Molnupiravir for the treatment of COVID-19 in immunocompromised participants: efficacy, safety, and virology results from the phase 3 randomized, placebo-controlled MOVe-OUT trial

Matthew G. Johnson, Julie M. Strizki, Michelle L. Brown, Hong Wan, Hala H. Shamsuddin, Moti Ramgopal, Diana F. Florescu, Pierre Delobel, Ilsiyar Khaertynova, José F. Flores, Leon F. Fouche, Shan Chwen Chang, Angela Williams-Diaz, Jiejun Du, Jay A. Grobler, Amanda Paschke, Carisa De Anda

Research output: Contribution to journalArticlepeer-review

14 Scopus citations

Abstract

Purpose: Immunocompromised patients have a potentially increased risk for progression to severe COVID-19 and prolonged replication of SARS-CoV-2. This post hoc analysis examined outcomes among immunocompromised participants in the MOVe-OUT trial. Methods: In phase 3 of MOVe-OUT, non-hospitalized at-risk adults with mild-to-moderate COVID-19 were randomized to receive molnupiravir 800 mg or placebo twice daily for 5 days. Immunocompromised participants were identified based on prior/concomitant medications and/or medical history. All-cause hospitalization/death, adverse events, SARS-CoV-2 titers, infectivity, and RNA sequences were compared between immunocompromised participants who received molnupiravir or placebo and with non-immunocompromised participants. Results: Fifty-five of 1408 participants were considered immunocompromised. Compared to placebo, fewer molnupiravir-treated immunocompromised participants were hospitalized/died through Day 29 (22.6% [7/31] vs. 8.3% [2/24]), with fewer adverse events (45.2% [14/31] vs. 25.0% [6/24]). A larger mean change from baseline in SARS-CoV-2 RNA was observed with molnupiravir compared to placebo in non-immunocompromised participants (least squares mean [LSM] difference Day 5: – 0.31, 95% confidence interval [CI] – 0.47 to – 0.15), while the mean change was comparable between treatment groups in immunocompromised participants (LSM difference Day 5: 0.23, 95% CI – 0.71 to 1.17). Molnupiravir treatment was associated with increased clearance of infectious virus. Increased errors in viral nucleotide sequences in post-baseline samples compared to placebo support molnupiravir’s mechanism of action and were not associated with observation of novel treatment-emergent amino acid substitutions in immunocompromised participants. Conclusion: Although the study population was small, these data suggest that molnupiravir treatment for mild-to-moderate COVID-19 in non-hospitalized immunocompromised adults is efficacious and safe and quickly reduces infectious SARS-CoV-2. ClinicalTrials.gov Registration Number: NCT04575597.

Original languageEnglish (US)
Pages (from-to)1273-1284
Number of pages12
JournalInfection
Volume51
Issue number5
DOIs
StatePublished - Oct 2023

Keywords

  • COVID-19
  • Immunocompromised
  • Molnupiravir
  • Treatment
  • Virology

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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