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Impact of Molnupiravir Treatment on Patient-Reported Coronavirus Disease 2019 (COVID-19) Symptoms in the Phase 3 MOVe-OUT Trial: A Randomized, Placebo-Controlled Trial

Guan et al., Clinical Infectious Diseases, doi:10.1093/cid/ciad409, MOVe-OUT, NCT04575597
Jul 2023  
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Symptom recovery details for the MOVe-OUT trial. Results are shown with the main paper Jayk Bernal.
Concerns have been raised that the mutagenic mechanism of action may create dangerous variants or cause cancer Hadj Hassine, Huntsman, Marikawa, Swanstrom, Waters, Zibat. Multiple analyses have identifed variants potentially created by molnupiravir Fountain-Jones, Sanderson,
Guan et al., 19 Jul 2023, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, 18 authors, study period May 2021 - November 2021, average treatment delay 4.0 days, trial NCT04575597 (history) (MOVe-OUT).
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Impact of Molnupiravir Treatment on Patient-Reported Coronavirus Disease 2019 (COVID-19) Symptoms in the Phase 3 MOVe-OUT Trial: A Randomized, Placebo-Controlled Trial
Merck Yanfen Guan, Amy Puenpatom, Matthew G Johnson, Ying Zhang, Yujie Zhao, Joseph Surber, Aaron Weinberg, Carlos Brotons, Roman Kozlov, Rudy Lopez, Kathleen Coetzee, Joel Santiaguel, Jiejun Du, Angela Williams-Diaz, Michelle Brown, Amanda Paschke, Carisa De Anda, Josephine M Norquist
Clinical Infectious Diseases, doi:10.1093/cid/ciad409
Background. Molnupiravir is an orally administered antiviral authorized for COVID-19 treatment in adults at high risk of progression to severe disease. Here, we report secondary and post hoc analyses of participants' self-reported symptoms in the MOVe-OUT trial, which evaluated molnupiravir initiated within 5 days of symptom onset in nonhospitalized, unvaccinated adults with mild-to-moderate, laboratory-confirmed COVID-19. Methods. Eligible participants completed a 15-item symptom diary daily from day 1 (randomization) through day 29, rating symptom severity as "none," "mild," "moderate," or "severe"; loss of smell and loss of taste were rated as "yes" or "no." Time to sustained symptom resolution/improvement was defined as the number of days from randomization to the first of 3 consecutive days of reduced severity, without subsequent relapse. Time to symptom progression was defined as the number of days from randomization to the first of 2 consecutive days of worsening severity. The Kaplan-Meier method was used to estimate event rates at various time points. The Cox proportional hazards model was used to estimate the hazard ratio between molnupiravir and placebo. Results. For most targeted COVID-19 symptoms, sustained resolution/improvement was more likely, and progression was less likely, in the molnupiravir versus placebo group through day 29. When evaluating 5 distinctive symptoms of COVID-19, molnupiravir participants had a shorter median time to first resolution (18 vs 20 d) and first alleviation (13 vs 15 d) of symptoms compared with placebo. Conclusions. Molnupiravir treatment in at-risk, unvaccinated patients resulted in improved clinical outcomes for most participant-reported COVID-19 symptoms compared with placebo. Clinical Trials Registration. NCT04575597.
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