Review
Molnupiravir in COVID-19: A systematic review of literature

https://doi.org/10.1016/j.dsx.2021.102329Get rights and content

Highlights

  • Molnupiravir is an oral antiviral drug that works through the mechanism of error catastrophe against SARS-CoV-2.

  • Phase 1 studies in humans showed molnupiravir safe and tolerable.

  • Phase 2/3 studies showed molnupiravir effectiveness in mild COVID-19.

  • However, molnupiravir did not work in late moderate to severe COVID-19.

  • Several phase 3 Indian studies of molnupiravir are ongoing in both mild and moderate COVID-19.

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

Molnupiravir
EIDD-2801
MK-4482
COVID-19
SARS-CoV-2

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