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Molnupiravir for COVID-19
24 studies from 459 scientists
67,587 patients in 8 countries
Statistically significant improvement for ventilation, progression, recovery, and viral clearance.
13 studies from 11 teams in 7 countries show statistically significant improvements.
Potential risks include the creation of dangerous variants, carcinogenicity, and genotoxicity.
COVID-19 Molnupiravir studies. Dec 2022. c19early.org/m
0 0.5 1 1.5+ All studies 21% With exclusions 23% Mortality 28% Hospitalization 7% Recovery 19% Viral clearance 34% RCTs 42% RCT mortality 52% Early 26% Late -8% Favorsmolnupiravir Favorscontrol
Molnupiravir COVID-19 studies. Potential risks of the mechanism of action include the creation of dangerous variants, and mutagenicity, carcinogenicity, teratogenicity, and embryotoxicity [Hadj Hassine, Swanstrom, Waters]. There is substantial publication bias. Two trials (CTRI/2021/05/033864 and CTRI/2021/08/0354242) reported no significant efficacy, however the results have not been published. Multiple trials have not reported results and did not respond to requests [Lawrence]. Recent:
Zheng
Sinha
Liu
Wong
Miranda
Suzuki
Alteri.
Molnupiravir has been officially adopted for early treatment in 12 countries. Submit updates/corrections.
Nov 16
Zheng et al., BMJ, doi:10.1136/bmj-2022-071932 Comparative effectiveness of sotrovimab and molnupiravir for prevention of severe covid-19 outcomes in patients in the community: observational cohort study with the OpenSAFELY platform
100% higher combined mortality/hospitalization [p=0.005]. Retrospective 3,331 sotrovimab and 2,689 molnupiravir patients in the UK, showing higher risk of combined hospitalization/death with molnupiravir.
Nov 14
Sinha et al., Cureus, doi:10.7759/cureus.31508 Efficacy and Safety of Molnupiravir in Mild COVID-19 Patients in India
65% lower hospitalization [p=0.005], 53% better improvement [p=0.01], and 48% improved viral clearance [p<0.0001]. RCT 1,218 outpatients in India, showing lower hospitalization, better clinical improvement, and improved viral clearance with molnupiravir.
Oct 30
Liu et al., Infectious Diseases and Therapy, doi:10.1007/s40121-022-00716-7 Disease Progression of Hospitalized Elderly Patients with Omicron BA.2 Treated with Molnupiravir
18% shorter hospitalization [p=0.14] and 21% faster viral clearance [p=0.1]. Retrospective 42 elderly patients in China showing faster viral clearance with molnupiravir.
Oct 8
Wong et al., The Lancet, doi:10.1016/S0140-6736(22)01586-0 Real-world effectiveness of molnupiravir and nirmatrelvir plus ritonavir against mortality, hospitalisation, and in-hospital outcomes among community-dwelling, ambulatory patients with confirmed SARS-CoV-2 infection during the omicron wave in Hong Kong: an observational study
24% lower mortality [p=0.01], 60% lower ventilation [p=0.02], 26% lower ICU admission [p=0.24], and 2% lower hospitalization [p=0.58]. PSM retrospective 1,074,856 outpatients in Hong Kong, showing lower mortality with molnupiravir.
Oct 6
Butler et al., SSRN (Preprint) Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): preliminary analysis from the United Kingdom randomised, controlled open-label, platform adaptive trial
60% lower mortality [p=0.29], 6% higher combined mortality/hospitalization [p=0.34], 9% higher hospitalization [p=0.57], and 3% lower transmission [p=0.9]. 25,000 patient RCT in the UK, showing faster recovery but no significant difference in hospitalization/death or transmission. Improved recovery may in part be due to placebo effect in this open label trial with self-reported symptomatic d..
Oct 6
Alteri et al., Research Square, doi:10.21203/rs.3.rs-2105569/v1 (Preprint) Genomic Evolution of Sars-Cov-2 in Molnupiravir-Treated Patients Compared to Paxlovid-Treated and Drug-Naïve Patients: A Proof-of-Concept Study
Mutation analysis showing over 5x greater within-host genetic diversity with molnupiravir compared to paxlovid or no treatment.
