A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the 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
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.
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:
Use of adequate contraception for females of childbearing potential
Exclusion Criteria:
Ciudad Autonoma de Buenos Aire, Buenos Aires C1056ABJ, Argentina
Ciudad Autonoma de Buenos Aire, C1202ABB, Argentina
Bento Gonçalves, São Paulo 95700-084, Brazil
Ijuí, São Paulo 98700-000, Brazil
Hyderabad, Andhra Pradesh 500018, India