6/28/23, 11:19 PM MOVe-OUT Pathway Feedback Search Clinical Topics Home Studies MOVe-OUT MOVe-OUT Disease COVID 19 infection Trial question What is the role of early treatment with molnupiravir in unvaccinated adults with COVID-19? Study design Multi-center Double blinded RCT Population Characteristics of study participants 51.0% female N = 1408 49.0% male 1408 patients (723 female, 685 male) Inclusion criteria: nonhospitalized, unvaccinated adults with mild-to-moderate, laboratory- confirmed COVID-19 and at least one risk factor for severe COVID-19 illness Key exclusion criteria: anticipated need for hospitalization for COVID-19 within 48 hours, dialysis, pregnancy, severe neutropenia, platelet count < 100,000/mL Interventions N=709 molnupiravir (800 mg administered PO BID for 5 days) N=699 placebo (matching placebo administered PO BID for 5 days) Primary outcome Hospitalization or death at day 29 https://web.pathway.md/studies/recfO864QbVD5msRp 1/2 6/28/23, 11:19 PM MOVe-OUT Pathway 9.7 % 9.7 7.3 % 6.8 4.8 % Significant decrease 2.4 % NNT = 34 0.0 % Molnupiravir Placebo Significant decrease in hospitalization or death at day 29 (6.8% vs. 9.7%; ARD -3, 95% CI -5.9 to -0.1) Secondary outcomes Significant decrease in hospitalization or death at day 29, interim analysis (7.3% vs. 14.1%; ARD -6.8, 95% CI -11.3 to -2.4) Borderline significant decrease in death from all causes at day 29 (0.1% vs. 1.3%; RR 0.11, 95% CI 0.01 to 0.86) Borderline significant decrease in COVID-19 related hospitalization or death at day 29 (6.3% vs. 9.2%; ARD -2.8, 95% CI -5.7 to 0) Safety outcomes No significant difference in adverse events. Conclusion In nonhospitalized, unvaccinated adults with mild-to-moderate, laboratory-confirmed COVID-19 and at least one risk factor for severe COVID-19 illness, molnupiravir was superior to placebo with respect to hospitalization or death at day 29. Reference Ang lica Jayk Bernal, Monica M Gomes da Silva, Dany B Musungaie et al. Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients. N Engl J Med. 2022 Feb 10;386(6):509-520. Open reference URL https://web.pathway.md/studies/recfO864QbVD5msRp 2/2