New Data Show Additional Clinical Benefits of COVID-19 Antiviral Molnupiravir

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.

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/