Oct 6
Brown et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofac527 Demographics and outcomes of initial phase of COVID-19 Medicines Delivery Units across 4 UK centres during peak B1.1.529 omicron epidemic: a service evaluation
101% higher hospitalization [p=0.51]. Retrospective 442 patients in the UK treated with molnupiravir, and 222 eligible but declining treatment, showing no significant difference in hospitalization. No group details are provided and the results are subject to confounding by in..
Oct 5
Suzuki et al., Research Square, doi:10.21203/rs.3.rs-2118653/v1 (Preprint) Real-world clinical outcomes of treatment with molnupiravir for patients with mild- to-moderate coronavirus disease 2019 during the Omicron variant pandemic
60% lower progression [p=0.01]. Retrospective 1,921 patients in Japan, showing lower progression with molnupiravir use.
Oct 1
Miranda et al., Environmental and Molecular Mutagenesis, doi:10.1002/em.22510 (In Vitro) Evaluation of the mutagenic effects of Molnupiravir and N4 ‐hydroxycytidine in bacterial and mammalian cells by HiFi sequencing
In Vitro genotoxocity study of molnupiravir showing dose dependent increased genome-wide mutation frequencies with mouse lymphoma L5178Y and human lymphoblastoid TK6 cells.
Sep 29
Arbel et al., New England Journal of Medicine, doi:10.1056/NEJMoa2204919 (date from earlier preprint) (Preprint) Molnupiravir Use and Severe Covid-19 Outcomes During the Omicron Surge
74% lower mortality [p=0.008] and 45% lower hospitalization [p=0.01]. Retrospective 19,868 patients eligible for molnupiravir treatment in Israel with 1,069 treated, showing lower mortality and hospitalization with treatment for the subgroup of patients ≥65, and higher mortality for patients 40-64. Authors ..
Sep 20
Najjar-Debbiny et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac781 Effectiveness of Molnupiravir in High Risk Patients: a Propensity Score Matched Analysis
19% lower mortality [p=0.48], 17% lower progression [p=0.34], and 25% lower severe cases [p=0.15]. PSM retrospective 2,661 molnupiravir patients in Israel, showing lower mortality and severe COVID-19, without statistical significance. Significant benefit was seen in some subgroups, and significant harm was seen in the <75 subgroup.
Sep 9
Kneidinger et al., Infection, doi:10.1007/s15010-022-01914-8 Outcome of lung transplant recipients infected with SARS-CoV-2/Omicron/B.1.1.529: a Nationwide German study
15% higher severe cases [p=0.71]. Retrospective 218 COVID+ lung transplant patients in Germany, showing no significant difference in severe cases with early molnupiravir use.
Aug 2
Lawrence et al., Research Square, doi:10.21203/rs.3.rs-1913200/v1 (Preprint) (meta analysis) Evaluation of publication bias for 12 clinical trials of molnupiravir to treat SARS-CoV-2 infection in 13,694 patients
Meta analysis of molnupiravir trials showing 12 registered RCTs in India with only one presented at a conference, and two issuing press releases suggesting failure. Authors find that ~90% of the global data on molnupiravir has not been pu..
Jul 29
Lieber et al., Nature Communications, doi:10.1038/s41467-022-32045-1 SARS-CoV-2 VOC type and biological sex affect molnupiravir efficacy in severe COVID-19 dwarf hamster model
Roborovski dwarf hamster and in vitro study finding molnupiravir efficacy varied significantly by SARS-CoV-2 variant in the hamster model, in contrast to no significant difference seen in cultured cells and human organoids. Efficacy for o..
Jul 24
Khoo et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(22)00644-2 (date from earlier preprint) Molnupiravir versus placebo in unvaccinated and vaccinated patients with early SARS-CoV-2 infection in the UK (AGILE CST-2): a randomised, placebo-controlled, double-blind, phase 2 trial
89% lower hospitalization [p=0.12], 12% worse recovery [p=0.74], and 23% improved viral clearance [p=0.07]. RCT 90 molnupiravir and 90 placebo patients, showing faster viral clearance with treatment, not reaching the pre-defined threshold for superiority and recommendation as a candidate for large scale evaluation.
Jul 6
Flisiak et al., Pharmacological Reports, doi:10.1007/s43440-022-00408-6 (date from earlier preprint) Real-world experience with molnupiravir during the period of SARS-CoV-2 Omicron variant dominance
39% lower mortality [p=0.03], 5% lower ventilation [p=1], and 1% longer hospitalization [p=0.97]. Retrospective 590 patients in Poland, 203 treated with mulnupiravir, showing lower mortality with treatment.
