Evidence map›Paper›PMID 34941423›Full record

Trial reportScience translational medicine2022

A phase 2a clinical trial of molnupiravir in patients with COVID-19 shows accelerated SARS-CoV-2 RNA clearance and elimination of infectious virus.

William A Fischer, Joseph J Eron, Wayne Holman, Myron S Cohen, Lei Fang, Laura J Szewczyk, Timothy P Sheahan, Ralph Baric, Katie R Mollan, Cameron R Wolfe and 9 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Science translational medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 201 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
201citing papers in PubMed, 15 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

201 citing papers in PubMed, 15 syntheses or guidelines pooled it.

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  6. Molnupiravir for treatment of adults with mild or moderate COVID-19: a systematic review and meta-analysis of randomized controlled trials.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2023
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141 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

William A FischerInstitute for Global Health and Infectious Diseases, Division of Pulmonary Diseases and Critical Care Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0002-4900-098X
Joseph J EronDepartment of Medicine, Division of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0002-4938-0644
Wayne HolmanRidgeback Biotherapeutics LP, Miami, FL, USA.ORCID 0000-0003-2163-3707
Myron S CohenDepartment of Medicine, Division of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0001-5917-9664
Lei FangPharstat Inc., Raleigh, NC, USA.ORCID 0000-0002-2647-914X
Laura J SzewczykRidgeback Biotherapeutics LP, Miami, FL, USA.ORCID 0000-0003-0311-0654
Timothy P SheahanDepartment of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0001-9181-2183
Ralph BaricDepartment of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0001-6827-8701
Katie R MollanGillings School of Global Public Health, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Cameron R WolfeDepartment of Medicine, Division of Infectious Diseases, Duke University Medical Center, Durham, NC, USA.ORCID 0000-0002-5365-5030
Elizabeth R DukeFred Hutchinson Cancer Research Center, University of Washington, Seattle, WA, USA.ORCID 0000-0002-3348-9039
Masoud M AzizadValley Clinical Trials Inc., Northridge, CA, USA.
Katyna Borroto-EsodaKBE Consulting, Raleigh, NC, USA.ORCID 0000-0002-3909-6578
David A WohlDepartment of Medicine, Division of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0002-7764-0212
Robert W CoombsDepartment of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, USA.ORCID 0000-0003-2709-0512
Amy James LoftisInstitute for Global Health and Infectious Diseases, Division of Pulmonary Diseases and Critical Care Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Paul AlabanzaLineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Felicia LipanskyRidgeback Biotherapeutics LP, Miami, FL, USA.ORCID 0000-0002-3351-6017
Wendy P PainterRidgeback Biotherapeutics LP, Miami, FL, USA.ORCID 0000-0001-6710-1277

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
NCATS NIH HHS UL1 TR002489NIAID NIH HHS P30 AI050410
6 · The paper itself

Abstract

There is an urgent need for an effective, oral, direct-acting therapeutic to block transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and prevent progression to severe coronavirus disease 2019 (COVID-19). In a phase 2a double-blind, placebo-controlled, randomized, multicenter clinical trial, we evaluated the safety, tolerability, and antiviral efficacy of the nucleoside analog molnupiravir in 202 unvaccinated participants with confirmed SARS-CoV-2 infection and symptom duration <7 days. Participants were randomized 1:1 to receive molnupiravir (200 mg) or placebo and then 3:1 to receive molnupiravir (400 or 800 mg) or placebo, orally twice daily for 5 days. Antiviral activity was assessed by reverse transcriptase polymerase chain reaction (RT-PCR) for SARS-CoV-2 RNA in nasopharyngeal swabs. Infectious virus was assessed by inoculation of cultured Vero cells with samples from nasopharyngeal swabs and was detected by RT-PCR. Time to viral RNA clearance (primary endpoint) was decreased in the 800-mg molnupiravir group (median 14 days) compared to the placebo group (median 15 days) (log rank

Indexed as

COVID-19AnimalsChlorocebus aethiopsCytidineHumansHydroxylaminesRNA, ViralSARS-CoV-2Treatment OutcomeVero CellsCytidineHydroxylaminesmolnupiravirRNA, Viral

Identifiers

PMID34941423
PMCPMC10763622

What OpenQuestion holds

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Registered trials

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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.