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CompletedNCT05629962Updated Jun 13, 2025Results posted

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

A Phase 3 interventional study of Bemnifosbuvir (BEM) and Placebo in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2 Infection) and COVID-19, sponsored by Atea Pharmaceuticals, Inc.. Completed at 264 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by Atea Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,285
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2 Infection)
  • COVID-19
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 2,285 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Atea Pharmaceuticals, Inc. is the lead sponsor of 33 studies on the registry; 2 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 4 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
2,285 participants (actual)

Study arms

  • Experimental
    Bemnifosbuvir (BEM)

    Drug: Bemnifosbuvir (BEM)

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugBemnifosbuvir (BEM)

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

    Also known as: AT-527

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Percentage of Subjects Hospitalized for Any Cause or Died Due to Any Cause

    Time frame: Day 1 through Day 29

Secondary outcomes

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

    Time frame: Day 1 through Day 29

  2. Percentage of Subjects Who Died Due to Any Cause

    Time frame: Day 1 through Day 29; Day 1 through Day 60

  3. Percentage of Subjects With COVID-19-related Complications

    Time frame: Day 1 through Day 29

  4. 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

  5. Percentage of Subjects With COVID-19 Symptom Relapse

    Time frame: Day 1 through Day 29

  6. Percentage of Subjects With Viral Load Rebound

    Time frame: Day 1 through Day 29

07

Results

Posted Jun 13, 2025
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.

Participant flow

Through Day 29
Participant flow — Through Day 29
MilestoneBEM - SCO StratumPBO - SCO StratumBEM - Combo StratumPBO - Combo Stratum
Started110411073836
Completed107310873735
Not completed312011
Day 30 Through Day 60
Participant flow — Day 30 Through Day 60
MilestoneBEM - SCO StratumPBO - SCO StratumBEM - Combo StratumPBO - Combo Stratum
Started107310873735
Completed107110833735
Not completed2400

Outcome measures

PrimaryPercentage of Subjects Hospitalized for Any Cause or Died Due to Any Cause
Time frame:
Day 1 through Day 29
Reported as:
Count of participants · Participants
Percentage of Subjects Hospitalized for Any Cause or Died Due to Any Cause
ParticipantsBEM - SCO StratumPBO - SCO StratumBEM - Combo StratumPBO - Combo Stratum
Percentage of Subjects Hospitalized for Any Cause or Died Due to Any Cause7200
Statistical analysis
  • BEM - SCO Stratum vs PBO - SCO Stratum · Cochran-Mantel-Haenszel · p = 0.954
SecondaryPercentage of Subjects Hospitalized Due to COVID-19 or Died Due to Any Cause
Time frame:
Day 1 through Day 29
Reported as:
Count of participants · Participants
Percentage of Subjects Hospitalized Due to COVID-19 or Died Due to Any Cause
ParticipantsBEM - SCO StratumPBO - SCO StratumBEM - Combo StratumPBO - Combo Stratum
Percentage of Subjects Hospitalized Due to COVID-19 or Died Due to Any Cause4200
SecondaryPercentage of Subjects Who Died Due to Any Cause
Time frame:
Day 1 through Day 29; Day 1 through Day 60
Reported as:
Count of participants · Participants
Percentage of Subjects Who Died Due to Any Cause
ParticipantsBEM - SCO StratumPBO - SCO StratumBEM - Combo StratumPBO - Combo Stratum
Through Day 292100
Through Day 603100
SecondaryPercentage of Subjects With COVID-19-related Complications
Time frame:
Day 1 through Day 29
Reported as:
Count of participants · Participants
Percentage of Subjects With COVID-19-related Complications
ParticipantsBEM - SCO StratumPBO - SCO StratumBEM - Combo StratumPBO - Combo Stratum
Percentage of Subjects With COVID-19-related Complications3400
SecondaryPercentage 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
Reported as:
Count of participants · Participants
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
ParticipantsBEM - SCO StratumPBO - SCO StratumBEM - Combo StratumPBO - Combo Stratum
Through Day 2971110
Through Day 6081210
SecondaryPercentage of Subjects With COVID-19 Symptom Relapse
Time frame:
Day 1 through Day 29
Reported as:
Count of participants · Participants
Percentage of Subjects With COVID-19 Symptom Relapse
ParticipantsBEM - SCO StratumPBO - SCO StratumBEM - Combo StratumPBO - Combo Stratum
Percentage of Subjects With COVID-19 Symptom Relapse2722651312
SecondaryPercentage of Subjects With Viral Load Rebound
Time frame:
Day 1 through Day 29
Reported as:
Count of participants · Participants
Percentage of Subjects With Viral Load Rebound
ParticipantsBEM - SCO StratumPBO - SCO StratumBEM - Combo StratumPBO - Combo Stratum
Percentage of Subjects With Viral Load Rebound7910245

