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

Last updated: May 29, 2025
Sponsor: Atea Pharmaceuticals, Inc.
Overall Status: Completed

Phase

3

Condition

Covid-19

Treatment

Bemnifosbuvir (BEM)

Placebo

Clinical Study ID

NCT05629962
AT-03A-017
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 atleast 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] ≥30kg/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 lungdisease 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 followingimmunocompromising conditions or immunosuppressive treatments: receivingchemotherapy for cancer, hematologic malignancy, being within 2 years of ahematopoietic stem cell transplant, receipt of a solid organ transplant and onimmunosuppressive therapy, human immunodeficiency virus (HIV) infectionuntreated 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

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 plansto enroll in another clinical trial of an investigational agent while participatingin the present study

  • Initiation or planned initiation of remdesivir for treatment of the currentSARS-CoV-2 infection

  • Requirement of prohibited medications, including hydroxychloroquine or amiodaronewithin 3 months prior to screening. Note: Subjects who had already initiated anyCOVID-19 drug with antiviral effects intended to treat symptomatic SARS-CoV-2infection (≥ 24 hours prior to randomization) will be excluded. During screening (orwithin 24 hours prior to or after randomization), locally available COVID-19 drugswith 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 asinfluenza and respiratory syncytial virus (RSV). Note: This exclusion does not applyto 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 Design

Total Participants: 2285
Treatment Group(s): 2
Primary Treatment: Bemnifosbuvir (BEM)
Phase: 3
Study Start date:
November 25, 2022
Estimated Completion Date:
May 30, 2024

