Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2 Infection)Phase 3NCT05629962
SUNRISE-3: Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19
A Phase 3 study testing Bemnifosbuvir (BEM) in people with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2 Infection) and COVID-19, run by Atea Pharmaceuticals, Inc. at 263 sites in 19 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2 Infection), COVID-19
- What is being tested?
- Bemnifosbuvir (BEM)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,285 participants
- Where
- 263 sitesin 19 countries
- Study dates
- 25 Nov 2022to 30 May 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
263 sites in 19 countries.
263 sites in 19 countries
United States61 sites
Atea Study Site
Canoga Park, California, 91303
Atea Study Site
Carrollton, Texas, 75006
Atea Study Site
Chapel Hill, North Carolina, 27514
Atea Study Site
Chickasha, Oklahoma, 73018
Atea Study Site
Coral Gables, Florida, 33134
Atea Study Site
Cutler Bay, Florida, 33189
Atea Study Site
Dallas, Texas, 75230
Atea Study Site
DeSoto, Texas, 75115
Atea Study Site
Doral, Florida, 33172
Atea Study Site
Eatonton, Georgia, 31024
Atea Study Site
Forney, Texas, 75126
Atea Study Site
Fort Worth, Texas, 76164
Atea Study Site
Fullerton, California, 92835
Atea Study Site
Greenville, South Carolina, 29615
Atea Study Site
Harlingen, Texas, 78550
Atea Study Site
Hialeah, Florida, 33010
Atea Study Site
High Point, North Carolina, 27260
Atea Study Site
Houston, Texas, 77065
Atea Study Site
Inglewood, California, 90301
Atea Study Site
Kingman, Arizona, 86401
Atea Study Site
Kingwood, Texas, 77339
Atea Study Site
La Palma, California, 90623
Atea Study Site
La Vista, Nebraska, 68128
Atea Study Site
Lewisville, Texas, 75057
Atea Study Site
Long Beach, California, 90805
Atea Study Site
Long Beach, California, 98015
Atea Study Site
Los Angeles, California, 90017
Atea Study Site
Mesquite, Texas, 75150
Atea Study Site
Miami, Florida, 33125
Atea Study Site
Miami, Florida, 33135
Atea Study Site
Miami, Florida, 33155
Atea Study Site
Miami, Florida, 33165
Atea Study Site
Miami, Florida, 33173
Atea Study Site
Miami, Florida, 33184
Atea Study Site
Miami, Florida, 33186
Atea Study Site
Miami Gardens, Florida, 33014
Atea Study Site
North Miami Beach, Florida, 33162
Atea Study Site
North Miami Beach, Florida, 33179
Atea Study Site
Orland Park, Illinois, 60462
Atea Study Site
Pembroke Pines, Florida, 33024
Atea Study Site
Pompano Beach, Florida, 33164
Atea Study Site
Prescott, Arizona, 86301
Atea Study Site
Providence, Rhode Island, 02903
Atea Study Site
Rock Hill, South Carolina, 29732
Atea Study Site
Sacramento, California, 95817
Atea Study Site
San Antonio, Texas, 78215
Atea Study Site
San Diego, California, 92120
Atea Study Site
Splendora, Texas, 77372
Atea Study Site
Stafford, Texas, 77477
Atea Study Site
Sugar Land, Texas, 77479
Atea Study Site
Surprise, Arizona, 85378
Atea Study Site
Tampa, Florida, 33607
Atea Study Site
Tampa, Florida, 33612
Atea Study Site
Tampa, Florida, 33614
Atea Study Site
Tampa, Florida, 33615
Atea Study Site
The Bronx, New York, 10456
Atea Study Site
The Bronx, New York, 10467
Atea Study Site
The Villages, Florida, 32162
Atea Study Site
Tucson, Arizona, 85741
Atea Study Site
West Miami, Florida, 33144
Atea Study Site
West Palm Beach, Florida, 33409
Brazil44 sites
Atea Study Site
Barretos, São Paulo, 14784-400
Atea Study Site
Belo Horizonte, Minas Gerais, 30110-934
