MOVe-OUT (original research)
Trial question
What is the role of early treatment with molnupiravir in unvaccinated adults 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 adult patients with mild-to-moderate, laboratory-confirmed COVID-19 and at least one risk factor for severe COVID-19 illness.
Key exclusion criteria: anticipated need for hospitalization for COVID-19 within 48 hours, dialysis, pregnancy, severe neutropenia, platelet count < 100,000/mL.
Interventions
N=709 molnupiravir (800 mg administered PO BID for 5 days).
N=699 placebo (matching placebo administered PO BID for 5 days).
Primary outcome
Hospitalization or death at day 29
6.8%
9.7%
9.7 %
7.3 %
4.8 %
2.4 %
0.0 %
Molnupiravir
Placebo
Significant
decrease ▼
NNT = 34
Significant decrease in hospitalization or death at day 29 (6.8% vs. 9.7%; ARD -3, 95% CI -5.9 to -0.1).
Secondary outcomes
Significant decrease in hospitalization or death at day 29, interim analysis (7.3% vs. 14.1%; ARD -6.8, 95% CI -11.3 to -2.4).
Significant decrease in all-cause mortality at day 29 (0.1% vs. 1.3%; RR 0.11, 95% CI 0.01 to 0.86).
Borderline significant decrease in COVID-19 related hospitalization or death at day 29 (6.3% vs. 9.2%; ARD -2.8, 95% CI -5.7 to 0).
Safety outcomes
No significant difference in adverse events.
Conclusion
In nonhospitalized, unvaccinated adult patients with mild-to-moderate, laboratory-confirmed COVID-19 and at least one risk factor for severe COVID-19 illness, molnupiravir was superior to placebo with respect to hospitalization or death at day 29.
Reference
Angélica Jayk Bernal, Monica M Gomes da Silva, Dany B Musungaie et al. Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients. N Engl J Med. 2022 Feb 10;386(6):509-520.
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