Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients

Jayk Bernal et al., New England Journal of Medicine, doi:10.1056/NEJMoa2116044, MOVe-OUT, NCT04575597, Dec 2021

https://c19early.org/jaykbernal.html

Systematic review and meta analysis of outpatient RCTs, showing hospitalization RR 0.75 [0.57-0.97]. For discussion see1.

Potential risks of molnupiravir include the creation of dangerous variants, and mutagenicity, carcinogenicity, teratogenicity, and embryotoxicity2-15. Multiple analyses have identified variants potentially created by molnupiravir16-20.

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risk of death, 89.0% lower, RR 0.11, p = 0.01, treatment 1 of 709 (0.1%), control 9 of 699 (1.3%), NNT 87.

risk of death/hospitalization, 30.4% lower, RR 0.70, p = 0.05, treatment 48 of 709 (6.8%), control 68 of 699 (9.7%), NNT 34, primary outcome.

risk of death/hosp. (gamma variant), 94.1% lower, RR 0.06, p = 0.004, treatment 0 of 37 (0.0%), control 9 of 47 (19.1%), NNT 5.2, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).

risk of death/hosp. (mu variant), 49.5% lower, RR 0.50, p = 0.15, treatment 6 of 75 (8.0%), control 13 of 82 (15.9%), NNT 13.

risk of death/hosp. (delta variant), 23.7% lower, RR 0.76, p = 0.41, treatment 18 of 237 (7.6%), control 22 of 221 (10.0%), NNT 42.

risk of death/hosp. (other variants), 42.2% lower, RR 0.58, p = 0.36, treatment 5 of 47 (10.6%), control 7 of 38 (18.4%), NNT 13.

recovery time, 14.5% lower, HR 0.85, p = 0.02, treatment 709, control 699, inverted to make HR<1 favor treatment, sustained alleviation.

recovery time, 19.4% lower, HR 0.81, p < 0.001, treatment 709, control 699, inverted to make HR<1 favor treatment, alleviation.

recovery time, 15.3% lower, HR 0.85, p = 0.01, treatment 709, control 699, inverted to make HR<1 favor treatment, resolution of distinctive symptoms.

recovery time, 13.8% lower, HR 0.86, p = 0.02, treatment 709, control 699, inverted to make HR<1 favor treatment, first alleviation of distinctive symptoms.

relative improvement in viral titer, 4.2% better, RR 0.96, p = 0.20, treatment mean 3.3 (±1.74) n=518, control mean 3.16 (±1.77) n=510, mid-recovery, day 10.

relative improvement in viral titer, 2.0% worse, RR 1.02, p = 0.48, treatment mean 4.0 (±1.81) n=516, control mean 4.08 (±1.84) n=513, day 29.

relative improvement in viral titer, 1.1% better, RR 0.99, p = 0.74, treatment mean 3.73 (±1.88) n=515, control mean 3.69 (±1.91) n=506, day 15.

relative improvement in viral titer, 13.3% better, RR 0.87, p = 0.002, treatment mean 2.25 (±1.63) n=558, control mean 1.95 (±1.58) n=547, day 5.

relative improvement in viral titer, 17.1% better, RR 0.83, p = 0.02, treatment mean 1.17 (±1.45) n=570, control mean 0.97 (±1.35) n=570, day 3.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

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Jayk Bernal et al., 16 Dec 2021, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, 22 authors, study period 6 May, 2021 - 2 October, 2021, average treatment delay 4.0 days, trial NCT04575597 (history) (MOVe-OUT).

This Paper Molnupiravir All

Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients

Angélica Jayk Bernal, Monica M Gomes Da Silva, Dany B Musungaie, Evgeniy Kovalchuk, Antonio Gonzalez, Virginia Delos Reyes, Alejandro Martín-Quirós, Yoseph Caraco, Angela Williams-Diaz, Michelle L Brown, Jiejun Du, Alison Pedley, Christopher Assaid, Julie Strizki, Jay A Grobler, Hala H Shamsuddin, Robert Tipping, Hong Wan, Amanda Paschke, Joan R Butterton, Matthew G Johnson, Carisa De Anda

