**Note: the release below is a special early release from the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022, Lisbon, 23-26 April). Please credit the conference if you use this story**
An analysis of patient-reported data on the investigational COVID-19 antiviral drug molnupiravir suggests better outcomes in patients with molnupiravir treatment compared to placebo for most COVID-related symptoms. The analysis, which will be presented at this year’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022, Lisbon, 23-26 April), is led by Yanfen Guan, of the pharmaceutical company MSD, a trade name of Merck & Co., Inc, Kenilworth, NJ, USA, who manufacture molnupiravir (brand name Lagevrio).
Data on the efficacy of molnupiravir in reducing the risk of progression of COVID-19 in non-hospitalised, unvaccinated patients at the highest risk of poor outcomes (the MOVe-OUT study), was published in NEJM in December 2021*. All patients in phase 3 of the study were randomised and given molnupiravir or placebo within 5 days of symptom onset. The drug has been granted an emergency use authorisation by the by the US Food and Drug Administration (FDA) and is also authorised for use in the UK, Australia, and Japan and 12 other jurisdictions.*
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 MOVe-OUT study.
Eligible participants were required to have at least one symptom attributable to COVID-19 at randomisation. Participants completed a 15-item daily symptom diary from Day 1 (randomisation) until Day 29, rating the severity of each symptom as: ‘none’, ‘mild’, ‘moderate’, or ‘severe’ (except 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 randomisation 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 randomisation to the first of two consecutive days of worsening severity, compared with baseline.
The ‘modified intention-to-treat’ analysis population (defined as randomised participants who received at least one dose of treatment and were not hospitalised prior to first dose) included 709 participants in the molnupiravir group and 699 in the placebo group. Diary completion rate was high: above 97% at Day 5 (end of treatment) and above 92% at Day 29 for any symptom in both treatment arms.
For most COVID-19 symptoms, sustained improvement/resolution was more likely in the molnupiravir than the placebo group through Day 29; the observed benefit was greatest for loss of smell and fatigue (see figure 1). Similarly, symptom progression was less likely with molnupiravir (see figure 2). 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 (figure 3).
The authors conclude: “In this study, we observed a positive impact of molnupiravir treatment on the outcome for most patient-reported COVID-19 symptoms compared to placebo, supporting the treatment benefits of molnupiravir for non-hospitaliaed patients with COVID-19 in the early stages of their symptoms.”
All requests for interviews with the study authors should be MSD Media Office Sienna Choi T) +1 908 873 4311 E) firstname.lastname@example.org and Courtney Ronaldo T) +1 (908) 442-5695 E) email@example.com
Alternative contact in the ECCMID Media Centre Tony Kirby of Tony Kirby PR T) +44 7834 385827 E) firstname.lastname@example.org
Conflict of interest statement: Some authors on this study are employees of Merck & Co., Inc., Kenilworth, NJ, USA, the manufacturer of molnupiravir
This press release is based on late breaker abstract L0449 at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) Annual Meeting to be held in Lisbon from 23-26 April. The material has been peer reviewed by the congress selection committee. There is no full paper at this stage, but the authors are happy to answer your questions. The research has not yet been submitted for publication.
**In addition to the USA, the UK, Japan and Australia, molnupiravir is also authorised in Colombia, Mexico, Panama, Peru, Costa Rica, Taiwan, Thailand, South Korea, United Arab Emirates, Bahrain, Ukraine, and Qatar (total 16 jurisdictions)