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Molnupiravir COVID-19 studies. There is substantial positive publication bias. Two trials (CTRI/2021/05/033864, and CTRI/2021/08/0354242) have reported no significant efficacy, however the results have not been published yet. Concerns have been raised that the mutagenic mechanism of action may create dangerous variants or cause cancer. Recently added: Arribas. Molnupiravir has been officially adopted for early treatment in 4 countries. Submit updates/corrections.
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Dec 16
Late Arribas et al., NEJM Evidence, doi:10.1056/EVIDoa2100044 (Peer Reviewed)
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
Early Jayk Bernal et al., New England Journal of Medicine, doi:10.1056/NEJMoa2116044 (Peer Reviewed)
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 [1, 2]. See also: [3, 4].
Dec 3
N/A Anonymous, Authorea, doi:10.22541/au.163854323.34557301/v1 (Review) (Preprint)
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
Review Goldstein, L., TrialSite News (Review) (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 [1], but removed from the journal version [2]. Some additional details were pr..
Oct 9
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 [1].
Oct 9
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 [1].
Sep 13
Review Malone et al., Nature Structural & Molecular Biology, doi:10.1038/s41594-021-00657-8 (Review) (Peer Reviewed)
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
Early Khoo et al., Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkab318 (Peer Reviewed)
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
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
Early Hetero Press Release (Peer Reviewed)
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
Animal Abdelnabi et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab361 (Peer Reviewed)
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
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
In Vitro Zhou et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab247 (Peer Reviewed) (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
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. Elimination of COVID-19 is a race against viral evolution. 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. WCH and FLCCC provide treatment protocols.
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