> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/sunrise-3-efficacy-and-safety-of-bemnifosbuvir-in-high-risk-bb1d25f8-4c33-46b4-99b6-25db929367b0 > Record changed: 2026-10-13 # SUNRISE-3: Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19 NCT05629962 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) Participants 2,285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) Lead sponsor Atea Pharmaceuticals, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) Start date 2022-11-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) Number of sites 263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Short title** SUNRISE-3: Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) ## Dates **Completion date** 2024-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **First posted** 2022-11-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Registry last updated** 2025-06-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Primary completion date** 2024-04-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Start date** 2022-11-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) ## Size and sites **Actual participants** 2,285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Participants** 2,285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Number of sites** 263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Lead sponsor** Atea Pharmaceuticals, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) ## Identifiers **Registry ID** NCT05629962 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **ClinicalTrials.gov ID** NCT05629962 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) ## Outcomes ### Primary outcomes 1. Percentage of Subjects Hospitalized for Any Cause or Died Due to Any Cause Timeframe: Day 1 through Day 29 ### Secondary outcomes 1. Percentage of Subjects Hospitalized Due to COVID-19 or Died Due to Any Cause Timeframe: Day 1 through Day 29 2. Percentage of Subjects Who Died Due to Any Cause Timeframe: Day 1 through Day 29; Day 1 through Day 60 3. Percentage of Subjects With COVID-19-related Complications Timeframe: 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 Timeframe: Day 1 through Day 29; Day 1 through Day 60 5. Percentage of Subjects With COVID-19 Symptom Relapse Timeframe: Day 1 through Day 29 6. Percentage of Subjects With Viral Load Rebound Timeframe: Day 1 through Day 29 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) ## Sites - Atea Study SiteKingman, United States - Atea Study SitePrescott, United States - Atea Study SiteSurprise, United States - Atea Study SiteTucson, United States - Atea Study SiteCanoga Park, United States - Atea Study SiteFullerton, United States - Atea Study SiteInglewood, United States - Atea Study SiteLa Palma, United States - Atea Study SiteLong Beach, United States - Atea Study SiteLong Beach, United States - Atea Study SiteLos Angeles, United States - Atea Study SiteSacramento, United States - Atea Study SiteSan Diego, United States - Atea Study SiteCoral Gables, United States - Atea Study SiteCutler Bay, United States - Atea Study SiteDoral, United States - Atea Study SiteHialeah, United States - Atea Study SiteMiami, United States - Atea Study SiteMiami, United States - Atea Study SiteMiami, United States - Atea Study SiteMiami, United States - Atea Study SiteMiami, United States - Atea Study SiteMiami, United States - Atea Study SiteMiami, United States - Atea Study SiteMiami Gardens, United States And 238 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05629962) ## Related records ### Drugs (1) - [Bemnifosbuvir](https://trialight.com/data/asset/bemnifosbuvir-2801e1d5-93ea-48b5-a5b6-91d5bb0db82e.md) ### Lead sponsors (1) - [Atea Pharmaceuticals, Inc.](https://trialight.com/data/company/atea-pharmaceuticals-inc-527d0102-265b-441c-8970-d0294f7ee688.md) ### Conditions (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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