New England Journal of Medicine, doi:10.1056/nejmoa2116044

BACKGROUND New treatments are needed to reduce the risk of progression of coronavirus disease 2019 (Covid-19). Molnupiravir is an oral, small-molecule antiviral prodrug that is active against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). METHODS We conducted a phase 3, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of treatment with molnupiravir started within 5 days after the onset of signs or symptoms in nonhospitalized, unvaccinated adults with mild-to-moderate, laboratory-confirmed Covid-19 and at least one risk factor for severe Covid-19 illness. Participants in the trial were randomly assigned to receive 800 mg of molnupiravir or placebo twice daily for 5 days. The primary efficacy end point was the incidence hospitalization or death at day 29; the incidence of adverse events was the primary safety end point. A planned interim analysis was performed when 50% of 1550 participants (target enrollment) had been followed through day 29. RESULTS A total of 1433 participants underwent randomization; 716 were assigned to receive molnupiravir and 717 to receive placebo. With the exception of an imbalance in sex, baseline characteristics were similar in the two groups. The superiority of molnupiravir was demonstrated at the interim analysis; the risk of hospitalization for any cause or death through day 29 was lower with molnupiravir (28 of 385 participants [7.3%]) than with placebo (53 of 377 [14.1%]) (difference, −6.8 percentage points; 95% confidence interval, −11.3 to −2.4; P = 0.001). In the analysis of all participants who had undergone randomization, the percentage of participants who were hospitalized or died through day 29 was lower in the molnupiravir group than in the placebo group (6.8% [48 of 709] vs. 9.7% [68 of 699]; difference, −3.0 percentage points; 95% confidence interval, −5.9 to −0.1). Results of subgroup analyses were largely consistent with these overall results; in some subgroups, such as patients with evidence of previous SARS-CoV-2 infection, those with low baseline viral load, and those with diabetes, the point estimate for the difference favored placebo. One death was reported in the molnupiravir group and 9 were reported in the placebo group through day 29. Adverse events were reported in 216 of 710 participants (30.4%) in the molnupiravir group and 231 of 701 (33.0%) in the placebo group. CONCLUSIONS Early treatment with molnupiravir reduced the risk of hospitalization or death in at-risk, unvaccinated adults with Covid-19. (Funded by Merck Sharp and Dohme; MOVe-OUT ClinicalTrials.gov number, NCT04575597.

Supported by Merck Sharp and Dohme, a subsidiary of Merck, Kenilworth, NJ. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. A data sharing statement provided by the authors is available with the full text of this article at NEJM.org. We thank the participants and their families and caregivers for their participation in this trial and Wendy Painter, M.D., and Wayne Holman, M.D., both of Ridgeback Biotherapeutics, Miami, for scientific discussions. Medical writing assistance was provided by Dominik J. Wolf, M.Sc., who wrote the first draft of the manuscript under guidance from the authors, and editorial assistance was provided by Karyn Davis, B.S., both of Merck Sharp and Dohme, a subsidiary of Merck, Kenilworth, NJ. n engl j med nejm.org Appendix