Adverse events

Collected over Through Day 60. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BEM - SCO Stratum3/1,093 (0.3%)9/1,093 (0.8%)39/1,093 (3.6%)
PBO - SCO Stratum1/1,103 (0.1%)2/1,103 (0.2%)35/1,103 (3.2%)
BEM - Combo Stratum0/37 (0%)0/37 (0%)6/37 (16.2%)
PBO - Combo Stratum0/36 (0%)0/36 (0%)9/36 (25%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventBEM - SCO StratumPBO - SCO StratumBEM - Combo StratumPBO - Combo Stratum
BradyarrhythmiaCardiac disorders1/10930/11030/370/36
Cardiac failureCardiac disorders1/10930/11030/370/36
Gastrointestinal haemorrhageGastrointestinal disorders1/10930/11030/370/36
VomitingGastrointestinal disorders1/10930/11030/370/36
COVID-19Infections and infestations1/10931/11030/370/36
Anaesthetic complicationInjury, poisoning and procedural complications1/10930/11030/370/36
HyponatraemiaMetabolism and nutrition disorders1/10930/11030/370/36
HypernatraemiaMetabolism and nutrition disorders1/10930/11030/370/36
Transient ischaemic attackNervous system disorders1/10930/11030/370/36
Renal impairmentRenal and urinary disorders1/10930/11030/370/36
Most frequent other events
Most frequent other events
EventBEM - SCO StratumPBO - SCO StratumBEM - Combo StratumPBO - Combo Stratum
DiarrhoeaGastrointestinal disorders24/109324/11034/373/36
DysguesiaNervous system disorders0/10930/11033/371/36
NauseaGastrointestinal disorders11/109310/11031/372/36
HypercholesterolaemiaMetabolism and nutrition disorders3/10934/11030/372/36
HyponatraemiaMetabolism and nutrition disorders2/10932/11030/372/36

Baseline characteristics

Modified intent-to-treat (mITT) population included subjects who received \>= 1 dose of study drug and had \>= 1 positive SARS-CoV-2 result through Day 5.

Age, Customized
Age, Customized(Participants)BEM - SCO StratumPBO - SCO StratumBEM - Combo StratumPBO - Combo StratumTotal
18-49 years28301261
50-64 years4294321313887
65-79 years48648718171008
>= 80 years798442169
Sex: Female, Male
Sex: Female, Male(Participants)BEM - SCO StratumPBO - SCO StratumBEM - Combo StratumPBO - Combo StratumTotal
Female61363418221287
Male4093991812838
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BEM - SCO StratumPBO - SCO StratumBEM - Combo StratumPBO - Combo StratumTotal
Hispanic or Latino86187516181770
Not Hispanic or Latino1231311916289
Unknown or Not Reported38271066
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BEM - SCO StratumPBO - SCO StratumBEM - Combo StratumPBO - Combo StratumTotal
American Indian or Alaska Native8111020
Asian685531127
Native Hawaiian or Other Pacific Islander00000
Black or African American737332151
White86788224281801
More than one race14005
Unknown or Not Reported585321
08

