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

May 29, 2025 updated by: Atea Pharmaceuticals, Inc.

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2285

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Ciudad Autonoma de Buenos Aire, Argentina, C1202ABB
    - Atea Study Site
  - Córdoba, Argentina, CPX5000EPU
    - Atea Study Site
  - Santiago Del Estero, Argentina, 4200
    - Atea Study Site
- Buenos Aires
  - Bahía Blanca, Buenos Aires, Argentina, B800FTD
    - Atea Study Site
  - Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1056ABJ
    - Atea Study Site
  - Mar Del Plata, Buenos Aires, Argentina, B7600FYK
    - Atea Study Site
  - Mar Del Plata, Buenos Aires, Argentina, B7602DCK
    - Atea Study Site
  - Ramos Mejía, Buenos Aires, Argentina, 1704
    - Atea Study Site
  - San Nicolas, Buenos Aires, Argentina, B2900DMH
    - Atea Study Site
- Ciudad Autonoma Buenos Aires
  - Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, C1180AAX
    - Atea Study Site
- Cordoba
  - Córdoba, Cordoba, Argentina, 5000
    - Atea Study Site
- Santa Fe
  - Rosario, Santa Fe, Argentina, 2000
    - Atea Study Site
  - Rosario, Santa Fe, Argentina, S2000PBJ
    - Atea Study Site
- Tucuman
  - San Miguel De Tucumán, Tucuman, Argentina, 4000
    - Atea Study Site
  - San Miguel De Tucumán, Tucuman, Argentina, T4000AXL
    - Atea Study Site
Brazil
- - Rio De Janeiro, Brazil, 20241-180
    - Atea Study Site
- Alagoas
  - Maceió, Alagoas, Brazil, 57052-580
    - Atea Study Site
- Bahia
  - Salvador, Bahia, Brazil, 40050-410
    - Atea Study Site
  - Salvador, Bahia, Brazil, 40150
    - Atea Study Site
- Ceara
  - Fortaleza, Ceara, Brazil, 60160-070
    - Atea Study Site
  - Fortaleza, Ceara, Brazil, 60430-370
    - Atea Study Site
- Distrito Federal
  - Brasília, Distrito Federal, Brazil, 70710-100
    - Atea Study Site
- Espirito Santo
  - Cachoeiro De Itapemirim, Espirito Santo, Brazil, 2938-020
    - Atea Study Site
  - Serra, Espirito Santo, Brazil, 29101-850
    - Atea Study Site
  - Vitória, Espirito Santo, Brazil, 29043-260
    - Atea Study Site
- Mato Grosso
  - Cuiabá, Mato Grosso, Brazil, 78048
    - Atea Study Site
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30110-934
    - Atea Study Site
  - Belo Horizonte, Minas Gerais, Brazil, 30150-221
    - Atea Study Site
  - Belo Horizonte, Minas Gerais, Brazil, 30220-330
    - Atea Study Site
- Parana
  - Campina Grande Do Sul, Parana, Brazil, 83430-000
    - Atea Study Site
- Rio Do Janeiro
  - Rio De Janeiro, Rio Do Janeiro, Brazil, 20241-180
    - Atea Study Site
- Rio Grande Do Norte
  - Natal, Rio Grande Do Norte, Brazil, 59020-500
    - Atea Study Site
  - Natal, Rio Grande Do Norte, Brazil, 59025
    - Atea Study Site
- Rio Grande Do Sul
  - Passo Fundo, Rio Grande Do Sul, Brazil, 99010-260
    - Atea Study Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
    - Atea Study Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90035-004
    - Atea Study Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
    - Atea Study Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
    - Atea Study Site
- Rondonia
  - Porto Velho, Rondonia, Brazil, 78918-791
    - Atea Study Site
- Santa Catarina
  - Blumenau, Santa Catarina, Brazil, 89020-430
    - Atea Study Site