Atea Study Site
Belo Horizonte, Minas Gerais, 30150-221
Atea Study Site
Belo Horizonte, Minas Gerais, 30220-330
Atea Study Site
Bento Gonçalves, São Paulo, 95700-084
Atea Study Site
Blumenau, Santa Catarina, 89020-430
Atea Study Site
Botucatu, São Paulo, 18618-970
Atea Study Site
Brasília, Federal District, 70710-100
Atea Study Site
Cachoeiro de Itapemirim, Espírito Santo, 2938-020
Atea Study Site
Campina Grande do Sul, Paraná, 83430-000
Atea Study Site
Campinas, São Paulo, 13075
Atea Study Site
Cuiabá, Mato Grosso, 78048
Atea Study Site
Florianópolis, Santa Catarina, 88015
Atea Study Site
Fortaleza, Ceará, 60160-070
Atea Study Site
Fortaleza, Ceará, 60430-370
Atea Study Site
Ijuí, São Paulo, 98700-000
Atea Study Site
Itajaí, Santa Catarina, 88301-220
Atea Study Site
Itajaí, Santa Catarina, 88301-260
Atea Study Site
Jaú, São Paulo, 17210-120
Atea Study Site
Joinville, Santa Catarina, 89201
Atea Study Site
Maceió, Alagoas, 57052-580
Atea Study Site
Natal, Rio Grande do Norte, 59020-500
Atea Study Site
Natal, Rio Grande do Norte, 59025
Atea Study Site
Osasco, São Paulo, 06013-070
Atea Study Site
Passo Fundo, Rio Grande do Sul, 99010-260
Atea Study Site
Porto Alegre, Rio Grande do Sul, 90020-090
Atea Study Site
Porto Alegre, Rio Grande do Sul, 90035-004
Atea Study Site
Porto Alegre, Rio Grande do Sul, 90035-903
Atea Study Site
Porto Alegre, Rio Grande do Sul, 90610-000
Atea Study Site
Porto Velho, Rondônia, 78918-791
Atea Study Site
Ribeirão Preto, São Paulo, 14048-900
Atea Study Site
Rio de Janeiro, Rio Do Janeiro, 20241-180
Atea Study Site
Rio de Janeiro, 20241-180
Atea Study Site
Salvador, Estado de Bahia, 40050-410
Atea Study Site
Salvador, Estado de Bahia, 40150
Atea Study Site
Santa Catarina, São Paulo, 88811-000
Atea Study Site
São José do Rio Preto, São Paulo, 15090-000
Atea Study Site
São Paulo, São Paulo, 01509
Atea Study Site
São Paulo, São Paulo, 04038-002
Atea Study Site
São Paulo, São Paulo, 05403-000
Atea Study Site
São Paulo, São Paulo, 08270-120
Atea Study Site
Serra, Espírito Santo, 29101-850
Atea Study Site
Valinhos, São Paulo, 13271-130
Atea Study Site
Vitória, Espírito Santo, 29043-260
Turkey (Türkiye)22 sites
Atea Study Site
Ankara, 06230
Atea Study Site
Ankara, 6010
Atea Study Site
Ankara, 6230
Atea Study Site
Ankara, 6290
Atea Study Site
Ankara, 6800
Atea Study Site
Antalya, 7070
Atea Study Site
Antalya, 7460
Atea Study Site
Bursa, 16310
Atea Study SIte
Denizli, 20160
Atea Study Site
Istanbul, 34093
Atea Study Site
Istanbul, 34098
Atea Study Site
Istanbul, 34722
Atea Study Site
Istanbul, 34785
Atea Study Site
Istanbul, 34844
Atea Study Site
Istanbul, 34899
Atea Study Site
Izmir, 35100
Atea Study Site
Izmir, 35120
Atea Study Site
Izmir, 35360
Atea Study Site
Izmir, 35620
Atea Study SIte
Kayseri, 38080
Atea Study Site
Samsun, 55270
Atea Study Site
Yenimahalle, 06170
India21 sites
Atea Study Site
Ahmedabad, Gujarat, 380006
Atea Study Site
Bangalore, Karnataka, 560049
Atea Study Site
Bangalore, Karnataka, 560060
Atea Study Site
Bangalore, Karnataka, 560076
Atea Study Site
Bengaluru, Karnataka, 560068
Atea Study Site
Chennai, Tamil Nadu, 600113
Atea Study Site
Dombivali, Maharashtra, 421203
Atea Study Site
Faridabad, Haryana, 121001
Atea Study Site
Gotri, Gujarat, 390021
Atea Study Site
Hyderabad, Andhra Pradesh, 500018
Atea Study Site
Jaipur, Rajasthan, 302020
Atea Study Site
Jaipur, Rajasthan, 30217
Atea Study Site
Nashik, Maharashtra, 422005
