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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 paper1.
Potential risks include the creation of dangerous variants, and mutagenicity, carcinogenicity, teratogenicity, and embryotoxicity2-11. Multiple analyses have identified variants potentially created by molnupiravir12-15.
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). Contact: yanfen_guan@merck.com.
This PaperMolnupiravirAll
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. ClinicalTrials.gov: NCT04575597.
References
Abdelnabi, Foo, Jonghe, Maes, Weynand et al., Molnupiravir inhibits replication of the emerging SARS-CoV-2 variants of concern in a hamster infection model, J Infect Dis
Adjei, Hong, Molinari, Mortality risk among patients hospitalized primarily for COVID-19 during the omicron and Delta variant pandemic periods -United States, MMWR Morb Mortal Wkly Rep
Amdal, Taylor, Kuliś, Health-related quality of life in patients with COVID-19; international development of a patient-reported outcome measure, J Patient Rep Outcomes
Bernal, Da Silva, Musungaie, Molnupiravir for oral treatment of COVID-19 in nonhospitalized patients, N Engl J Med
Butler, Hobbs, Gbinigie, Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial, Lancet
Caraco, Crofoot, Moncada, Phase 2/3 trial of molnupiravir for treatment of COVID-19 in nonhospitalized adults, NEJM Evidence
Danza, Koo, Haddix, SARS-CoV-2 infection and hospitalization among adults aged ≥18 years, by vaccination status, before and during SARS-CoV-2 B. 1.1. 529 (omicron) variant predominance, MMWR Morb Mortal Wkly Rep
Jassat, Karim, Mudara, Clinical severity of COVID-19 in patients admitted to hospital during the omicron wave in South Africa: a retrospective observational study, Lancet Glob Health
Johnson, Puenpatom, Moncada, Effect of molnupiravir on biomarkers, respiratory interventions, and medical services in COVID-19: a randomized, placebo-controlled trial, Ann Intern Med
Kluzek, Dean, Wartolowska, Patient-reported outcome measures (PROMs) as proof of treatment efficacy, BMJ Evid Based Med
Madhi, Kwatra, Myers, Population immunity and COVID-19 severity with omicron variant in South Africa, N Engl J Med
Mercieca-Bebber, King, Calvert, Stockler, Friedlander, The importance of patient-reported outcomes in clinical trials and strategies for future optimization, Patient Relat Outcome Meas
Pourkarim, Pourtaghi-Anvarian, Rezaee, Molnupiravir: a new candidate for COVID-19 treatment, Pharmacol Res Perspect
Romano, Fehnel, Stoddard, Development of a novel patient-reported outcome measure to assess signs and symptoms of COVID-19, J Patient Rep Outcomes
Sheahan, Sims, Zhou, An orally bioavailable broad-spectrum antiviral inhibits SARS-CoV-2 in human airway epithelial cell cultures and multiple coronaviruses in mice, Sci Transl Med
Takashita, Kinoshita, Yamayoshi, Efficacy of antiviral agents against the SARS-CoV-2 omicron subvariant BA.2, N Engl J Med
Takashita, Yamayoshi, Simon, Efficacy of antibodies and antiviral drugs against omicron BA.2.12.1, BA.4, and BA.5 subvariants, N Engl J Med
Wahl, Gralinski, Johnson, SARS-CoV-2 infection is effectively treated and prevented by EIDD-2801, Nature
Watson, Barnsley, Toor, Hogan, Winskill et al., Global impact of the first year of COVID-19 vaccination: a mathematical modelling study, Lancet Infect Dis
Wong, Shah, Johnston, Carlsten, Ryerson, Patient-reported outcome measures after COVID-19: a prospective cohort study, Eur Respir J
Yoon, Toots, Lee, Orally efficacious broad-spectrum ribonucleoside analog inhibitor of influenza and respiratory syncytial viruses, Antimicrob Agents Chemother
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