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Angélica Jayk Bernal, Monica Maria Gomes da Silva, Dany Badibanga Musungaie, E. A. Kovalchuk, Antonio Gonzalez, Virginia Delos Reyes, Alejandro Martín‐Quirós, Yoseph Caraco, Angela Williams‐Diaz, Michelle L. Hoffman Brown and 12 more
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 [CI], -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% CI, -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.).
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Bernal, A. J., Silva, M. M. G. D., Musungaie, D. B., Kovalchuk, E. A., Gonzalez, A., Reyes, V. D., Martín‐Quirós, A., Caraco, Y., Williams‐Diaz, A., Brown, M. L. H., Du, J., Pedley, A., Assaid, C. A., Strizki, J., Grobler, J. A., Shamsuddin, H. H., Tipping, R., Wan, H. I., Paschke, A. A., … Anda, C. S. D. (2021). Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients. New England Journal of Medicine, 386(6), 509–520. https://doi.org/10.1056/nejmoa2116044
Bernal, Angélica Jayk, et al. "Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients." New England Journal of Medicine, vol. 386, no. 6, 2021, pp. 509–520, https://doi.org/10.1056/nejmoa2116044.
Bernal, Angélica Jayk, Monica Maria Gomes da Silva, Dany Badibanga Musungaie, E. A. Kovalchuk, Antonio Gonzalez, Virginia Delos Reyes, Alejandro Martín‐Quirós, et al. "Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients." New England Journal of Medicine 386, no. 6 (2021): 509–520. https://doi.org/10.1056/nejmoa2116044.
Bernal A. J., Silva M. M. G. D., Musungaie D. B. [и др.] Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients // New England Journal of Medicine. — 2021. — Vol. 386, № 6. — P. 509–520. — URL: https://doi.org/10.1056/nejmoa2116044
@article{bernal2021molnupiravir,
title = {{Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients}},
author = {Angélica Jayk Bernal and Monica Maria Gomes da Silva and Dany Badibanga Musungaie and E. A. Kovalchuk and Antonio Gonzalez and Virginia Delos Reyes and Alejandro Martín‐Quirós and Yoseph Caraco and Angela Williams‐Diaz and Michelle L. Hoffman Brown and Jiejun Du and Alison Pedley and Christopher A. Assaid and Julie Strizki and Jay A. Grobler and Hala H. Shamsuddin and Robert Tipping and Hong I. Wan and Amanda A. Paschke and Joan R. Butterton and Matthew G. Johnson and Carisa S. De Anda},
journal = {New England Journal of Medicine},
year = {2021},
volume = {386},
number = {6},
pages = {509--520},
doi = {10.1056/nejmoa2116044},
url = {https://doi.org/10.1056/nejmoa2116044}
}TY - JOUR AU - Bernal, Angélica Jayk AU - Silva, Monica Maria Gomes da AU - Musungaie, Dany Badibanga AU - Kovalchuk, E. A. AU - Gonzalez, Antonio AU - Reyes, Virginia Delos AU - Martín‐Quirós, Alejandro AU - Caraco, Yoseph AU - Williams‐Diaz, Angela AU - Brown, Michelle L. Hoffman AU - Du, Jiejun AU - Pedley, Alison AU - Assaid, Christopher A. AU - Strizki, Julie AU - Grobler, Jay A. AU - Shamsuddin, Hala H. AU - Tipping, Robert AU - Wan, Hong I. AU - Paschke, Amanda A. AU - Butterton, Joan R. AU - Johnson, Matthew G. AU - Anda, Carisa S. De TI - Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients JO - New England Journal of Medicine VL - 386 IS - 6 SP - 509 EP - 520 PY - 2021 DA - 2021/12/16 DO - 10.1056/nejmoa2116044 UR - https://doi.org/10.1056/nejmoa2116044 ER -
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