Nuevo León, 64710, Mexico

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Querétaro City, Querétaro, 76100, Mexico

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Cancún, Quintana Roo, 77500, Mexico

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San Luis Potosí City, San Luis Potos, 78250, Mexico

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Yucatán, Yucatán, 97070, Mexico

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Chihuahua City, 31203, Mexico

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Oaxaca City, 68000, Mexico

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Puebla City, 72180, Mexico

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Veracruz, 91851, Mexico

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Veracruz, 91900, Mexico

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The Hague, 2565 KV, Netherlands

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The Hague, 2572, Netherlands

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Utrecht, 3584, Netherlands

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Zwijndrecht, 3333 GZ, Netherlands

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Zwijndrecht, 3334 SB, Netherlands

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Islamabad, 44000, Pakistan

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Karachi, 74800, Pakistan

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Karachi, 75600, Pakistan

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Lahore, 53100, Pakistan

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Rawalpindi, 44000, Pakistan

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Baguio City, Cordillera, 2600, Philippines

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Tacloban City, Leyte, 6500, Philippines

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Ermita, Manila, Philippines

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San Fernando City, Pampanga, Philippines

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Iloilo City, 5000, Philippines

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Mandaluyong, 1552, Philippines

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Baloteşti, 077015, Romania

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Bucharest, 022328, Romania

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Bucharest, 030303, Romania

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Bucharest, 050159, Romania

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Bucharest, 21105, Romania

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Constanța, 900591, Romania

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Craiova, 200515, Romania

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Oradea, 410167, Romania

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Sibiu, 550245, Romania

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Suceava, 720201, Romania

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Timișoara, Romania

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East London, Eastern Cape, 5219, South Africa

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Johannesburg, Gauteng, 1724, South Africa

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Pretoria, Gauteng, 0184, South Africa

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Pretoria, Gauteng, 181, South Africa

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Pretoria, Gauteng, 183, South Africa

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Randburg, Gauteng, 2087, South Africa

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Thabazimbi, Limpopo, 380, South Africa

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Kimberley, Northern Cape, 8301, South Africa

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Cape Town, Western Cape, 7570, South Africa

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Plettenberg Bay, Western Cape, 6600, South Africa

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Badalona, Barcelona, 8916, Spain

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Centelles, Barcelona, 8540, Spain

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Marbella, Malaga, 29603, Spain

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Málaga, Malaga, 29014, Spain

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Barcelona, 08028, Spain

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Madrid, 28046, Spain

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Solna, 17164, Sweden

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Umeå, 90185, Sweden

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La Marsa, 2070, Tunisia

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Monastir, 5000, Tunisia

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Montfleury, 1008, Tunisia

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Sfax, 3000, Tunisia

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Sousse, 4000, Tunisia

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Sousse, 4011, Tunisia

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Tunis, 1006, Tunisia

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Tunis, 1029, Tunisia

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Ankara, 06230, Turkey (Türkiye)

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Ankara, 6010, Turkey (Türkiye)

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Ankara, 6230, Turkey (Türkiye)

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Ankara, 6290, Turkey (Türkiye)

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Ankara, 6800, Turkey (Türkiye)

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Antalya, 7070, Turkey (Türkiye)

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Antalya, 7460, Turkey (Türkiye)

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Bursa, 16310, Turkey (Türkiye)

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Atea Study SIte

Denizli, 20160, Turkey (Türkiye)

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Atea Study Site

Istanbul, 34093, Turkey (Türkiye)

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Atea Study Site

Istanbul, 34098, Turkey (Türkiye)

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Istanbul, 34722, Turkey (Türkiye)

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Atea Study Site

Istanbul, 34785, Turkey (Türkiye)

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Istanbul, 34844, Turkey (Türkiye)

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Istanbul, 34899, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Izmir, 35120, Turkey (Türkiye)

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Izmir, 35360, Turkey (Türkiye)

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Izmir, 35620, Turkey (Türkiye)

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Atea Study SIte

Kayseri, 38080, Turkey (Türkiye)

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Atea Study Site

Samsun, 55270, Turkey (Türkiye)

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Yenimahalle, 06170, Turkey (Türkiye)

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Atea Study Site

Exeter, Devon, EX2 5DW, United Kingdom

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Plymouth, Devon, PL6 8DH, United Kingdom

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London, Greater London, N12 8BU, United Kingdom

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London, Greater London, SE1 7EH, United Kingdom

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Atea Study Site

Castleford, West Yourkshire, WF10 2QP, United Kingdom

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MeSH Terms

Conditions

COVID-19

Interventions

AT-511

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The study was originally designed based on available epidemiological data at the time including an assumed hospitalization or death rate in the range of 3% to 6%. The overall global decline in hospitalizations during the study ultimately blunted the ability to detect the efficacy of BEM.

Results Point of Contact

• Title: Atea Clinical Trials
• Organization: Atea Pharmaceuticals, Inc.

ateaclinicaltrials@ateapharma.com

1-857-284-8891

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: November 29, 2022
• Study Start: November 25, 2022
• Primary Completion: April 25, 2024
• Study Completion: May 30, 2024
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-05

Locations

PH (6); LA (2); RO (11); SE (2); TU (22); NL (5); PA (5); ES (6); CA (2); GB (5); ME (18); IN (21); AR (15); BR (44); ZA (10); JP (16); DE (4); US (61)