Molnupiravir (Lagevrio)
800 mg of Molnupiravir orally twice daily for 5 days.
Placebo
Placebo orally twice daily for 5 days.
COVID 19 outpatients
Patients with laboratory-confirmed mild-to-moderate COVID-19, with symptom onset within 5 days of study randomization. Eligible subjects were 18 years of age and older and had one or more pre-defined risk factors for disease progression: 60 years of age or older, diabetes, obesity (BMI >30), chronic kidney disease, serious heart conditions, chronic obstructive pulmonary disease, or active cancer. The study included symptomatic subjects not vaccinated against SARS-CoV-2 and who had laboratory confirmed SARS-CoV-2 infection and symptom onset within 5 days of enrolment.
Double-blind.
170 sites in 23 countries: Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany...
Planned interim analysis to assess efficacy/futility based on 50% of the planned phase 3 enrollment (775/1550) with an alpha spending function that controlled the type I error rate at alpha = 0.025 (one sided) with a criterion to declare early efficacy of p<0.0092. Missing mortality status at day 29 was imputed as hospitalization or death.
Trial stopped early for efficacy at the planned interim analysis. The formal evaluation of efficacy is considered complete at the planned interim analysis at which time the statistical criterion for success was met. The analyses of data for the full population are considered supportive analyses.
Fischer (all doses), 2021 NCT04405570
molnupiravir (n=140) vs. placebo (n=62)
randomized controlled trial
some concerns about risk of bias
Molnupiravir
Molnupiravir 200mg, 400mg or 800mg administered orally twice daily for 5 days.