  - Florianópolis, Santa Catarina, Brazil, 88015
    - Atea Study Site
  - Itajaí, Santa Catarina, Brazil, 88301-220
    - Atea Study Site
  - Itajaí, Santa Catarina, Brazil, 88301-260
    - Atea Study Site
  - Joinville, Santa Catarina, Brazil, 89201
    - Atea Study Site
- Sao Paulo
  - Barretos, Sao Paulo, Brazil, 14784-400
    - Atea Study Site
  - Bento Gonçalves, Sao Paulo, Brazil, 95700-084
    - Atea Study Site
  - Botucatu, Sao Paulo, Brazil, 18618-970
    - Atea Study Site
  - Campinas, Sao Paulo, Brazil, 13075
    - Atea Study Site
  - Ijuí, Sao Paulo, Brazil, 98700-000
    - Atea Study Site
  - Jaú, Sao Paulo, Brazil, 17210-120
    - Atea Study Site
  - Osasco, Sao Paulo, Brazil, 06013-070
    - Atea Study Site
  - Ribeirão Preto, Sao Paulo, Brazil, 14048-900
    - Atea Study Site
  - Santa Catarina, Sao Paulo, Brazil, 88811-000
    - Atea Study Site
  - São José Do Rio Preto, Sao Paulo, Brazil, 15090-000
    - Atea Study Site
  - São Paulo, Sao Paulo, Brazil, 01509
    - Atea Study Site
  - São Paulo, Sao Paulo, Brazil, 04038-002
    - Atea Study Site
  - São Paulo, Sao Paulo, Brazil, 05403-000
    - Atea Study Site
  - São Paulo, Sao Paulo, Brazil, 08270-120
    - Atea Study Site
- São Paulo
  - Valinhos, São Paulo, Brazil, 13271-130
    - Atea Study Site
Canada
- Alberta
  - Edmonton, Alberta, Canada, T5A 4L8
    - Atea Study Site
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 7Y8
    - Atea Study Site
Germany
- - Berlin, Germany, 13353
    - Atea Study Site
  - Hamburg, Germany, 22143
    - Atea Study Site
- Bayern
  - Muenchen, Bayern, Germany, 80336
    - Atea Study Site
- Hessen
  - Frankfurt am Main, Hessen, Germany, 60596
    - Atea Study Site
India
- Andhra Pradesh
  - Hyderabad, Andhra Pradesh, India, 500018
    - Atea Study Site
  - Nellore, Andhra Pradesh, India, 524001
    - Atea Study Site
  - Visakhapatnam, Andhra Pradesh, India, 530002
    - Atea Study Site
- Andhra Prasesh
  - Nellore, Andhra Prasesh, India, 524001
    - Atea Study Site
- Delhi
  - New Delhi, Delhi, India, 110075
    - Atea Study Site
- Gujarat
  - Ahmedabad, Gujarat, India, 380006
    - Atea Study Site
  - Gotri, Gujarat, India, 390021
    - Atea Study Site
  - Sūrat, Gujarat, India, 395004
    - Atea Study Site
  - Sūrat, Gujarat, India, 395010
    - Atea Study Site
- Haryana
  - Faridabad, Haryana, India, 121001
    - Atea Study Site
- Karnataka
  - Bangalore, Karnataka, India, 560049
    - Atea Study Site
  - Bangalore, Karnataka, India, 560060
    - Atea Study Site
  - Bangalore, Karnataka, India, 560076
    - Atea Study Site
  - Bengaluru, Karnataka, India, 560068
    - Atea Study Site
- Maharashtra
  - Dombivli, Maharashtra, India, 421203
    - Atea Study Site
  - Nashik, Maharashtra, India, 422005
    - Atea Study Site
  - Nashik, Maharashtra, India, 422007
    - Atea Study Site
  - Pune, Maharashtra, India, 411023
    - Atea Study Site
- Rajasthan
  - Jaipur, Rajasthan, India, 302020
    - Atea Study Site
  - Jaipur, Rajasthan, India, 30217
    - Atea Study Site
- Tamilnadu
  - Chennai, Tamilnadu, India, 600113
    - Atea Study Site
Japan
- - Chiba, Japan, 260-0852
    - Atea Study Site
  - Fukuoka, Japan, 814-0153
    - Atea Study Site
  - Okayama, Japan, 700-8557
    - Atea Study Site
- Fukuoka
  - Kasuga, Fukuoka, Japan, 816-0842