May 24
Yip et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac687 (date from earlier preprint) Impact of the use of oral antiviral agents on the risk of hospitalization in community COVID-19 patients
12% higher combined mortality/ICU admission [p=0.66] and 17% higher hospitalization [p=0.06]. Propensity score weighted retrospective of 93,883 outpatients in Hong Kong, 5,808 treated with molnupiravir and 4,921 treated with paxlovid, showing higher hospitalization and higher combined mortality/mechanical ventilation/ICU admission..
May 20
Wong et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(22)00507-2 (date from earlier preprint) Real-world effectiveness of early molnupiravir or nirmatrelvir–ritonavir in hospitalised patients with COVID-19 without supplemental oxygen requirement on admission during Hong Kong's omicron BA.2 wave: a retrospective cohort study
52% lower mortality [p<0.0001], 58% lower ventilation [p=0.06], 40% lower progression [p<0.0001], and 6% shorter hospitalization [p=0.03]. PSM retrospective 40,776 patients in Hong Kong, showing lower mortality and lower combined mortality, ventilation, ICU, and oxygen therapy with molnupiravir treatment.
May 17
Rosenke et al., JCI Insight, doi:10.1172/jci.insight.160108 Molnupiravir inhibits SARS-CoV-2 variants including Omicron in the hamster model
Syrian hamster study showing efficacy of molnupiravir for multiple variants including omicron.
Apr 18
Hadj Hassine et al., Viruses, doi:10.3390/v14040841 (Review) Lethal Mutagenesis of RNA Viruses and Approved Drugs with Antiviral Mutagenic Activity
Review of lethal mutagenesis for RNA viruses, as used by molnupiravir, favipiravir, and ribavirin. Authors note the potential for permanently modifying the genomes of patients while causing teratogenicity or embryotoxicity, and the potent..
Apr 8
Lee, T. (News) PANORAMIC recruitment analysis
Analysis of the PANORAMIC trial recuitment suggesting that if the trial shows efficacy, the NNT will be >200.
Mar 11
Thorlund et al., The American Journal of Tropical Medicine and Hygiene, doi:10.4269/ajtmh.21-1339 (Review) Making Statistical Sense of the Molnupiravir MOVe-OUT Clinical Trial
Discussion of concerns with the MOVe-OUT trial, including the reversal of the treatment effect post-interim analysis.
Feb 24
Tippabhotla et al., SSRN Electronic Journal, doi:10.2139/ssrn.4042673 Efficacy and Safety of Molnupiravir for the Treatment of Non-Hospitalized Adults With Mild COVID-19: A Randomized, Open-Label, Parallel-Group Phase 3 Trial
46% lower hospitalization [p=0.26], 46% better improvement [p<0.0001], and 59% improved viral clearance [p<0.0001]. RCT 1,220 patients in India, showing lower risk of hospitalization and improved recovery with treatment. CTRI/2021/07/034588.
Feb 3
Swanstrom et al., Science, doi:10.1126/science.abn0048 (Review) Lethal mutagenesis as an antiviral strategy
Review of the unknown long-term cancer, reproductive, and escape variant creation risks of molnupiravir. For more discussion see [twitter.com, twitter.com, twitter.com].
Jan 28
Waters et al., Environmental and Molecular Mutagenesis, doi:10.1002/em.22471 (Review) Human genetic risk of treatment with antiviral nucleoside analog drugs that induce lethal mutagenesis: the special case of molnupiravir
Review of antiviral nucleoside analog drugs that induce lethal mutagenesis, including molnupiravir and favipiravir, and the potential mutagenic risks to human DNA and human mitochondrial DNA. Author recommends monitoring for mutagenicity,..
Dec 16
2021
Arribas et al., NEJM Evidence, doi:10.1056/EVIDoa2100044 Randomized Trial of Molnupiravir or Placebo in Patients Hospitalized with Covid-19
282% higher mortality [p=0.31], 1% improved recovery [p=0.96], and 12% improved viral clearance [p=0.57]. RCT 304 hospitalized patients, 218 treated with molnupiravir, showing no significant differences. MOVe-IN MK-4482-001. NCT04575584.
Dec 16
2021
Jayk Bernal et al., New England Journal of Medicine, doi:10.1056/NEJMoa2116044 Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients
89% lower mortality [p=0.01] and 30% lower combined mortality/hospitalization [p=0.05]. MOVe-OUT RCT, showing significantly lower risk of hospitalization or death. In subgroup analysis efficacy was much lower with the delta variant. NCT04575597. Discussion of concerns with this trial can be found at [defyccc.com, trialsitene..