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DOI record: { "DOI": "10.1056/nejmoa2116044", "ISSN": [ "0028-4793", "1533-4406" ], "URL": "http://dx.doi.org/10.1056/nejmoa2116044", "alternative-id": [ "10.1056/NEJMoa2116044" ], "author": [ { "affiliation": [ { "name": "From IMAT Oncomédica, Monteria, Colombia (A.J.B.); the Department of Public Health, Hospital de Clínicas, Federal University of Paraná, Curitiba, Brazil (M.M.G.S.); Jongaie Research, Pretoria, South Africa (D.B.M.); Medical Research Institute, St. Petersburg, Russia (E.K.); Advanced Research for Health Improvement, Immokalee, FL (A.G.); Lung Center of the Philippines, Quezon City, Philippines (V.D.R.); Hospital Universitario La Paz, IdiPAZ, Madrid (A.M.-Q.); Clinical Pharmacology Unit, Hadassah–Hebrew..." } ], "family": "Jayk Bernal", "given": "Angélica", "sequence": "first" }, { "affiliation": [ { "name": "From IMAT Oncomédica, Monteria, Colombia (A.J.B.); the Department of Public Health, Hospital de Clínicas, Federal University of Paraná, Curitiba, Brazil (M.M.G.S.); Jongaie Research, Pretoria, South Africa (D.B.M.); Medical Research Institute, St. Petersburg, Russia (E.K.); Advanced Research for Health Improvement, Immokalee, FL (A.G.); Lung Center of the Philippines, Quezon City, Philippines (V.D.R.); Hospital Universitario La Paz, IdiPAZ, Madrid (A.M.-Q.); Clinical Pharmacology Unit, Hadassah–Hebrew..." } ], "family": "Gomes da Silva", "given": "Monica M.", "sequence": "additional" }, { "affiliation": [ { "name": "From IMAT Oncomédica, Monteria, Colombia (A.J.B.); the Department of Public Health, Hospital de Clínicas, Federal University of Paraná, Curitiba, Brazil (M.M.G.S.); Jongaie Research, Pretoria, South Africa (D.B.M.); Medical Research Institute, St. Petersburg, Russia (E.K.); Advanced Research for Health Improvement, Immokalee, FL (A.G.); Lung Center of the Philippines, Quezon City, Philippines (V.D.R.); Hospital Universitario La Paz, IdiPAZ, Madrid (A.M.-Q.); Clinical Pharmacology Unit, Hadassah–Hebrew..." } ], "family": "Musungaie", "given": "Dany B.", "sequence": "additional" }, { "affiliation": [ { "name": "From IMAT Oncomédica, Monteria, Colombia (A.J.B.); the Department of Public Health, Hospital de Clínicas, Federal University of Paraná, Curitiba, Brazil (M.M.G.S.); Jongaie Research, Pretoria, South Africa (D.B.M.); Medical Research Institute, St. Petersburg, Russia (E.K.); Advanced Research for Health Improvement, Immokalee, FL (A.G.); Lung Center of the Philippines, Quezon City, Philippines (V.D.R.); Hospital Universitario La Paz, IdiPAZ, Madrid (A.M.-Q.); Clinical Pharmacology Unit, Hadassah–Hebrew..." } ], "family": "Kovalchuk", "given": "Evgeniy", "sequence": "additional" }, { "affiliation": [ { "name": "From IMAT Oncomédica, Monteria, Colombia (A.J.B.); the Department of Public Health, Hospital de Clínicas, Federal University of Paraná, Curitiba, Brazil (M.M.G.S.); Jongaie Research, Pretoria, South Africa (D.B.M.); Medical Research Institute, St. Petersburg, Russia (E.K.); Advanced Research for Health Improvement, Immokalee, FL (A.G.); Lung Center of the Philippines, Quezon City, Philippines (V.D.R.); Hospital Universitario La Paz, IdiPAZ, Madrid (A.M.-Q.); 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Advanced Research for Health Improvement, Immokalee, FL (A.G.); Lung Center of the Philippines, Quezon City, Philippines (V.D.R.); Hospital Universitario La Paz, IdiPAZ, Madrid (A.M.-Q.); Clinical Pharmacology Unit, Hadassah–Hebrew..." } ], "family": "Martín-Quirós", "given": "Alejandro", "sequence": "additional" }, { "affiliation": [ { "name": "From IMAT Oncomédica, Monteria, Colombia (A.J.B.); the Department of Public Health, Hospital de Clínicas, Federal University of Paraná, Curitiba, Brazil (M.M.G.S.); Jongaie Research, Pretoria, South Africa (D.B.M.); Medical Research Institute, St. Petersburg, Russia (E.K.); Advanced Research for Health Improvement, Immokalee, FL (A.G.); Lung Center of the Philippines, Quezon City, Philippines (V.D.R.); Hospital Universitario La Paz, IdiPAZ, Madrid (A.M.