Details

Autor(en) / Beteiligte

• Guan, Yanfen
• Puenpatom, Amy
• Johnson, Matthew G
• Zhang, Ying
• Zhao, Yujie
• Surber, Joseph
• Weinberg, Aaron
• Brotons, Carlos
• Kozlov, Roman
• Lopez, Rudy
• Coetzee, Kathleen
• Santiaguel, Joel
• Du, Jiejun
• Williams-Diaz, Angela
• Brown, Michelle
• Paschke, Amanda
• De Anda, Carisa
• Norquist, Josephine M

Titel

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

Ist Teil von

• Clinical infectious diseases, 2023-11, Vol.77 (11), p.1521-1530

Ort / Verlag

US: Oxford University Press

Erscheinungsjahr

2023

Link zum Volltext

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• Abstract 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. Secondary and post hoc analyses of patient-reported outcome data from the phase 3 component of MOVe-OUT demonstrated improved clinical outcomes with molnupiravir treatment—both for sustained resolution/improvement and progression—for most targeted COVID-19 symptoms compared with placebo. Graphical abstract Graphical Abstract