Study locations

264 sites
  • Atea Study Site
    Kingman, Arizona 86401, United States
  • Atea Study Site
    Prescott, Arizona 86301, United States
  • Atea Study Site
    Surprise, Arizona 85378, United States
  • Atea Study Site
    Tucson, Arizona 85741, United States
  • Atea Study Site
    Canoga Park, California 91303, United States
  • Atea Study Site
    Fullerton, California 92835, United States
  • Atea Study Site
    Inglewood, California 90301, United States
  • Atea Study Site
    La Palma, California 90623, United States
  • Atea Study Site
    Long Beach, California 90805, United States
  • Atea Study Site
    Long Beach, California 98015, United States
  • Atea Study Site
    Los Angeles, California 90017, United States
  • Atea Study Site
    Sacramento, California 95817, United States
  • Atea Study Site
    San Diego, California 92120, United States
  • Atea Study Site
    Coral Gables, Florida 33134, United States
  • Atea Study Site
    Cutler Bay, Florida 33189, United States
  • Atea Study Site
    Doral, Florida 33172, United States
  • Atea Study Site
    Hialeah, Florida 33010, United States
  • Atea Study Site
    Miami Gardens, Florida 33014, United States
  • Atea Study Site
    Miami, Florida 33125, United States
  • Atea Study Site
    Miami, Florida 33135, United States
  • Atea Study Site
    Miami, Florida 33155, United States
  • Atea Study Site
    Miami, Florida 33165, United States
  • Atea Study Site
    Miami, Florida 33173, United States
  • Atea Study Site
    Miami, Florida 33184, United States
  • Atea Study Site
    Miami, Florida 33186, United States
  • Atea Study Site
    North Miami Beach, Florida 33162, United States
  • Atea Study Site
    North Miami Beach, Florida 33179, United States
  • Atea Study Site
    Pembroke Pines, Florida 33024, United States
  • Atea Study Site
    Pompano Beach, Florida 33164, United States
  • Atea Study Site
    Tampa, Florida 33607, United States
  • Atea Study Site
    Tampa, Florida 33612, United States
  • Atea Study Site
    Tampa, Florida 33614, United States
  • Atea Study Site
    Tampa, Florida 33615, United States
  • Atea Study Site
    The Villages, Florida 32162, United States
  • Atea Study Site
    W. Miami, Florida 33144, United States
  • Atea Study Site
    West Palm Beach, Florida 33409, United States
  • Atea Study Site
    Eatonton, Georgia 31024, United States
  • Atea Study Site
    Orland Park, Illinois 60462, United States
  • Atea Study Site
    La Vista, Nebraska 68128, United States
  • Atea Study Site
    Bronx, New York 10456, United States
  • Atea Study Site
    Bronx, New York 10467, United States
  • Atea Study Site
    Chapel Hill, North Carolina 27514, United States
  • Atea Study Site
    High Point, North Carolina 27260, United States
  • Atea Study Site
    Chickasha, Oklahoma 73018, United States
  • Atea Study Site
    Providence, Rhode Island 02903, United States
  • Atea Study Site
    Greenville, South Carolina 29615, United States
  • Atea Study Site
    Rock Hill, South Carolina 29732, United States
  • Atea Study Site
    Carrollton, Texas 75006, United States
  • Atea Study Site
    Dallas, Texas 75230, United States
  • Atea Study Site
    DeSoto, Texas 75115, United States
  • Atea Study Site
    Forney, Texas 75126, United States
  • Atea Study Site
    Fort Worth, Texas 76164, United States
  • Atea Study Site
    Harlingen, Texas 78550, United States
  • Atea Study Site
    Houston, Texas 77065, United States
  • Atea Study Site
    Kingwood, Texas 77339, United States
  • Atea Study Site