Atea Study Site
Nashik, Maharashtra, 422007
Atea Study Site
Nellore, Andhra Pradesh, 524001
Atea Study Site
Nellore, Andhra Prasesh, 524001
Atea Study Site
New Delhi, National Capital Territory of Delhi, 110075
Atea Study Site
Pune, Maharashtra, 411023
Atea Study Site
Surat, Gujarat, 395004
Atea Study Site
Surat, Gujarat, 395010
Atea Study Site
Visakhapatnam, Andhra Pradesh, 530002
Mexico18 sites
Atea Study Site
Cancún, Quintana Roo, 77500
Atea Study Site
Chihuahua City, 31203
Atea Study Site
Guadalajara, Jalisco, 44180
Atea Study Site
Mexico City, Mexico City, 06700
Atea Study Site
Monterrey, Nuevo León, 64060
Atea Study Site
Monterrey, Nuevo León, 64310
Atea Study Site
Monterrey, Nuevo León, 64320
Atea Study Site
Monterrey, Nuevo León, 64460
Atea Study Site
Monterrey, Nuevo León, 64710
Atea Study Site
Oaxaca City, 68000
Atea Study Site
Puebla City, 72180
Atea Study Site
Querétaro City, Querétaro, 76100
Atea Study Site
Saltillo, Coahuila, 25020
Atea Study site
San Luis Potosí City, San Luis Potos, 78250
Atea Study Site
Torreón, Coahuila, 27010
Atea Study Site
Veracruz, 91851
Atea Study Site
Veracruz, 91900
Atea Study Site
Yucatán, Yucatán, 97070
Japan16 sites
Atea Study Site
Chiba, 260-0852
Atea Study Site
Fujisawa, Kanagawa, 251-0041
Atea Study Site
Fukuoka, Fukuoka, 810-0033
Atea Study Site
Fukuoka, Fukuoka City, 819-0015
Atea Study Site
Fukuoka, 814-0153
Atea Study Site
Himeji, Hyōgo, 670-0849
Atea Study Site
Izumisano, Osaka, 598-8577
Atea Study Site
Kamakura, Kanagawa, 247-8533
Atea Study Site
Kanazawa, Ishikawa-ken, 920-8650
Atea Study Site
Kasuga, Fukuoka, 816-0842
Atea Study Site
Kitakyushu, Fukuoka, 807-0072
Atea Study Site
Okayama, 700-8557
Atea Study Site
Sapporo, Hokkaido, 065-0033
Atea Study Site
Toda, Saitama, 335-0035
Atea Study Site
Tsuchiura, Ibaraki, 300-0062
Atea Study Site
Uozu, Toyama, 937-0042
Argentina15 sites
Atea Study Site
Bahía Blanca, Buenos Aires, B800FTD
Atea Study Site
Buenos Aires, Ciudad Autonoma Buenos Aires, C1180AAX
Atea Study Site
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1056ABJ
Atea Study Site
Ciudad Autonoma de Buenos Aire, C1202ABB
Atea Study Site
Córdoba, Córdoba Province, 5000
Atea Study Site
Córdoba, CPX5000EPU
Atea Study Site
Mar del Plata, Buenos Aires, B7600FYK
Atea Study Site
Mar del Plata, Buenos Aires, B7602DCK
Atea Study Site
Ramos Mejía, Buenos Aires, 1704
Atea Study Site
Rosario, Santa Fe Province, 2000
Atea Study Site
Rosario, Santa Fe Province, S2000PBJ
Atea Study Site
San Miguel de Tucumán, Tucumán Province, 4000
Atea Study Site
San Miguel de Tucumán, Tucumán Province, T4000AXL
Atea Study Site
San Nicolás de los Arroyos, Buenos Aires, B2900DMH
Atea Study Site
Santiago del Estero, 4200
Romania11 sites
Atea Study Site
Baloteşti, 077015
Atea Study Site
Bucharest, 022328
Atea Study Site
Bucharest, 030303
Atea Study Site
Bucharest, 050159
Atea Study Site
Bucharest, 21105
Atea Study Site
Constanța, 900591
Atea Study Site
Craiova, 200515
Atea Study Site
Oradea, 410167
Atea Study Site
Sibiu, 550245
Atea Study Site
Suceava, 720201
Atea Study Site
Timișoara
South Africa10 sites
Atea Study Site
Cape Town, Western Cape, 7570
Atea Study Site
East London, Eastern Cape, 5219
Atea Study Site
Johannesburg, Gauteng, 1724
Atea Study Site
Kimberley, Northern Cape, 8301
Atea Study Site
Plettenberg Bay, Western Cape, 6600
Atea Study Site
Pretoria, Gauteng, 0184
Atea Study Site
Pretoria, Gauteng, 181
Atea Study Site
Pretoria, Gauteng, 183
