ETIOTROPIC THERAPY OF MILD COVID-19 IN OUTPATIENT PATIENTS: MOLNUPIRAVIR IS IN FOCUS

Abstract

The aim of the study was to evaluate the efficacy and tolerability of the drug Molnupiravir in adult outpatients with mild Covid–19. Materials and methods. A randomized comparative open clinical trial of Molnupiravir (800 mg twice daily for 5 days in addition to symptomatic/pathogenetic therapy) was conducted in confirmed COVID-19 in comparison with a standard therapy. 240 patients (average age – 43.5 years; 70% had risk factors) were randomized in a 1:1 ratio to the Molnupiravir group and the standard therapy group. Clinical efficacy was assessed based on the analysis of the patient's daily diary, physical examination data and SARS-CoV-2 RNA in the smear from the oropharynx and nasopharynx. The primary endpoint was the proportion of patients with the transition of COVID-19 course to a more severe degree relative to the initial state 2 weeks after the onset of the disease. Significance was assessed using a two-sided version of the Fisher Exact test. Results. Molnupiravir: a) reduced the risk of disease progression by 4 times by the 14th –15th day of follow-up, compared with the risk in the control group (2.5% and 10% of patients, respectively, p = 0.0149); b) accelerated virus elimination by the 6th – 7th day of follow-up (71.67% vs. 58.33%, respectively); c) accelerated clinical recovery (which by day 6-7 had 19% of patients in the Molnupiravir group, and 6% of patients on standard therapy); d) reduced the frequency and severity of COVID-19 symptoms: cough, ageusia. The incidence of adverse events in the study participants was comparable. Conclusions. Molnupiravir administration reduces the risk of COVID-19 progression to a severe course, reduces the severity of COVID-19 clinical manifestations, probably by accelerating the virus elimination. The data obtained indicate feasibility of using Molnupiravir for COVID-19 treatment on an outpatient basis.