Impact of Molnupiravir Treatment on Patient-Reported COVID-19 Symptoms in the Phase 3 MOVe-OUT Trial : A Randomized, Placebo-Controlled Trial
Guan, Yanfen (Merck & Co Inc (New Jersey, Estats Units d'Amèrica))
Puenpatom, Amy (Merck & Co Inc (New Jersey, Estats Units d'Amèrica))
Johnson, Matthew G. (Merck & Co Inc (New Jersey, Estats Units d'Amèrica))
Zhang, Ying (Merck & Co Inc (New Jersey, Estats Units d'Amèrica))
Zhao, Yujie (Merck & Co Inc (New Jersey, Estats Units d'Amèrica))
Surber, Joseph (Centricity Research (Georgia, Estats Units d'Amèrica))
Weinberg, Aaron (Carbon Health Technologies Inc ( California, Estats Units d'Amèrica))
Brotons, Carlos (Institut d'Investigació Biomèdica Sant Pau)
Kozlov, Roman (Smolensk State Medical University (Rússia))
Lopez, Rudy (Clínica Médica Especialista en Pediatría e Infectología Pediátrica (Guatemala))
Coetzee, Kathleen (Paarl Research Centre (Sud Àfrica))
Santiaguel, Joel (University of the Philippines Manila (Filipines))
Du, Jiejun (Merck & Co Inc (New Jersey, Estats Units d'Amèrica))
Williams-Diaz, Angela (Merck & Co Inc (New Jersey, Estats Units d'Amèrica))
Brown, Michelle (Merck & Co Inc (New Jersey, Estats Units d'Amèrica))
Paschke, Amanda (Merck & Co Inc (New Jersey, Estats Units d'Amèrica))
De Anda, Carisa (Merck & Co Inc (New Jersey, Estats Units d'Amèrica))
Norquist, Josephine M. (Merck & Co Inc (New Jersey, Estats Units d'Amèrica))
Universitat Autònoma de Barcelona

Data:	2023
Resum:	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. 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. 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. 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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	SARS-CoV-2 ; Antiviral ; Clinical trial ; Public health ; β-D-N4-hydroxycytidine
Publicat a:	Clinical infectious diseases (University of Chicago. Press), Vol. 77 Núm. 11 (january 2023) , p. 1521-1530, ISSN 1537-6591

DOI: 10.1093/cid/ciad409
PMID: 37466374

10 p, 806.5 KB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut de Recerca Sant Pau
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