Connect with a study center

  • Atea Study Site

    Bahía Blanca, Buenos Aires B800FTD
    Argentina

    Site Not Available

  • Atea Study Site

    Ciudad Autonoma de Buenos Aire, Buenos Aires C1056ABJ
    Argentina

    Site Not Available

  • Atea Study Site

    Mar Del Plata, Buenos Aires B7602DCK
    Argentina

    Site Not Available

  • Atea Study Site

    Ramos Mejía, Buenos Aires 1704
    Argentina

    Site Not Available

  • Atea Study Site

    San Nicolas, Buenos Aires B2900DMH
    Argentina

    Site Not Available

  • Atea Study Site

    Buenos Aires, Ciudad Autonoma Buenos Aires C1180AAX
    Argentina

    Site Not Available

  • Atea Study Site

    Córdoba, Cordoba 5000
    Argentina

    Site Not Available

  • Atea Study Site

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Atea Study Site

    San Miguel De Tucumán, Tucuman 4000
    Argentina

    Site Not Available

  • Atea Study Site

    Tucumán, Tucuman 4000
    Argentina

    Site Not Available

  • Atea Study Site

    Santiago Del Estero, 4200
    Argentina

    Site Not Available

  • Atea Study Site

    Maceió, Alagoas 57052-580
    Brazil

    Site Not Available

  • Atea Study Site

    Salvador, Bahia 40050-410
    Brazil

    Site Not Available

  • Atea Study Site

    Fortaleza, Ceara 60160-070
    Brazil

    Site Not Available

  • Atea Study Site

    Brasília, Distrito Federal 70710-100
    Brazil

    Site Not Available

  • Atea Study Site

    Cachoeiro De Itapemirim, Espirito Santo 2938-020
    Brazil

    Site Not Available

  • Atea Study Site

    Serra, Espirito Santo 29101-850
    Brazil

    Site Not Available

  • Atea Study Site

    Vitória, Espirito Santo 29043-260
    Brazil

    Site Not Available

  • Atea Study Site

    Cuiabá, Mato Grosso 78048
    Brazil

    Site Not Available

  • Atea Study Site

    Belo Horizonte, Minas Gerais 30110-934
    Brazil

    Site Not Available

  • Atea Study Site

    Campina Grande Do Sul, Parana 83430-000
    Brazil

    Site Not Available

  • Atea Study Site

    Rio De Janeiro, Rio Do Janeiro 20241-180
    Brazil

    Site Not Available

  • Atea Study Site

    Natal, Rio Grande Do Norte 59020-500
    Brazil

    Site Not Available

  • Atea Study Site

    Passo Fundo, Rio Grande Do Sul 99010-260
    Brazil

    Site Not Available

  • Atea Study Site

    Porto Alegre, Rio Grande Do Sul 90035-903
    Brazil

    Site Not Available

  • Atea Study Site

    Porto Velho, Rondonia 78918-791
    Brazil

    Site Not Available

  • Atea Study Site

    Blumenau, Santa Catarina 89020-430
    Brazil

    Site Not Available

  • Atea Study Site

    Florianópolis, Santa Catarina 88015
    Brazil

    Site Not Available

  • Atea Study Site

    Itajaí, Santa Catarina 88301-220
    Brazil

    Site Not Available

  • Atea Study Site

    Joinville, Santa Catarina 89201
    Brazil

    Site Not Available

  • Atea Study Site

    Barretos, Sao Paulo 14784-400
    Brazil

    Site Not Available

  • Atea Study Site

    Bento Gonçalves, Sao Paulo 95700-084
    Brazil

    Site Not Available

  • Atea Study Site

    Botucatu, Sao Paulo 18618-970
    Brazil

    Site Not Available

  • Atea Study Site

    Campinas, Sao Paulo 13075
    Brazil

    Site Not Available

  • Atea Study Site

    Ijuí, Sao Paulo 98700-000
    Brazil

    Site Not Available

  • Atea Study Site

    Jaú, Sao Paulo 17210-120
    Brazil

    Site Not Available

  • Atea Study Site

    Osasco, Sao Paulo 06013-070
    Brazil

    Site Not Available

  • Atea Study Site

    Ribeirão Preto, Sao Paulo 14048-900
    Brazil

    Site Not Available

  • Atea Study Site

    Santa Catarina, Sao Paulo 88811-000
    Brazil

    Site Not Available

  • Atea Study Site

    São José Do Rio Preto, Sao Paulo 15090-000
    Brazil

    Site Not Available

  • Atea Study Site

    São Paulo, Sao Paulo 01509
    Brazil

    Site Not Available

  • Atea Study Site

    Valinhos, São Paulo 13271-130
    Brazil

    Site Not Available

  • Atea Study Site

    Edmonton, Alberta T5A 4L8
    Canada

    Site Not Available

  • Atea Study Site

    Chicoutimi, Quebec G7H 7Y8
    Canada

    Site Not Available

  • Atea Study Site

    Muenchen, Bayern 80336
    Germany

    Site Not Available

  • Atea Study Site

    Frankfurt am Main, Hessen 60596
    Germany

    Site Not Available

  • Atea Study Site

    Berlin, 13353
    Germany

    Site Not Available

  • Atea Study Site

    Hamburg, 22143
    Germany

    Site Not Available

  • Atea Study Site

    Hyderabad, Andhra Pradesh 500018
    India

    Site Not Available

  • Atea Study Site

