Final analysis from the phase 3 MOVe-OUT trial showed that treatment with the investigational oral antiviral molnupiravir reduced the risk of hospitalization or death by 30% in at-risk patients with mild to moderate COVID-19.
Molnupiravir is an orally administered form of a ribonucleoside analogue that inhibits the replication of SARS-CoV-2. The updated trial analysis (ClinicalTrials.gov Identifier: NCT04575597) included 1433 adults with mild to moderate COVID-19 with symptom onset within 5 days of randomization. Patients were required to have at least 1 risk factor associated with poor disease outcomes.
Results showed that 6.8% (n=48/709) of patients treated with molnupiravir were either hospitalized or died through day 29 following randomization compared with 9.7% (n=68/699) of patients treated with placebo (absolute risk reduction, 3.0%; 95% CI, 0.1-5.9; nominal P =.0218), corresponding to a relative risk reduction of 30% (relative risk, 0.70; 95% CI, 0.49-0.99). There was 1 death reported in the molnupiravir arm and 9 deaths in the placebo arm.
The safety profile of molnupiravir was consistent with that previously reported at the planned interim analysis.
Merck and Ridgeback Biotherapeutics submitted a request for Emergency Use Authorization for molnupiravir in October 2021 based on efficacy results from the planned interim analysis of the MOVe-OUT trial. Findings of this interim analysis, which included data from 775 adults, showed that molnupiravir reduced the risk of hospitalization or death by approximately 50%.
The Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee will be reviewing all available data for molnupiravir on November 30, 2021.
Merck and Ridgeback Biotherapeutics provide update on results from MOVe-OUT study of molnupiravir, an investigational oral antiviral medicine, in at risk adults with mild-to-moderate COVID-19. News release. Merck and Ridgeback Biotherapeutics. Accessed November 29, 2021. https://www.businesswire.com/news/home/20211126005279/en/Merck-and-Ridgeback-Biotherapeutics-Provide-Update-on-Results-from-MOVe-OUT-Study-of-Molnupiravir-an-Investigational-Oral-Antiviral-Medicine-in-At-Risk-Adults-With-Mild-to-Moderate-COVID-19.