Introduction
death, coronavirus disease 2019
CORONAVIRUS DISEASE 2019, ADVERSE EVENTS, DISEASE, MAY, CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME
Immunocompromised individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are more likely to progress to severe coronavirus disease 2019 (COVID-19) and have poor outcomes [Molnupiravir is an oral, small-molecule ribonucleoside prodrug of β-D-N4-hydroxycytidine (NHC) which has potent activity against SARS-CoV-2, including all variants of concern to date [MOVe-OUT was a phase 2/3 randomized, double-blind, placebo-controlled trial that evaluated molnupiravir for the treatment of non-hospitalized adults with mild-to-moderate COVID-19 and risk factors for progression to severe disease. In the interim analysis for the phase 3 component of MOVe-OUT (enrollment May 6 through August 5, 2021), molnupiravir was superior to placebo in reducing the risk for all-cause hospitalization or death by Day 29 (7.3% vs. 14.1%; difference,  – 6.8%; 95% CI,  – 11.3 to  – 2.4). In the final analysis including all randomized participants (enrollment May 6 through October 2, 2021), molnupiravir demonstrated a reduction in the risk for all-cause hospitalization or death (6.8% vs. 9.7%; difference,  – 3.0%; 95% CI,  – 5.9 to  – 0.1), with an 89% relative risk reduction in all-cause mortality compared with placebo [This post hoc analysis explored virologic data, as well as clinical efficacy and safety, in the cohort of immunocompromised participants from the phase 3 component of MOVe-OUT. We compared all-cause hospitalization or death and adverse events along with SARS-CoV-2 viral RNA, viral infectivity, viral RNA nucleotide error rate, treatment-emergent amino acid changes, and anti-SARS-CoV-2 antibody status among immunocompromised and non-immunocompromised participants treated with molnupiravir versus placebo.