    Nellore, Andhra Pradesh 524001
    India

    Site Not Available

  • Atea Study Site

    Visakhapatnam, Andhra Pradesh 530002
    India

    Site Not Available

  • Atea Study Site

    New Delhi, Delhi 110075
    India

    Site Not Available

  • Atea Study Site

    Ahmedabad, Gujarat 380006
    India

    Site Not Available

  • Atea Study Site

    Gotri, Gujarat 390021
    India

    Site Not Available

  • Atea Study Site

    Sūrat, Gujarat 395004
    India

    Site Not Available

  • Atea Study Site

    Faridabad, Haryana 121001
    India

    Site Not Available

  • Atea Study Site

    Bangalore, Karnataka 560049
    India

    Site Not Available

  • Atea Study Site

    Bengaluru, Karnataka 560068
    India

    Site Not Available

  • Atea Study Site

    Dombivli, Maharashtra 421203
    India

    Site Not Available

  • Atea Study Site

    Nashik, Maharashtra 422007
    India

    Site Not Available

  • Atea Study Site

    Pune, Maharashtra 411023
    India

    Site Not Available

  • Atea Study Site

    Jaipur, Rajasthan 30217
    India

    Site Not Available

  • Atea Study Site

    Chennai, Tamilnadu 600113
    India

    Site Not Available

  • Atea Study Site

    Agra, Uttar Prade 282003
    India

    Site Not Available

  • Atea Study Site

    Chuo, Chiba 260-0852
    Japan

    Site Not Available

  • Atea Study Site

    Kasuga, Fukuoka 816-0842
    Japan

    Site Not Available

  • Atea Study Site

    Nishi-ku, Fukuoka City 819-0015
    Japan

    Site Not Available

  • Atea Study Site

    Fukuoka-Shi, Fukuoka-Ken 810-0033
    Japan

    Site Not Available

  • Atea Study Site

    Kitakyushu, Fukuoka-Ken 807-0072
    Japan

    Site Not Available

  • Atea Study Site

    Sapporo, Hokkaido 065-0033
    Japan

    Site Not Available

  • Atea Study Site

    Himeji, Hyogo 670-0849
    Japan

    Site Not Available

  • Atea Study Site

    Tsuchiura, Ibaraki 300-0062
    Japan

    Site Not Available

  • Atea Study Site

    Tsuchiura-shi, Ibaraki 300-0062
    Japan

    Site Not Available

  • Atea Study Site

    Tsukuba, Ibaraki 300
    Japan

    Site Not Available

  • Atea Study Site

    Kanazawa, Ishikawa 920-8650
    Japan

    Site Not Available

  • Atea Study Site

    Fujisawa, Kanagawa 251-0041
    Japan

    Site Not Available

  • Atea Study Site

    Kamakura, Kanagawa 247-8533
    Japan

    Site Not Available

  • Atea Study Site

    Izumisano, Osaka 598-8577
    Japan

    Site Not Available

  • Atea Study Site

    Toda, Saitama 335-0035
    Japan

    Site Not Available

  • Atea Study Site

    Uozu, Toyama 937-0042
    Japan

    Site Not Available

  • Atea Study Site

    Chiba, 260-0852
    Japan

    Site Not Available

  • Atea Study Site

    Fukuoka, 814-0153
    Japan

    Site Not Available

  • Atea Study Site

    Okayama, 700-8557
    Japan

    Site Not Available

  • Atea Study Site

    Toyama, 930-0152
    Japan

    Site Not Available

  • Atea Study Site

    Daugavpils, LV-5410
    Latvia

    Site Not Available

  • Atea Study Site

    Riga, LV-1010
    Latvia

    Site Not Available

  • Atea Study Site

    Saltillo, Coahuila 25020
    Mexico

    Site Not Available

  • Atea Study Site

    Torreon, Coahuila 27010
    Mexico

    Site Not Available

  • Atea Study Site

    Mexico, Distrito Federal 06700
    Mexico

    Site Not Available

  • Atea Study Site

    Guadalajara, Jalisco 44180
    Mexico

    Site Not Available

  • Atea Study Site

    Ciudad de mexico, Mexico City 06700
    Mexico

    Site Not Available

  • Atea Study Site

    Cuauhtémoc, Mexico City 06700
    Mexico

    Site Not Available

  • Atea Study Site

    Monterrey, Nuevo Leon 64460
    Mexico

    Site Not Available

  • Atea Study Site

    San Pedro Garza Garcia, Nuevo Leon 66278
    Mexico

    Site Not Available

  • Atea Study Site

    Querétaro, Queretaro 76100
    Mexico

    Site Not Available

  • Atea Study Site

    Cancún, Quintana Roo 77500
    Mexico

    Site Not Available

  • Atea Study site

    San Luis Potosí, San Luis Potos 78250
    Mexico

    Site Not Available

  • Atea Study Site

    Yucatán, Yucatan 97070
    Mexico

    Site Not Available

  • Atea Study Site

    Chihuahua, 31203
    Mexico

    Site Not Available

  • Atea Study Site

    Mexico City, 6700
    Mexico

    Site Not Available

  • Atea Study Site

    Oaxaca, 68000
    Mexico

    Site Not Available

  • Atea Study Site

    Puebla, 72180
    Mexico

    Site Not Available

  • Atea Study Site

    Veracruz, 91900
    Mexico

    Site Not Available

  • Atea Study Site