    - Atea Study Site
- Fukuoka City
  - Fukuoka, Fukuoka City, Japan, 819-0015
    - Atea Study Site
- Fukuoka-Ken
  - Fukuoka-Shi, Fukuoka-Ken, Japan, 810-0033
    - Atea Study Site
  - Kitakyushu, Fukuoka-Ken, Japan, 807-0072
    - Atea Study Site
- Hokkaido
  - Sapporo, Hokkaido, Japan, 065-0033
    - Atea Study Site
- Hyogo
  - Himeji, Hyogo, Japan, 670-0849
    - Atea Study Site
- Ibaraki
  - Tsuchiura, Ibaraki, Japan, 300-0062
    - Atea Study Site
- Ishikawa
  - Kanazawa, Ishikawa, Japan, 920-8650
    - Atea Study Site
- Kanagawa
  - Fujisawa, Kanagawa, Japan, 251-0041
    - Atea Study Site
  - Kamakura, Kanagawa, Japan, 247-8533
    - Atea Study Site
- Osaka
  - Izumisano, Osaka, Japan, 598-8577
    - Atea Study Site
- Saitama
  - Toda, Saitama, Japan, 335-0035
    - Atea Study Site
- Toyama
  - Uozu, Toyama, Japan, 937-0042
    - Atea Study Site
Latvia
- - Daugavpils, Latvia, LV-5410
    - Atea Study Site
  - Riga, Latvia, LV-1010
    - Atea Study Site
Mexico
- - Chihuahua, Mexico, 31203
    - Atea Study Site
  - Oaxaca, Mexico, 68000
    - Atea Study Site
  - Puebla, Mexico, 72180
    - Atea Study Site
  - Veracruz, Mexico, 91851
    - Atea Study Site
  - Veracruz, Mexico, 91900
    - Atea Study Site
- Coahuila
  - Saltillo, Coahuila, Mexico, 25020
    - Atea Study Site
  - Torreon, Coahuila, Mexico, 27010
    - Atea Study Site
- Distrito Federal
  - Mexico, Distrito Federal, Mexico, 06700
    - Atea Study Site
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44180
    - Atea Study Site
- Mexico City
  - Ciudad de mexico, Mexico City, Mexico, 06700
    - Atea Study Site
- Nuevo Leon
  - Monterrey, Nuevo Leon, Mexico, 64060
    - Atea Study Site
  - Monterrey, Nuevo Leon, Mexico, 64310
    - Atea Study Site
  - Monterrey, Nuevo Leon, Mexico, 64320
    - Atea Study Site
  - Monterrey, Nuevo Leon, Mexico, 64460
    - Atea Study Site
  - Monterrey, Nuevo Leon, Mexico, 64710
    - Atea Study Site
- Queretaro
  - Querétaro, Queretaro, Mexico, 76100
    - Atea Study Site
- Quintana Roo
  - Cancún, Quintana Roo, Mexico, 77500
    - Atea Study Site
- San Luis Potos
  - San Luis Potosí, San Luis Potos, Mexico, 78250
    - Atea Study Site
- Yucatan
  - Yucatán, Yucatan, Mexico, 97070
    - Atea Study Site
Netherlands
- - Den Haag, Netherlands, 2565 KV
    - Atea Study Site
  - Den Haag, Netherlands, 2572
    - Atea Study Site
  - Utrecht, Netherlands, 3584
    - Atea Study Site
  - Zwijndrecht, Netherlands, 3333 GZ
    - Atea Study Site
  - Zwijndrecht, Netherlands, 3334 SB
    - Atea Study Site
Pakistan
- - Islamabad, Pakistan, 44000
    - Atea Study Site
  - Karachi, Pakistan, 74800
    - Atea Study Site
  - Karachi, Pakistan, 75600
    - Atea Study Site
  - Lahore, Pakistan, 53100
    - Atea Study Site
  - Rawalpindi, Pakistan, 44000
    - Atea Study Site
Philippines
- - Iloilo City, Philippines, 5000
    - Atea Study Site
  - Mandaluyong, Philippines, 1552
    - Atea Study Site
- Cordillera
  - Baguio City, Cordillera, Philippines, 2600
    - Atea Study Site
- Leyte
  - Tacloban City, Leyte, Philippines, 6500
    - Atea Study Site
- Manila
  - Ermita, Manila, Philippines
    - Atea Study Site
- Pampanga
  - San Fernando, Pampanga, Philippines
    - Atea Study Site
Romania
- - Baloteşti, Romania, 077015
    - Atea Study Site
