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

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.

Timeline

Start

2022-11-25

Primary completion

2024-04-25

Completion

2024-05-30

Outcome

Missed primary endpoint

registry analysis (superiority test); BEM - SCO Stratum vs PBO - SCO Stratum; p = 0.954; Cochran-Mantel-Haenszel NCT05629962 ↗

Drugs

Indications