Design

• Non-hospitalized adults with mild or moderate COVID-19. 

o    Laboratory confirmed SARS-CoV-2 infection ≤5 days before randomization.

o    The onset of COVID-19 signs ≤5 days before randomization. 

• Patient population 

o    All at increased risk for severe illness from COVID-19

o    >60 years of age, active cancer, CKD, COPD, obesity (BMI≥30), serious heart conditions (CAD, heart failure, cardiomyopathies), DM

o    Unvaccinated against SARS-CoV-2

o    N=1550

• Stratification

o    Time from symptom onset to randomization (≤3 days, >3 [4-5] days

• Dose

o    Molnupiravir 800 mg every 12 hours for 5 days vs placebo, randomized 1:1

• Efficacy endpoints

o    Primary: All-cause hospitalization≥24 hours) or death through day 29.

o    Secondary: Improvement/progression of patient-reported signs/symptoms of COVID-19 through day 29 WHO 11-point ordinal scale measuring COVID-19 severity at pre-specified timepoints.

Results

• Molnupiravir reduces the risk of hospitalization or death through day 29
• For all key subgroups, a lower proportion of participants in the molnupiravir group were hospitalized or died. 
• The adverse events associated with the use of molnupiravir were diarrhea, nausea, pneumonia, and raised ALT. 
• The incidence of drug-related adverse events in the molnupiravir group was low and similar across groups. 

Conclusion

• Molnupiravir 800 mg Q12H for 5 days is generally well tolerated.
• Early treatment with molnupiravir reduced the risk of hospitalization or death in at-risk, unvaccinated adults with COVID-19. 
• No evidence of hematologic toxicity for molnupiravir in clinical studies. 
• No safety concerns have been identified throughout the clinical development program. 

Reference: Bernal AJ, Gomes da Silva MM, Musungaie DB, et al. Molnupiravir for oral treatment of COVID-19 in nonhospitalized patients. N Engl J med. 2022; 386: 509-520.