The US FDA granted Merck’s oral antiviral drug molnupiravir emergency use authorization (EUA): treatment of high-risk mild to moderate COVID-19 patients!

In terms of medication,Molnupiravir should be administered as soon as COVID-19 is diagnosed and within 5 days after the onset of symptoms. The recommended dose is 800mg (4 200mg capsules), orally once every 12 hours for 5 consecutive days. It can be taken with or without food. Completing a complete 5-day course of treatment is very important to eliminate the virus as much as possible and reduce the spread of SARS-CoV-2.

It needs to be pointed out thatMolnupiravir is not recommended for pregnant patients. According to the results of animal reproduction studies, molnupiravir may cause harm to the fetus when administered to pregnant animals.

An analysis of all randomized patients (n=1433) showed:Compared with placebo, molnupiravir reduces the risk of hospitalization or death: 9.7% (n=68/699) of patients in the placebo group were hospitalized or died, compared with 6.8% (n=48/709) in the molnupiravir treatment group, and the absolute risk reduction was 3.0% (95% CI: 0.1, 5.9). Nine deaths were reported in the placebo group and one in the molnupiravir treatment group.

The determination of the main efficacy is based on a planned interim analysis of 762 patients. In the interim analysis, by day 29, molnupiravir treatment significantly reduced the risk of hospitalization or death by 50% compared with placebo: 14.1% (n=53/377) of patients in the placebo group were hospitalized or died, and molnupiravir treatment The group was 7.3% (n=28/385), and the absolute risk reduction was 6.8% (95% CI: 2.4, 11.3; p=0.0024).

The chemical structure of molnupiravir (picture source: scinexx.de)

Molnupiravir is a potent ribonucleoside analog for oral administration, which can inhibit the replication of a variety of RNA viruses, Including the new coronavirus (SARS-CoV-2), which is the pathogen that causes COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prevention, treatment, and prevention of transmission, and has also shown activity in preclinical models of SARS-CoV-1 and MERS.

MOVe-OUT (MK-4482-002; NCT04575597) is a global phase 2/3, randomized, placebo-controlled, double-blind, multi-site study. The subjects are included in the laboratory test confirmed as mild to moderate COVID -19 non-hospitalized adult patients (age ≥18 years) who have not received the SARS-CoV-2 vaccine, have at least one risk factor related to adverse disease outcome, and have symptoms within 5 days before randomization.

The phase 3 part of the trial was carried out globally. Patients were randomly divided into 2 groups at a 1:1 ratio, twice a day, orally molnupiravir (800mg) or placebo for 5 days. The main efficacy goal is to evaluate the efficacy of molnupiravir and placebo by the percentage of patients who were hospitalized and/or died from randomization to day 29.