    Den Haag, 2572
    Netherlands

    Site Not Available

  • Atea Study Site

    Utrecht, 3584
    Netherlands

    Site Not Available

  • Atea Study Site

    Zwijndrecht, 3333 GZ
    Netherlands

    Site Not Available

  • Atea Study Site

    Islamabad, 44000
    Pakistan

    Site Not Available

  • Atea Study Site

    Karachi, 75600
    Pakistan

    Site Not Available

  • Atea Study Site

    Lahore, 53100
    Pakistan

    Site Not Available

  • Atea Study Site

    Rawalpindi, 44000
    Pakistan

    Site Not Available

  • Atea Study Site

    Dasmariñas, Cavite 4114
    Philippines

    Site Not Available

  • Atea Study Site

    Baguio City, Cordillera 2600
    Philippines

    Site Not Available

  • Atea Study Site

    Tacloban City, Leyte 6500
    Philippines

    Site Not Available

  • Atea Study Site

    Ermita, Manila
    Philippines

    Site Not Available

  • Atea Study Site

    San Fernando, Pampanga
    Philippines

    Site Not Available

  • Atea Study Site

    Iloilo City, 5000
    Philippines

    Site Not Available

  • Atea Study Site

    Mandaluyong, 1552
    Philippines

    Site Not Available

  • Atea Study Site

    Baloteşti, 077015
    Romania

    Site Not Available

  • Atea Study Site

    Bucharest, 050159
    Romania

    Site Not Available

  • Atea Study Site

    Bucuresti, 21105
    Romania

    Site Not Available

  • Atea Study Site

    Constanţa, 900591
    Romania

    Site Not Available

  • Atea Study Site

    Craiova, 200515
    Romania

    Site Not Available

  • Atea Study Site

    Oradea, 410167
    Romania

    Site Not Available

  • Atea Study Site

    Sibiu, 550245
    Romania

    Site Not Available

  • Atea Study Site

    Suceava, 720201
    Romania

    Site Not Available

  • Atea Study Site

    Timişoara,
    Romania

    Site Not Available

  • Atea Study Site

    East London, Eastern Cape 5219
    South Africa

    Site Not Available

  • Atea Study Site

    Johannesburg, Gauteng 1724
    South Africa

    Site Not Available

  • Atea Study Site

    Pretoria, Gauteng 183
    South Africa

    Site Not Available

  • Atea Study Site

    Randburg, Gauteng 2087
    South Africa

    Site Not Available

  • Atea Study Site

    Thabazimbi, Limpopo 380
    South Africa

    Site Not Available

  • Atea Study Site

    Kimberley, Northern Cape 8301
    South Africa

    Site Not Available

  • Atea Study Site

    Cape Town, Western Cape 7570
    South Africa

    Site Not Available

  • Atea Study Site

    Plettenberg Bay, Western Cape 6600
    South Africa

    Site Not Available

  • Atea Study Site

    Badalona, Barcelona 8916
    Spain

    Site Not Available

  • Atea Study Site

    Centelles, Barcelona 8540
    Spain

    Site Not Available

  • Atea Study Site

    Marbella, Malaga 29603
    Spain

    Site Not Available

  • Atea Study Site

    Málaga, Malaga 29014
    Spain

    Site Not Available

  • Atea Study Site

    Barcelona, 08028
    Spain

    Site Not Available

  • Atea Study Site

    Madrid, 28046
    Spain

    Site Not Available

  • Atea Study Site

    Solna, 17164
    Sweden

    Site Not Available

  • Atea Study Site

    Umeå, 90185
    Sweden

    Site Not Available

  • Atea Study Site

    Ariana, 2080
    Tunisia

    Site Not Available

  • Atea Study Site

    La Marsa, 2070
    Tunisia

    Site Not Available

  • Atea Study Site

    Monastir, 5000
    Tunisia

    Site Not Available

  • Atea Study Site

    Montfleury, 1008
    Tunisia

    Site Not Available

  • Atea Study Site

    Sfax, 3000
    Tunisia

    Site Not Available

  • Atea Study Site

    Sousse, 4000
    Tunisia

    Site Not Available

  • Atea Study Site

    Tunis, 1029
    Tunisia

    Site Not Available

  • Atea Study Site

    Ankara, 6800
    Turkey

    Site Not Available

  • Atea Study Site

    Antalya, 7460
    Turkey

    Site Not Available

  • Atea Study Site

    Bursa, 16310
    Turkey

    Site Not Available

  • Atea Study SIte

    Denizli, 20160
    Turkey

    Site Not Available

  • Atea Study Site

    Istanbul, 34093
    Turkey

    Site Not Available

  • Atea Study SIte

    Kayseri, 38080
    Turkey

    Site Not Available

  • Atea Study Site

    Samsun, 55270
    Turkey

    Site Not Available

  • Atea Study Site

    Yenimahalle, 06170
    Turkey

    Site Not Available

  • Atea Study Site

    İzmir, 35120
    Turkey

    Site Not Available

  • Atea Study Site

    Exeter, Devon EX2 5DW
    United Kingdom

    Site Not Available

  • Atea Study Site

    Plymouth, Devon PL6 8DH
    United Kingdom

    Site Not Available

