RECOVERY (molnupiravir)
Trial question
What is the role of molnupiravir in patients hospitalized with COVID-19?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 923
923 patients (376 female, 547 male).
Inclusion criteria: patients hospitalized with COVID-19.
Key exclusion criteria: pregnancy or lactation; receipt of molnupiravir during current illness.
Interventions
N=445 molnupiravir (at a dose of 800 mg PO BID for 5 days plus standard of care).
N=478 usual care (standard of care only).
Primary outcome
Death at day 28
17%
17%
17.0 %
12.8 %
8.5 %
4.3 %
0.0 %
Molnupiravir
Usual
care
No significant
difference ↔
No significant difference in death at day 28 (17% vs. 17%; HR 0.93, 95% CI 0.68 to 1.28).
Secondary outcomes
No significant difference in the rate of discharged alive within 28 days (72% vs. 74%; RR 0.96, 96% CI 0.82 to 1.12).
No significant difference in invasive mechanical ventilation or death (17% vs. 17%; RR 0.96, 96% CI 0.73 to 1.25).
No significant difference in receipt of ventilation (11% vs. 8%; RR 1.24, 95% CI 0.8 to 1.9).
Safety outcomes
No significant differences in new cardiac arrhythmia, thrombotic events, clinically significant bleeding, non-coronavirus infections, seizures, acute liver injury, and AKI.
Significant difference in hyperglycemia requiring insulin (7.4% vs. 3.1%).
Conclusion
In patients hospitalized with COVID-19, molnupiravir was not superior to usual care with respect to death at day 28.
Reference
RECOVERY Collaborative Group, Peter W Horby, Natalie Staplin et al. Molnupiravir or nirmatrelvir-ritonavir versus usual care in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. medRxiv. 2024 May 24.
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