Atea Study Site
Randburg, Gauteng, 2087
Atea Study Site
Thabazimbi, Limpopo, 380
Tunisia8 sites
Atea Study Site
La Marsa, 2070
Atea Study Site
Monastir, 5000
Atea Study Site
Montfleury, 1008
Atea Study Site
Sfax, 3000
Atea Study Site
Sousse, 4000
Atea Study Site
Sousse, 4011
Atea Study Site
Tunis, 1006
Atea Study Site
Tunis, 1029
Philippines6 sites
Atea Study Site
Baguio City, Cordillera, 2600
Atea Study Site
Ermita, Manila
Atea Study Site
Iloilo City, 5000
Atea Study Site
Mandaluyong, 1552
Atea Study Site
San Fernando City, Pampanga
Atea Study Site
Tacloban City, Leyte, 6500
Spain6 sites
Atea Study Site
Badalona, Barcelona, 8916
Atea Study Site
Barcelona, 08028
Atea Study Site
Centelles, Barcelona, 8540
Atea Study Site
Madrid, 28046
Atea Study Site
Málaga, Malaga, 29014
Atea Study Site
Marbella, Malaga, 29603
Netherlands5 sites
Atea Study Site
The Hague, 2565 KV
Atea Study Site
The Hague, 2572
Atea Study Site
Utrecht, 3584
Atea Study Site
Zwijndrecht, 3333 GZ
Atea Study Site
Zwijndrecht, 3334 SB
Pakistan5 sites
Atea Study Site
Islamabad, 44000
Atea Study Site
Karachi, 74800
Atea Study Site
Karachi, 75600
Atea Study Site
Lahore, 53100
Atea Study Site
Rawalpindi, 44000
United Kingdom5 sites
Atea Study Site
Castleford, West Yourkshire, WF10 2QP
Atea Study Site
Exeter, Devon, EX2 5DW
Atea Study Site
London, Greater London, N12 8BU
Atea Study Site
London, Greater London, SE1 7EH
Atea Study Site
Plymouth, Devon, PL6 8DH
Germany4 sites
Atea Study Site
Berlin, 13353
Atea Study Site
Frankfurt am Main, Hesse, 60596
Atea Study Site
Hamburg, 22143
Atea Study Site
Munich, Bavaria, 80336
Canada2 sites
Atea Study Site
Chicoutimi, Quebec, G7H 7Y8
Atea Study Site
Edmonton, Alberta, T5A 4L8
About this study
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
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.
- Being tested
- Bemnifosbuvir (BEM), Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bemnifosbuvir (BEM)Drug
Also called AT-527
BEM tablets administered orally every 12 hours (twice a day) for a total of 5 days
PlaceboDrug
Placebo tablets administered orally every 12 hours (twice a day) for a total of 5 days
| Study group | Role | What they receive |
|---|---|---|
| Bemnifosbuvir (BEM) | Experimental | Not described Receives: Drug: Bemnifosbuvir (BEM) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Hospitalized for Any Cause or Died Due to Any Cause
Measured: Day 1 through Day 29
Secondary outcomes (6)
Percentage of Subjects Hospitalized Due to COVID-19 or Died Due to Any Cause
Measured: Day 1 through Day 29
Percentage of Subjects Who Died Due to Any Cause
Measured: Day 1 through Day 29; Day 1 through Day 60
Percentage of Subjects With COVID-19-related Complications
Measured: 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
Measured: Day 1 through Day 29; Day 1 through Day 60
Percentage of Subjects With COVID-19 Symptom Relapse
Measured: Day 1 through Day 29
Percentage of Subjects With Viral Load Rebound
Measured: Day 1 through Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start25 Nov 2022
- Primary completion25 Apr 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2 Infection)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2,285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629962
- Sponsor's protocol ID
- AT-03A-017
- Status last verified
- May 2025
- First submitted
- 26 Nov 2022
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No