Treatment with molnupiravir reduced the risk of an acute care visit in nonhospitalized adults with mild to moderate COVID-19 who were at high risk for progressing to severe disease, according to new data from the phase 3 MOVe-OUT trial.   

Molnupiravir is a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis. The placebo-controlled, double-blind MOVe-OUT trial (ClinicalTrials.gov Identifier: NCT04575597) included adults with mild to moderate COVID-19 with symptom onset within 5 days of randomization.

Study participants were required to have at least 1 risk factor associated with poor disease outcomes. The modified intent-to-treat (MITT) population included all participants who were randomly assigned, received at least 1 dose of molnupiravir, and were not hospitalized before the first dose.


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Analyses of prespecified exploratory endpoints in the MITT population showed that 7.2% of patients treated with molnupiravir reported an acute care visit through day 29 vs 10.6% of patients treated with placebo, corresponding to a relative risk reduction (RRR) of 32.1% (95% CI, 4.4-51.7). Findings also demonstrated that a lower proportion of molnupiravir-treated patients had a COVID-19-related acute care visit compared with patients who received placebo (6.6% vs 10.0%; RRR, 33.8% [95% CI, 5.6-53.6]).

Additionally, a post hoc analysis of the trial showed that fewer patients in the molnupiravir arm required respiratory interventions (including conventional oxygen therapy, a high-flow heated and humidified device, noninvasive mechanical ventilation, or invasive mechanical ventilation) compared with the placebo arm (RRR, 34.3% [95% CI, 4.3-54.9] for all respiratory interventions). Treatment with molnupiravir also resulted in larger reductions in mean C-reactive protein and earlier and larger improvements in mean change from baseline oxygen saturation values.

In a subgroup of patients who were hospitalized after randomization, post hoc analyses showed that the median time to hospital discharge was 9 days (95% CI, 7-12) for patients treated with molnupiravir and 12 days (95% CI, 9-14) for patients in the placebo group. Moreover, fewer patients in the molnupiravir arm required respiratory interventions compared with the placebo arm (RRR, 21.3% [95% CI, 0.2-38.0]).

“The primary data from MOVe-OUT demonstrated a significant reduction in the risk for progression to severe COVID-19, including hospitalization and death, when compared to placebo among nonhospitalized, at-risk patients. In light of the continued burden of COVID-19, we are encouraged by these new data,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics. 

Molnupiravir is currently authorized for emergency use for the treatment of mild to moderate COVID-19 in adults 18 years of age and older with positive results of direct SARS-CoV-2 viral testing and who are at risk for progressing to severe COVID-19 and/or hospitalization, and for whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate. The trade name for molnupiravir in the US is Lagevrio.

Reference

Merck and Ridgeback announce new data for investigational Lagevrio™ (molnupiravir) from phase 3 MOVe-OUT study. News release. Merck. Accessed June 7, 2022. https://www.merck.com/news/merck-and-ridgeback-announce-new-data-for-investigational-lagevrio-molnupiravir-from-phase-3-move-out-study/

This article originally appeared on MPR