MOVe-OUT (patient-reported symptom outcomes)
Trial question
What is the role of molnupiravir in at-risk, unvaccinated patients with COVID-19?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
51.0% female
49.0% male
N = 1408
1408 patients (723 female, 685 male)
Inclusion criteria: nonhospitalized, unvaccinated, at-risk adults with mild-to-moderate, laboratory-confirmed COVID-19 and symptom onset within 5 days before randomization
Key exclusion criteria: current hospitalization or an expected need for hospitalization due to COVID-19 within 48 hours of randomization; receipt of certain therapies indicated specifically for the treatment of COVID-19 or SARS-CoV-2 vaccination
Interventions
N=709 molnupiravir (oral dose of 800 mg BID for 5 days)
N=699 placebo (matching placebo BID for 5 days)
Primary outcome
Median time to first resolution of symptoms
18
20
20.0 days
15.0 days
10.0 days
5.0 days
0.0 days
Molnupiravir
Placebo
Significant
increase ▲
Significant increase in median time to first resolution of symptoms (18 days vs. 20 days; HR 1.18, 95% CI 1.03 to 1.34)
Secondary outcomes
Significant increase in median time to first alleviation of symptoms (13 days vs. 15 days; HR 1.16, 95% CI 1.03 to 1.32)
Significant increase in median time to alleviation of all symptoms through day 29 (8 days vs. 10 days; HR 1.24, 95% CI 1.09 to 1.4)
Borderline significant increase in median time to sustained alleviation of all symptoms through day 29 (15 days vs. 16 days; HR 1.17, 95% CI 1.02 to 1.33)
Conclusion
In nonhospitalized, unvaccinated, at-risk adults with mild-to-moderate, laboratory-confirmed COVID-19 and symptom onset within 5 days before randomization, molnupiravir was superior to placebo with respect to median time to first resolution of symptoms.
Reference
Yanfen Guan, Amy Puenpatom, Matthew G Johnson et al. Impact of Molnupiravir Treatment on Patient-Reported Coronavirus Disease 2019 (COVID-19) Symptoms in the Phase 3 MOVe-OUT Trial: A Randomized, Placebo-Controlled Trial. Clin Infect Dis. 2023 Nov 30;77(11):1521-1530.
Open reference URL