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. 2021 Nov-Dec;15(6):102329.
doi: 10.1016/j.dsx.2021.102329. Epub 2021 Oct 30.

Molnupiravir in COVID-19: A systematic review of literature

Awadhesh Kumar Singh  1 , Akriti Singh  2 , Ritu Singh  3 , Anoop Misra  4
Affiliations

Molnupiravir in COVID-19: A systematic review of literature

Awadhesh Kumar Singh et al. Diabetes Metab Syndr. 2021 Nov-Dec.

Abstract

Background and aims: Molnupiravir is a newer oral antiviral drug that has recently been tested in COVID-19. We aim to conduct a systematic review of literature to find out the efficacy and safety of molnupiravir in patients with COVID-19.

Methods: We systematically searched the electronic database of PubMed, MedRxiv and Google Scholar from inception until October 15, 2021, using MeSH keywords. Ongoing trials of molnupiravir in COVID-19 were additionally searched from the ClinicalTrials.Gov and ctri.nic.in/Clinicaltrials. We retrieved all the available granular details of phase 1 to 3 studies of molnupiravir in COVID-19. Subsequently we reviewed the results narratively.

Results: Two phase 1 double-blind, randomized, placebo-controlled (DBRPC) studies of molnupiravir showed that 1600 mg daily dose is safe and tolerable, without any serious adverse events up to 5.5 days. One phase 2 DBPRC study found significantly lower time to clearance (RNA negativity) with molnupiravir 800 mg twice daily compared to the placebo (log-rank p value = 0.013) in mild to moderate COVID-19. Interim report of one phase 3 DBRPC study in non-hospitalized COVID-19 found a significant reduction in the risk of hospital admission or death by 50% (p = 0.0012). However, no significant benefit was observed with molnupiravir in the later stage of moderate to severe COVID-19.

Conclusion: Molnupiravir is first oral antiviral drug to demonstrate a significant benefit in reducing hospitalization or death in mild COVID-19 and could be an important weapon in the battle against SARS-CoV-2. However, its role in moderate to severe COVID-19 is questionable and more studies are needed.

Keywords: COVID-19; EIDD-2801; MK-4482; Molnupiravir; SARS-CoV-2.

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Conflict of interest statement

Declaration of competing interest Nothing to declare for all authors.

Figures

Fig. 1
Fig. 1
Mechanism of action (schematic representation) of molnupiravir against SARS-CoV-2 (works by inducing mutagenesis in viral RNA) as compared with remdesivir (works by stalling RdRp in turn causing chain termination of newly formed RNA strand) and favipiravir (works by slowing/stalling RdRp causing chain termination or inducing mutagenesis or both).
See this image and copyright information in PMC

References

    1. Cannalire R, Cerchia C, Beccari AR, et al. Targeting SARS-CoV-2 proteases and polymerase for COVID-19 treatment: state of the art and future opportunities. J Med Chem. DOI: 10.1021/acs.jmedchem.0c01140. - PMC - PubMed
    1. Subissi L., Posthuma C.C., Collet A. One severe acute respiratory syndrome coronavirus protein complex integrates processive RNA polymerase and exonuclease activities. Proc Natl Acad Sci U S A. 2014 Sep 16;111(37):E3900–E3909. - PMC - PubMed
    1. Crotty S., Cameron C.E., Andino R. RNA virus error catastrophe: direct molecular test by using ribavirin. Proc Natl Acad Sci USA. 2001;98:6895–6900. - PMC - PubMed
    1. Agostini M.L., et al. Small-molecule antiviral β-d-N4-hydroxycytidine inhibits a proofreading-intact coronavirus with a high genetic barrier to resistance. J Virol. 2019;93:24. - PMC - PubMed
    1. Toots M., Yoon J.-J., Hart M., Natchus M.G., Painter G.R., Plemper R.K. Quantitative efficacy paradigms of the influenza clinical drug candidate EIDD-2801 in the ferret model. Transl Res. 2020;218:16–28. - PMC - PubMed

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