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Other Treatments Global Adoption
 
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:
Najjar-Debbiny
Kneidinger
Lawrence
Lieber
Khoo
Flisiak
Yip.
Molnupiravir has been officially adopted for early treatment in 12 countries. Submit updates/corrections.
Sep 20
Early Najjar-Debbiny et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac781
death, ↓19.0%, p=0.48
Effectiveness of Molnupiravir in High Risk Patients: a Propensity Score Matched Analysis
Details   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
Early Kneidinger et al., Infection, doi:10.1007/s15010-022-01914-8
severe case, ↑15.1%, p=0.71
Outcome of lung transplant recipients infected with SARS-CoV-2/Omicron/B.1.1.529: a Nationwide German study
Details   Retrospective 218 COVID+ lung transplant patients in Germany, showing no significant difference in severe cases with early molnupiravir use.
Aug 2
Meta Lawrence et al., Research Square, doi:10.21203/rs.3.rs-1913200/v1 (Preprint) (meta analysis)
meta-analysis
Evaluation of publication bias for 12 clinical trials of molnupiravir to treat SARS-CoV-2 infection in 13,694 patients
Details   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
Animal Lieber et al., Nature Communications, doi:10.1038/s41467-022-32045-1
animal study
SARS-CoV-2 VOC type and biological sex affect molnupiravir efficacy in severe COVID-19 dwarf hamster model
Details   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
Early Khoo et al., medRxiv, doi:10.1101/2022.07.20.22277797 (Preprint)
oxygen, ↓66.7%, p=1.00
A Randomised-Controlled Phase 2 trial of Molnupiravir in Unvaccinated and Vaccinated Individuals with Early SARS-CoV-2
Details   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. The supplementary figures and..
Jul 6
Early Flisiak et al., Pharmacological Reports, doi:10.1007/s43440-022-00408-6 (preprint 7/6/2022)
death, ↓39.5%, p=0.03
Real-world experience with molnupiravir during the period of SARS-CoV-2 Omicron variant dominance
Details   Retrospective 590 patients in Poland, 203 treated with mulnupiravir, showing lower mortality with treatment.
May 24
Early Yip et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac687 (preprint 5/24/2022)
death/ICU, ↑12.0%, p=0.66
Impact of the use of oral antiviral agents on the risk of hospitalization in community COVID-19 patients
Details   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
Early Wong et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(22)00507-2 (preprint 5/20/2022)
death, ↓52.0%, p<0.0001
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
Details   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
Animal Rosenke et al., JCI Insight, doi:10.1172/jci.insight.160108
animal study
Molnupiravir inhibits SARS-CoV-2 variants including Omicron in the hamster model
Details   Syrian hamster study showing efficacy of molnupiravir for multiple variants including omicron.
Apr 18
Review Hadj Hassine et al., Viruses, doi:10.3390/v14040841 (Review)
review
Lethal Mutagenesis of RNA Viruses and Approved Drugs with Antiviral Mutagenic Activity
Details   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
Meta Lee, T. (News)
news
PANORAMIC recruitment analysis
Details   Analysis of the PANORAMIC trial recuitment suggesting that if the trial shows efficacy, the NNT will be >200.
Mar 11
Review Thorlund et al., The American Journal of Tropical Medicine and Hygiene, doi:10.4269/ajtmh.21-1339 (Review)
review
Making Statistical Sense of the Molnupiravir MOVe-OUT Clinical Trial
Details   Discussion of concerns with the MOVe-OUT trial, including the reversal of the treatment effect post-interim analysis.
Feb 24
Early Tippabhotla et al., SSRN Electronic Journal, doi:10.2139/ssrn.4042673
hosp., ↓46.2%, p=0.26
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
Details   RCT 1,220 patients in India, showing lower risk of hospitalization and improved recovery with treatment. CTRI/2021/07/034588.
Feb 3
Review Swanstrom et al., Science, doi:10.1126/science.abn0048 (Review)
review
Lethal mutagenesis as an antiviral strategy
Details   Review of the unknown long-term cancer, reproductive, and escape variant creation risks of molnupiravir. For more discussion see .
