Evidence map›Paper›PMID 37466374›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

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

Yanfen Guan, Amy Puenpatom, Matthew G Johnson, Ying Zhang, Yujie Zhao, Joseph Surber, Aaron Weinberg, Carlos Brotons, Roman Kozlov, Rudy Lopez and 8 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04575597 (A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults With COVID-19.), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04575597 phase2 / phase3completednot on this map

A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults With COVID-19.

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2020 to 2022Enrolled1,735ConditionsCoronavirus Disease (COVID-19)ArmsMolnupiravir, Placebo
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Trial
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  10. Antivirals in COVID-19: A Focus on Pediatric Cardiac Patients.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2025
    Review
  11. Article
  12. Review: The Landscape of Antiviral Therapy for COVID-19 in the Era of Widespread Population Immunity and Omicron-Lineage Viruses.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Yanfen GuanMerck & Co, Inc, Rahway, New Jersey, USA.
Amy PuenpatomMerck & Co, Inc, Rahway, New Jersey, USA.
Matthew G JohnsonMerck & Co, Inc, Rahway, New Jersey, USA.
Ying ZhangMerck & Co, Inc, Rahway, New Jersey, USA.
Yujie ZhaoMerck & Co, Inc, Rahway, New Jersey, USA.
Joseph SurberCentricity Research, Columbus, Georgia, USA.
Aaron WeinbergCarbon Health Technologies, Inc, North Hollywood, California, USA.
Carlos BrotonsEAP Sardenya, Biomedical Research Institute Sant Pau, Barcelona, Spain.
Roman KozlovSmolensk State Medical University, Smolensk, Russia.
Rudy LopezClínica Médica Especialista en Pediatría e Infectología Pediátrica, Guatemala City, Guatemala.
Kathleen CoetzeePaarl Research Centre, Paarl, South Africa.
Joel SantiaguelPhilippine General Hospital, University of the Philippines Manila, Manila, Philippines.
Jiejun DuMerck & Co, Inc, Rahway, New Jersey, USA.
Angela Williams-DiazMerck & Co, Inc, Rahway, New Jersey, USA.
Michelle BrownMerck & Co, Inc, Rahway, New Jersey, USA.
Amanda PaschkeMerck & Co, Inc, Rahway, New Jersey, USA.
Carisa De AndaMerck & Co, Inc, Rahway, New Jersey, USA.
Josephine M NorquistMerck & Co, Inc, Rahway, New Jersey, USA.

Funding

Merck, Sharp & Dohme LLC
6 · The paper itself

Abstract

backgroundMolnupiravir 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.

methodsEligible 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.

resultsFor 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.

conclusionsMolnupiravir 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.

Indexed as

COVID-19AdultCOVID-19 Drug TreatmentCytidineHumansHydroxylaminesPatient Reported Outcome MeasuresSARS-CoV-2Treatment OutcomeCytidineHydroxylaminesmolnupiravirantiviralclinical trialpublic healthSARS-CoV-2β-D-N4-hydroxycytidine

Identifiers

PMID37466374
PMCPMC10686947

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.