Molnupiravir in COVID-19: A systematic review of literature

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

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.

Publication types

  • Systematic Review

MeSH terms

  • Antiviral Agents / therapeutic use*
  • COVID-19 / virology
  • COVID-19 Drug Treatment*
  • Cytidine / analogs & derivatives*
  • Cytidine / therapeutic use
  • Hospitalization / statistics & numerical data*
  • Humans
  • Hydroxylamines / therapeutic use*
  • SARS-CoV-2 / drug effects*

Substances

  • Antiviral Agents
  • Hydroxylamines
  • Cytidine
  • molnupiravir