  • Atea Study Site

    London, Greater London N12 8BU
    United Kingdom

    Site Not Available

  • Atea Study Site

    Castleford, West Yourkshire WF10 2QP
    United Kingdom

    Site Not Available

  • Atea Study Site

    Kingman, Arizona 86401
    United States

    Site Not Available

  • Atea Study Site

    Prescott, Arizona 86301
    United States

    Site Not Available

  • Atea Study Site

    Surprise, Arizona 85378
    United States

    Site Not Available

  • Atea Study Site

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Atea Study Site

    Canoga Park, California 91303
    United States

    Site Not Available

  • Atea Study Site

    Fullerton, California 92835
    United States

    Site Not Available

  • Atea Study Site

    Inglewood, California 90301
    United States

    Site Not Available

  • Atea Study Site

    La Palma, California 90623
    United States

    Site Not Available

  • Atea Study Site

    Long Beach, California 90805
    United States

    Site Not Available

  • Atea Study Site

    Los Angeles, California 90017
    United States

    Site Not Available

  • Atea Study Site

    Sacramento, California 95817
    United States

    Site Not Available

  • Atea Study Site

    San Diego, California 92120
    United States

    Site Not Available

  • Atea Study Site

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Atea Study Site

    Cutler Bay, Florida 33189
    United States

    Site Not Available

  • Atea Study Site

    Doral, Florida 33172
    United States

    Site Not Available

  • Atea Study Site

    Hialeah, Florida 33010
    United States

    Site Not Available

  • Atea Study Site

    Miami, Florida 33173
    United States

    Site Not Available

  • Atea Study Site

    Miami Gardens, Florida 33014
    United States

    Site Not Available

  • Atea Study Site

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Atea Study Site

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • Atea Study Site

    Pompano Beach, Florida 33164
    United States

    Site Not Available

  • Atea Study Site

    Tampa, Florida 33607
    United States

    Site Not Available

  • Atea Study Site

    The Villages, Florida 32162
    United States

    Site Not Available

  • Atea Study Site

    W. Miami, Florida 33144
    United States

    Site Not Available

  • Atea Study Site

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Atea Study Site

    Eatonton, Georgia 31024
    United States

    Site Not Available

  • Atea Study Site

    Orland Park, Illinois 60462
    United States

    Site Not Available

  • Atea Study Site

    La Vista, Nebraska 68128
    United States

    Site Not Available

  • Atea Study Site

    Bronx, New York 10467
    United States

    Site Not Available

  • Atea Study Site

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Atea Study Site

    High Point, North Carolina 27260
    United States

    Site Not Available

  • Atea Study Site

    Chickasha, Oklahoma 73018
    United States

    Site Not Available

  • Atea Study Site

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Atea Study Site

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Atea Study Site

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • Atea Study Site

    Carrollton, Texas 75006
    United States

    Site Not Available

  • Atea Study Site

    Dallas, Texas 75230
    United States

    Site Not Available

  • Atea Study Site

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Atea Study Site

    Forney, Texas 75126
    United States

    Site Not Available

  • Atea Study Site

    Fort Worth, Texas 76164
    United States

    Site Not Available

  • Atea Study Site

    Harlingen, Texas 78550
    United States

    Site Not Available

  • Atea Study Site

    Houston, Texas 77065
    United States

    Site Not Available

  • Atea Study Site

    Kingwood, Texas 77339
    United States

    Site Not Available

  • Atea Study Site

    Lewisville, Texas 75057
    United States

    Site Not Available

  • Atea Study Site

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Atea Study Site

    Red Oak, Texas 75154
    United States

    Site Not Available

  • Atea Study Site

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Atea Study Site

    Splendora, Texas 77372
    United States

    Site Not Available

  • Atea Study Site

    Stafford, Texas 77477
    United States

    Site Not Available

  • Atea Study Site

    Sugar Land, Texas 77479
    United States

    Site Not Available

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