-Q.); Clinical Pharmacology Unit, Hadassah–Hebrew..." } ], "family": "Caraco", "given": "Yoseph", "sequence": "additional" }, { "affiliation": [ { "name": "From IMAT Oncomédica, Monteria, Colombia (A.J.B.); the Department of Public Health, Hospital de Clínicas, Federal University of Paraná, Curitiba, Brazil (M.M.G.S.); Jongaie Research, Pretoria, South Africa (D.B.M.); Medical Research Institute, St. Petersburg, Russia (E.K.); Advanced Research for Health Improvement, Immokalee, FL (A.G.); Lung Center of the Philippines, Quezon City, Philippines (V.D.R.); Hospital Universitario La Paz, IdiPAZ, Madrid (A.M.-Q.); Clinical Pharmacology Unit, Hadassah–Hebrew..." } ], "family": "Williams-Diaz", "given": "Angela", "sequence": "additional" }, { "affiliation": [ { "name": "From IMAT Oncomédica, Monteria, Colombia (A.J.B.); the Department of Public Health, Hospital de Clínicas, Federal University of Paraná, Curitiba, Brazil (M.M.G.S.); Jongaie Research, Pretoria, South Africa (D.B.M.); Medical Research Institute, St. Petersburg, Russia (E.K.); Advanced Research for Health Improvement, Immokalee, FL (A.G.); Lung Center of the Philippines, Quezon City, Philippines (V.D.R.); Hospital Universitario La Paz, IdiPAZ, Madrid (A.M.-Q.); Clinical Pharmacology Unit, Hadassah–Hebrew..." } ], "family": "Brown", "given": "Michelle L.", "sequence": "additional" }, { "affiliation": [ { "name": "From IMAT Oncomédica, Monteria, Colombia (A.J.B.); the Department of Public Health, Hospital de Clínicas, Federal University of Paraná, Curitiba, Brazil (M.M.G.S.); Jongaie Research, Pretoria, South Africa (D.B.M.); Medical Research Institute, St. Petersburg, Russia (E.K.); Advanced Research for Health Improvement, Immokalee, FL (A.G.); Lung Center of the Philippines, Quezon City, Philippines (V.D.R.); Hospital Universitario La Paz, IdiPAZ, Madrid (A.M.-Q.); Clinical Pharmacology Unit, Hadassah–Hebrew..." } ], "family": "Du", "given": "Jiejun", "sequence": "additional" }, { "affiliation": [ { "name": "From IMAT Oncomédica, Monteria, Colombia (A.J.B.); the Department of Public Health, Hospital de Clínicas, Federal University of Paraná, Curitiba, Brazil (M.M.G.S.); Jongaie Research, Pretoria, South Africa (D.B.M.); Medical Research Institute, St. Petersburg, Russia (E.K.); Advanced Research for Health Improvement, Immokalee, FL (A.G.); Lung Center of the Philippines, Quezon City, Philippines (V.D.R.); Hospital Universitario La Paz, IdiPAZ, Madrid (A.M.-Q.); Clinical Pharmacology Unit, Hadassah–Hebrew..." } ], "family": "Pedley", "given": "Alison", "sequence": "additional" }, { "affiliation": [ { "name": "From IMAT Oncomédica, Monteria, Colombia (A.J.B.); the Department of Public Health, Hospital de Clínicas, Federal University of Paraná, Curitiba, Brazil (M.M.G.S.); Jongaie Research, Pretoria, South Africa (D.B.M.); Medical Research Institute, St. Petersburg, Russia (E.K.); Advanced Research for Health Improvement, Immokalee, FL (A.G.); Lung Center of the Philippines, Quezon City, Philippines (V.D.R.); Hospital Universitario La Paz, IdiPAZ, Madrid (A.M.-Q.); Clinical Pharmacology Unit, Hadassah–Hebrew..." } ], "family": "Assaid", "given": "Christopher", "sequence": "additional" }, { "affiliation": [ { "name": "From IMAT Oncomédica, Monteria, Colombia (A.J.B.); the Department of Public Health, Hospital de Clínicas, Federal University of Paraná, Curitiba, Brazil (M.M.G.S.); Jongaie Research, Pretoria, South Africa (D.B.M.); Medical Research Institute, St. Petersburg, Russia (E.K.); Advanced Research for Health Improvement, Immokalee, FL (A.G.); Lung Center of the Philippines, Quezon City, Philippines (V.D.R.); Hospital Universitario La Paz, IdiPAZ, Madrid (A.M.-Q.); Clinical Pharmacology Unit, Hadassah–Hebrew..." } ], "family": "Strizki", "given": "Julie", "sequence": "additional" }, { "affiliation": [ { "name": "From IMAT Oncomédica, Monteria, Colombia (A.J.B.); the Department of Public Health, Hospital de Clínicas, Federal University of Paraná, Curitiba, Brazil (M.M.G.S.); Jongaie Research, Pretoria, South Africa (D.B.M.); Medical Research Institute, St. Petersburg, Russia (E.K.); Advanced Research for Health Improvement, Immokalee, FL (A.G.); Lung Center of the Philippines, Quezon City, Philippines (V.D.R.); Hospital Universitario La Paz, IdiPAZ, Madrid (A.M.-Q.); 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