All patients in phase 3 of the study were randomized and given molnupiravir or placebo within 5 days of symptom onset.
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To assess signs and symptoms directly from the patient’s perspective, this new analysis details self-reported symptoms evaluated as key secondary efficacy endpoints from the previous study.
Eligible participants were required to have at least one symptom attributable to COVID-19 at randomization. Participants completed a 15-item daily symptom diary from Day 1 (randomization) until Day 29, rating the severity of each symptom as: ‘none’, ‘mild’, ‘moderate’, or ‘severe’ (except for the loss of smell and loss of taste, rated as ‘yes’ or ‘no’).
For each symptom, time to sustained improvement/resolution was defined as the number of days from randomization to the first of three consecutive days of reduced severity (without subsequent relapse by Day 29).
Time to progression was defined as the number of days from randomization to the first of two consecutive days of worsening severity, compared with baseline.
The ‘modified intention-to-treat analysis population (defined as randomized participants who received at least one dose of treatment and were not hospitalized before the first dose) included 709 participants in the molnupiravir group and 699 in the placebo group.
The diary completion rate was high: above 97% on Day 5 (end of treatment) and above 92% on Day 29 for any symptom in both treatment arms.
When evaluating distinctive COVID-19 symptoms commonly associated with the disease including shortness of breath or difficulty breathing, cough, fatigue (tiredness), loss of smell, and loss of taste, participants in the molnupiravir group were more likely to achieve sustained improvement/resolution by Day 3, Day 5 (end of treatment), and Day 10.
This study supports the treatment benefits of molnupiravir for non-hospitalized patients with COVID-19 in the early stages of their symptoms.
Source: Medindia
