Trials / Completed
CompletedNCT05629962
SUNRISE-3: Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,285 (actual)
- Sponsor
- Atea Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bemnifosbuvir (BEM) | BEM tablets administered orally every 12 hours (twice a day) for a total of 5 days |
| DRUG | Placebo | Placebo tablets administered orally every 12 hours (twice a day) for a total of 5 days |
Timeline
- Start date
- 2022-11-25
- Primary completion
- 2024-04-25
- Completion
- 2024-05-30
- First posted
- 2022-11-29
- Last updated
- 2025-06-13
- Results posted
- 2025-06-13
Locations
263 sites across 19 countries: United States, Argentina, Brazil, Canada, Germany, India, Japan, Latvia, Mexico, Netherlands, Pakistan, Philippines, Romania, South Africa, Spain, Sweden, Tunisia, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05629962. Inclusion in this directory is not an endorsement.