At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19
In Brief
A Phase 3 clinical trial evaluating Bemnifosbuvir (BEM) and Placebo for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2 Infection) and COVID-19. Completed, enrolled 2,285 participants across 263 sites in 19 countries.
Detailed 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.
Study Details
Timeline
Interventions
BEM tablets administered orally every 12 hours (twice a day) for a total of 5 days
Placebo tablets administered orally every 12 hours (twice a day) for a total of 5 days