Molnupiravir in the treatment of patients with influenza or acute respiratory viral infections: a multicenter comparative randomized double-blind placebo-controlled trial
Abstract
The aim. To evaluate the efficacy and safety of molnupiravir compared to placebo in patients with influenza and/or ARVI.Materials and methods. The study involved 300 patients. The study included patients aged 18 to 80 years with clinical signs of influenza/ARVI (duration no more than 48 hours): elevated body temperature ≥37.5℃ and the presence of at least 2 symptoms of moderate severity (chills, headache, myalgia, sore throat, nasal congestion, runny nose, sneezing, cough, with laboratory-confirmed diagnosis of influenza/ARVI at the time of screening), meeting the selection criteria for the study. Group 1 (n=150) received the investigational medicine molnupiravir (Esperavir®, Promomed Rus LLC, Russia) 800 mg (4 capsules) 2 times/day (daily dose 1600 mg) for 5 days; Group 2 (n=150) received placebo 4 capsules 2 times/day for 5 days, then patient observation was carried out until day 14 (4 visits after screening). The effectiveness of therapy was assessed according to primary and secondary efficacy criteria. The primary efficacy criterion was the time (in days) to clinical recovery. Safety was assessed by considering the number and severity of adverse events (AEs) and serious adverse events (SAEs). For the analysis of qualitative indicators, an intergroup comparison of proportions was performed using a two-sided version of Fisher's exact test, or the χ2 ("chi-square") test. For quantitative indicators — using the non-parametric Mann-Whitney test. Differences were considered…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 300 participants or records.
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