    Lewisville, Texas 75057, United States
  • Atea Study Site
    Mesquite, Texas 75150, United States
  • Atea Study Site
    San Antonio, Texas 78215, United States
  • Atea Study Site
    Splendora, Texas 77372, United States
  • Atea Study Site
    Stafford, Texas 77477, United States
  • Atea Study Site
    Sugar Land, Texas 77479, United States
  • Atea Study Site
    Bahía Blanca, Buenos Aires B800FTD, Argentina
  • Atea Study Site
    Ciudad Autonoma de Buenos Aire, Buenos Aires C1056ABJ, Argentina
  • Atea Study Site
    Mar Del Plata, Buenos Aires B7600FYK, Argentina
  • Atea Study Site
    Mar Del Plata, Buenos Aires B7602DCK, Argentina
  • Atea Study Site
    Ramos Mejía, Buenos Aires 1704, Argentina
  • Atea Study Site
    San Nicolas, Buenos Aires B2900DMH, Argentina
  • Atea Study Site
    Buenos Aires, Ciudad Autonoma Buenos Aires C1180AAX, Argentina
  • Atea Study Site
    Córdoba, Cordoba 5000, Argentina
  • Atea Study Site
    Rosario, Santa Fe 2000, Argentina
  • Atea Study Site
    Rosario, Santa Fe S2000PBJ, Argentina
  • Atea Study Site
    San Miguel De Tucumán, Tucuman 4000, Argentina
  • Atea Study Site
    San Miguel De Tucumán, Tucuman T4000AXL, Argentina
  • Atea Study Site
    Ciudad Autonoma de Buenos Aire, C1202ABB, Argentina
  • Atea Study Site
    Córdoba, CPX5000EPU, Argentina
  • Atea Study Site
    Santiago Del Estero, 4200, Argentina
  • Atea Study Site
    Maceió, Alagoas 57052-580, Brazil
  • Atea Study Site
    Salvador, Bahia 40050-410, Brazil
  • Atea Study Site
    Salvador, Bahia 40150, Brazil
  • Atea Study Site
    Fortaleza, Ceara 60160-070, Brazil
  • Atea Study Site
    Fortaleza, Ceara 60430-370, Brazil
  • Atea Study Site
    Brasília, Distrito Federal 70710-100, Brazil
  • Atea Study Site
    Cachoeiro De Itapemirim, Espirito Santo 2938-020, Brazil
  • Atea Study Site
    Serra, Espirito Santo 29101-850, Brazil
  • Atea Study Site
    Vitória, Espirito Santo 29043-260, Brazil
  • Atea Study Site
    Cuiabá, Mato Grosso 78048, Brazil
  • Atea Study Site
    Belo Horizonte, Minas Gerais 30110-934, Brazil
  • Atea Study Site
    Belo Horizonte, Minas Gerais 30150-221, Brazil
  • Atea Study Site
    Belo Horizonte, Minas Gerais 30220-330, Brazil
  • Atea Study Site
    Campina Grande Do Sul, Parana 83430-000, Brazil
  • Atea Study Site
    Rio De Janeiro, Rio Do Janeiro 20241-180, Brazil
  • Atea Study Site
    Natal, Rio Grande Do Norte 59020-500, Brazil
  • Atea Study Site
    Natal, Rio Grande Do Norte 59025, Brazil
  • Atea Study Site
    Passo Fundo, Rio Grande Do Sul 99010-260, Brazil
  • Atea Study Site
    Porto Alegre, Rio Grande Do Sul 90020-090, Brazil
  • Atea Study Site
    Porto Alegre, Rio Grande Do Sul 90035-004, Brazil
  • Atea Study Site
    Porto Alegre, Rio Grande Do Sul 90035-903, Brazil
  • Atea Study Site
    Porto Alegre, Rio Grande Do Sul 90610-000, Brazil
  • Atea Study Site
    Porto Velho, Rondonia 78918-791, Brazil
  • Atea Study Site
    Blumenau, Santa Catarina 89020-430, Brazil

Showing the first 100 of 264 sites across 19 countries.

09

References and documents

Study documents

  • Study protocol · Jun 15, 2023
  • Statistical analysis plan · Jun 24, 2024

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05629962
Lead sponsor
Atea Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Nov 29, 2022
Start date
Nov 25, 2022
Primary completion
Apr 25, 2024
Completion
May 30, 2024
Results posted
Jun 13, 2025
Last update
Jun 13, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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