  - Bucharest, Romania, 050159
    - Atea Study Site
  - Bucuresti, Romania, 022328
    - Atea Study Site
  - Bucuresti, Romania, 030303
    - Atea Study Site
  - Bucuresti, Romania, 21105
    - Atea Study Site
  - Constanţa, Romania, 900591
    - Atea Study Site
  - Craiova, Romania, 200515
    - Atea Study Site
  - Oradea, Romania, 410167
    - Atea Study Site
  - Sibiu, Romania, 550245
    - Atea Study Site
  - Suceava, Romania, 720201
    - Atea Study Site
  - Timişoara, Romania
    - Atea Study Site
South Africa
- Eastern Cape
  - East London, Eastern Cape, South Africa, 5219
    - Atea Study Site
- Gauteng
  - Johannesburg, Gauteng, South Africa, 1724
    - Atea Study Site
  - Pretoria, Gauteng, South Africa, 0184
    - Atea Study Site
  - Pretoria, Gauteng, South Africa, 181
    - Atea Study Site
  - Pretoria, Gauteng, South Africa, 183
    - Atea Study Site
  - Randburg, Gauteng, South Africa, 2087
    - Atea Study Site
- Limpopo
  - Thabazimbi, Limpopo, South Africa, 380
    - Atea Study Site
- Northern Cape
  - Kimberley, Northern Cape, South Africa, 8301
    - Atea Study Site
- Western Cape
  - Cape Town, Western Cape, South Africa, 7570
    - Atea Study Site
  - Plettenberg Bay, Western Cape, South Africa, 6600
    - Atea Study Site
Spain
- - Barcelona, Spain, 08028
    - Atea Study Site
  - Madrid, Spain, 28046
    - Atea Study Site
- Barcelona
  - Badalona, Barcelona, Spain, 8916
    - Atea Study Site
  - Centelles, Barcelona, Spain, 8540
    - Atea Study Site
- Malaga
  - Marbella, Malaga, Spain, 29603
    - Atea Study Site
  - Málaga, Malaga, Spain, 29014
    - Atea Study Site
Sweden
- - Solna, Sweden, 17164
    - Atea Study Site
  - Umeå, Sweden, 90185
    - Atea Study Site
Tunisia
- - La Marsa, Tunisia, 2070
    - Atea Study Site
  - Monastir, Tunisia, 5000
    - Atea Study Site
  - Montfleury, Tunisia, 1008
    - Atea Study Site
  - Sfax, Tunisia, 3000
    - Atea Study Site
  - Sousse, Tunisia, 4000
    - Atea Study Site
  - Sousse, Tunisia, 4011
    - Atea Study Site
  - Tunis, Tunisia, 1006
    - Atea Study Site
  - Tunis, Tunisia, 1029
    - Atea Study Site
Turkey
- - Ankara, Turkey, 06230
    - Atea Study Site
  - Ankara, Turkey, 6010
    - Atea Study Site
  - Ankara, Turkey, 6230
    - Atea Study Site
  - Ankara, Turkey, 6290
    - Atea Study Site
  - Ankara, Turkey, 6800
    - Atea Study Site
  - Antalya, Turkey, 7070
    - Atea Study Site
  - Antalya, Turkey, 7460
    - Atea Study Site
  - Bursa, Turkey, 16310
    - Atea Study Site
  - Denizli, Turkey, 20160
    - Atea Study Site
  - Istanbul, Turkey, 34093
    - Atea Study Site
  - Istanbul, Turkey, 34098
    - Atea Study Site
  - Istanbul, Turkey, 34722
    - Atea Study Site
  - Istanbul, Turkey, 34785
    - Atea Study Site
  - Istanbul, Turkey, 34844
    - Atea Study Site
  - Istanbul, Turkey, 34899
    - Atea Study Site
  - Kayseri, Turkey, 38080
    - Atea Study Site
  - Samsun, Turkey, 55270
    - Atea Study Site
  - Yenimahalle, Turkey, 06170
    - Atea Study Site
  - İzmir, Turkey, 35100
    - Atea Study Site
  - İzmir, Turkey, 35120
    - Atea Study Site
  - İzmir, Turkey, 35360
    - Atea Study Site
  - İzmir, Turkey, 35620
    - Atea Study Site
United Kingdom
- Devon
  - Exeter, Devon, United Kingdom, EX2 5DW
    - Atea Study Site
