Clinical Trial Info

Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)

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This Phase 2/3 study aims to evaluate the safety, tolerability, and efficacy of molnupiravir (MK-4482) compared to placebo.

The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29.

This study will enroll approximately 1,850 participants who are 18 years and older and has documentation of laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

Results

Merck and Ridgeback Biotherapeutics announced that data evaluating LAGEVRIO™(molnupiravir), will be presented at the 2022 European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

In 188 participants with infectious virus isolated at baseline and for whom post-baseline infectivity data were available, molnupiravir was associated with more rapid elimination of infectious virus than placebo.

At Day 3 of treatment, among patients with an infectious virus at baseline, infectious SARS-CoV-2 was detected in 0.0% (n=0/92) of patients who received LAGEVRIO, compared with 21.8% (n=20/96) of patients who received placebo.

At Day 5, infectious virus was detected in 0.0% (n=0/91) of patients in the LAGEVRIO arm compared with 2.2% (n=2/89) in the placebo arm.

On Day 10, no infectious virus was detected in either arm for patients with an infectious virus at baseline.

Molnupiravir was also associated with greater mean reductions from baseline in SARS-CoV-2 RNA than placebo from Days 3 through 10, though molnupiravir and placebo were associated with comparable rates of viral RNA clearance through Day 29.