Dec 3
2021
Anonymous, Authorea, doi:10.22541/au.163854323.34557301/v1 (Review) (Preprint) Treating a Pandemic Respiratory Disease with a Mutagen is a Doomsday Scenario
Review of molnupiravir's mutagenic mechanism of action, and analysis of the increased probability of creating dangerous variants.
Nov 6
2021
Goldstein, L., TrialSite News (Review) (News) Molnupiravir: mutagenic, carcinogenic, authorized in the UK
Discussion of concerns with molnupiravir and the MOVe-OUT trial. Author notes that results showing bone marrow toxicity in dogs were mentioned in this preprint [medrxiv.org], but removed from the journal version [journals.asm.org]. Some a..
Oct 9
2021
Reuters (News) Two Indian drugmakers to end trials of generic Merck pill for moderate COVID-19
no change in recovery [p=1]. Trial CTRI/2021/08/035424 for moderate condition patients has been reported as terminated for futility. Results are not available yet [trialsearch.who.int].
Oct 9
2021
Reuters (News) Two Indian drugmakers to end trials of generic Merck pill for moderate COVID-19
no change in recovery [p=1]. Trial CTRI/2021/05/033864 for moderate condition patients has been reported as terminated for futility. Results are not available yet [trialsearch.who.int].
Sep 13
2021
Malone et al., Nature Structural & Molecular Biology, doi:10.1038/s41594-021-00657-8 (Review) Molnupiravir: coding for catastrophe
Review of recent studies on molnupiravir's mechanism of lethal mutagenesis. Authors note that potential off-target effects require further investigation, because molnupiravir may be mutagenic to host DNA during host DNA replication.
Aug 27
2021
Khoo et al., Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkab318 Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a Phase I, open-label, dose-escalating, randomized controlled study
33% worse recovery [p=0.63]. Dose and safety study of molnupiravir with 18 participants, finding no serious adverse events in short-term followup. There was no significant difference in clinical outcomes. NCT04746183.
Jul 21
2021
Optimus Press Release (News) Optimus announces Interim Clinical Results from Phase III Clinical Trials of Molnupiravir conducted in India
58% improved viral clearance [p<0.0001]. Interim report on CTRI/2021/06/033992, showing faster viral clearance. Event counts are approximate, the press release only provides percentages.
Jul 9
2021
Hetero Press Release Hetero Announces Interim Clinical Results from Phase III Clinical Trials of Molnupiravir conducted in India
70% lower hospitalization [p=0.003] and 33% faster recovery [p=0.0001]. Interim results for CTRI/2021/05/033739, showing lower mortality and faster recovery.
Jul 9
2021
Abdelnabi et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab361 Molnupiravir Inhibits Replication of the Emerging SARS-CoV-2 Variants of Concern in a Hamster Infection Model
Hamster study showing molnupiravir effective against the original, B.1.1.7, and B.1.351 variants.
Jun 18
2021
Fischer et al., medRxiv, doi:10.1101/2021.06.17.21258639 (Preprint) Molnupiravir, an Oral Antiviral Treatment for COVID-19
77% lower mortality [p=0.31] and 49% improved viral clearance [p=0.12]. RCT 202 outpatients in the USA showing significantly faster viral clearance, but no significant differences in symptom duration or severity. NCT04405570.
May 7
2021
Zhou et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab247 (In Vitro) β-D-N4-hydroxycytidine Inhibits SARS-CoV-2 Through Lethal Mutagenesis But Is Also Mutagenic To Mammalian Cells
In Vitro study showing that NHC (initial metabolite of molnupiravir) has high antiviral activity against SARS-CoV-2, but also shows host mutational activity in an animal cell culture assay. Authors note the concern that mutations in host ..
Apr 15
2021
Merck, News Release (Preprint) Merck and Ridgeback Biotherapeutics Provide Update on Progress of Clinical Development Program for Molnupiravir, an Investigational Oral Therapeutic for the Treatment of Mild-to-Moderate COVID-19
News release reporting that the trial of molnupiravir with hospitalized patients (NCT04575584) has been discontinued because data indicates it is unlikely to demonstrate a clinical benefit in hospitalized patients. Results are not availab..
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