  - Plymouth, Devon, United Kingdom, PL6 8DH
    - Atea Study Site
- Greater London
  - London, Greater London, United Kingdom, N12 8BU
    - Atea Study Site
  - London, Greater London, United Kingdom, SE1 7EH
    - Atea Study Site
- West Yourkshire
  - Castleford, West Yourkshire, United Kingdom, WF10 2QP
    - Atea Study Site
United States
- Arizona
  - Kingman, Arizona, United States, 86401
    - Atea Study Site
  - Prescott, Arizona, United States, 86301
    - Atea Study Site
  - Surprise, Arizona, United States, 85378
    - Atea Study Site
  - Tucson, Arizona, United States, 85741
    - Atea Study Site
- California
  - Canoga Park, California, United States, 91303
    - Atea Study Site
  - Fullerton, California, United States, 92835
    - Atea Study Site
  - Inglewood, California, United States, 90301
    - Atea Study Site
  - La Palma, California, United States, 90623
    - Atea Study Site
  - Long Beach, California, United States, 90805
    - Atea Study Site
  - Long Beach, California, United States, 98015
    - Atea Study Site
  - Los Angeles, California, United States, 90017
    - Atea Study Site
  - Sacramento, California, United States, 95817
    - Atea Study Site
  - San Diego, California, United States, 92120
    - Atea Study Site
- Florida
  - Coral Gables, Florida, United States, 33134
    - Atea Study Site
  - Cutler Bay, Florida, United States, 33189
    - Atea Study Site
  - Doral, Florida, United States, 33172
    - Atea Study Site
  - Hialeah, Florida, United States, 33010
    - Atea Study Site
  - Miami, Florida, United States, 33125
    - Atea Study Site
  - Miami, Florida, United States, 33135
    - Atea Study Site
  - Miami, Florida, United States, 33155
    - Atea Study Site
  - Miami, Florida, United States, 33165
    - Atea Study Site
  - Miami, Florida, United States, 33173
    - Atea Study Site
  - Miami, Florida, United States, 33184
    - Atea Study Site
  - Miami, Florida, United States, 33186
    - Atea Study Site
  - Miami Gardens, Florida, United States, 33014
    - Atea Study Site
  - North Miami Beach, Florida, United States, 33162
    - Atea Study Site
  - North Miami Beach, Florida, United States, 33179
    - Atea Study Site
  - Pembroke Pines, Florida, United States, 33024
    - Atea Study Site
  - Pompano Beach, Florida, United States, 33164
    - Atea Study Site
  - Tampa, Florida, United States, 33607
    - Atea Study Site
  - Tampa, Florida, United States, 33612
    - Atea Study Site
  - Tampa, Florida, United States, 33614
    - Atea Study Site
  - Tampa, Florida, United States, 33615
    - Atea Study Site
  - The Villages, Florida, United States, 32162
    - Atea Study Site
  - W. Miami, Florida, United States, 33144
    - Atea Study Site
  - West Palm Beach, Florida, United States, 33409
    - Atea Study Site
- Georgia
  - Eatonton, Georgia, United States, 31024
    - Atea Study Site
- Illinois
  - Orland Park, Illinois, United States, 60462
    - Atea Study Site
- Nebraska
  - La Vista, Nebraska, United States, 68128
    - Atea Study Site
- New York
  - Bronx, New York, United States, 10456
    - Atea Study Site
  - Bronx, New York, United States, 10467
    - Atea Study Site
- North Carolina
  - Chapel Hill, North Carolina, United States, 27514
    - Atea Study Site
  - High Point, North Carolina, United States, 27260