Jan 28
Review Waters et al., Environmental and Molecular Mutagenesis, doi:10.1002/em.22471 (Review)
review
Human genetic risk of treatment with antiviral nucleoside analog drugs that induce lethal mutagenesis: the special case of molnupiravir
Details   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
Late Arribas et al., NEJM Evidence, doi:10.1056/EVIDoa2100044
death, ↑281.9%, p=0.31
Randomized Trial of Molnupiravir or Placebo in Patients Hospitalized with Covid-19
Details   RCT 304 hospitalized patients, 218 treated with molnupiravir, showing no significant differences. MOVe-IN MK-4482-001. NCT04575584.
Dec 16
2021
Early Jayk Bernal et al., New England Journal of Medicine, doi:10.1056/NEJMoa2116044
death, ↓89.0%, p=0.01
Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients
Details   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 . See also: .
Dec 3
2021
N/A Anonymous, Authorea, doi:10.22541/au.163854323.34557301/v1 (Review) (Preprint)
review
Treating a Pandemic Respiratory Disease with a Mutagen is a Doomsday Scenario
Details   Review of molnupiravir's mutagenic mechanism of action, and analysis of the increased probability of creating dangerous variants.
Nov 6
2021
Review Goldstein, L., TrialSite News (Review) (News)
news
Molnupiravir: mutagenic, carcinogenic, authorized in the UK
Details   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 , but removed from the journal version . Some additional details were provided..
Oct 9
2021
Late Reuters (News)
improv., 0.0%, p=1.00
Two Indian drugmakers to end trials of generic Merck pill for moderate COVID-19
Details   Trial CTRI/2021/08/035424 for moderate condition patients has been reported as terminated for futility. Results are not available yet .
Oct 9
2021
Late Reuters (News)
improv., 0.0%, p=1.00
Two Indian drugmakers to end trials of generic Merck pill for moderate COVID-19
Details   Trial CTRI/2021/05/033864 for moderate condition patients has been reported as terminated for futility. Results are not available yet .
Sep 13
2021
Review Malone et al., Nature Structural & Molecular Biology, doi:10.1038/s41594-021-00657-8 (Review)
review
Molnupiravir: coding for catastrophe
Details   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
Early Khoo et al., Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkab318
no recov., ↑33.3%, p=0.63
Optimal dose and safety of molnupiravir in patients with early SARS-CoV-2: a Phase I, open-label, dose-escalating, randomized controlled study
Details   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
Early Optimus Press Release (News)
viral+, ↓58.0%, p<0.0001
Optimus announces Interim Clinical Results from Phase III Clinical Trials of Molnupiravir conducted in India
Details   Interim report on CTRI/2021/06/033992, showing faster viral clearance. Event counts are approximate, the press release only provides percentages.
Jul 9
2021
Early Hetero Press Release
hosp., ↓69.6%, p=0.003
Hetero Announces Interim Clinical Results from Phase III Clinical Trials of Molnupiravir conducted in India
Details   Interim results for CTRI/2021/05/033739, showing lower mortality and faster recovery.
Jul 9
2021
Animal Abdelnabi et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab361
animal study
Molnupiravir Inhibits Replication of the Emerging SARS-CoV-2 Variants of Concern in a Hamster Infection Model
Details   Hamster study showing molnupiravir effective against the original, B.1.1.7, and B.1.351 variants.
Jun 18
2021
Early Fischer et al., medRxiv, doi:10.1101/2021.06.17.21258639 (Preprint)
death, ↓76.5%, p=0.31
Molnupiravir, an Oral Antiviral Treatment for COVID-19
Details   RCT 202 outpatients in the USA showing significantly faster viral clearance, but no significant differences in symptom duration or severity. NCT04405570.
May 7
2021
In Vitro Zhou et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab247 (In Vitro)
In Vitro
β-D-N4-hydroxycytidine Inhibits SARS-CoV-2 Through Lethal Mutagenesis But Is Also Mutagenic To Mammalian Cells
Details   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
Late 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
Details   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..
Please send us corrections, updates, or comments. Vaccines and treatments are both valuable and complementary. All practical, effective, and safe means should be used. No treatment, vaccine, or intervention is 100% available and effective for all current and future variants. Denying the efficacy of any method increases mortality, morbidity, collateral damage, and the risk of endemic status. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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