    - Atea Study Site
- Oklahoma
  - Chickasha, Oklahoma, United States, 73018
    - Atea Study Site
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Atea Study Site
- South Carolina
  - Greenville, South Carolina, United States, 29615
    - Atea Study Site
  - Rock Hill, South Carolina, United States, 29732
    - Atea Study Site
- Texas
  - Carrollton, Texas, United States, 75006
    - Atea Study Site
  - Dallas, Texas, United States, 75230
    - Atea Study Site
  - DeSoto, Texas, United States, 75115
    - Atea Study Site
  - Forney, Texas, United States, 75126
    - Atea Study Site
  - Fort Worth, Texas, United States, 76164
    - Atea Study Site
  - Harlingen, Texas, United States, 78550
    - Atea Study Site
  - Houston, Texas, United States, 77065
    - Atea Study Site
  - Kingwood, Texas, United States, 77339
    - Atea Study Site
  - Lewisville, Texas, United States, 75057
    - Atea Study Site
  - Mesquite, Texas, United States, 75150
    - Atea Study Site
  - San Antonio, Texas, United States, 78215
    - Atea Study Site
  - Splendora, Texas, United States, 77372
    - Atea Study Site
  - Stafford, Texas, United States, 77477
    - Atea Study Site
  - Sugar Land, Texas, United States, 77479
    - Atea Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Placebo tablets administered orally every 12 hours (twice a day) for a total of 5 days
Experimental: Bemnifosbuvir (BEM)	Drug: Bemnifosbuvir (BEM) BEM tablets administered orally every 12 hours (twice a day) for a total of 5 days Other Names: AT-527

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Subjects Hospitalized for Any Cause or Died Due to Any Cause Time Frame: Day 1 through Day 29	Day 1 through Day 29

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Subjects Hospitalized Due to COVID-19 or Died Due to Any Cause Time Frame: Day 1 through Day 29	Day 1 through Day 29
Percentage of Subjects Who Died Due to Any Cause Time Frame: Day 1 through Day 29; Day 1 through Day 60	Day 1 through Day 29; Day 1 through Day 60
Percentage of Subjects With COVID-19-related Complications Time Frame: Day 1 through Day 29	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 Time Frame: Day 1 through Day 29; Day 1 through Day 60	Day 1 through Day 29; Day 1 through Day 60
Percentage of Subjects With COVID-19 Symptom Relapse Time Frame: Day 1 through Day 29	Day 1 through Day 29
Percentage of Subjects With Viral Load Rebound Time Frame: Day 1 through Day 29	Day 1 through Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atea Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2022

Primary Completion (Actual)

April 25, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

November 26, 2022

First Submitted That Met QC Criteria

November 26, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

May 29, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

AT-03A-017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on COVID-19

Clinical Trials on Bemnifosbuvir (BEM)

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Drug Interventions

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Conditions

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Drug Interventions

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Sponsor/Collaborators

Locations