RECOVERY (nirmatrelvir/ritonavir)
Trial question
What is the role of nirmatrelvir/ritonavir in patients hospitalized with COVID-19?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 137
137 patients (60 female, 77 male).
Inclusion criteria: patients hospitalized with COVID-19.
Key exclusion criteria: first trimester of pregnancy; severe liver impairment; severe renal impairment; receipt of nirmatrelvir/ritonavir during current illness; receipt of a concomitant medication with CYP3A4 dependent metabolism risking a severe drug-drug interaction.
Interventions
N=68 nirmatrelvir/ritonavir (at a dose of 300 mg/100 mg PO BID for 5 days plus standard of care).
N=69 usual care (standard of care only).
Primary outcome
Death at day 28
19%
19%
19.0 %
14.3 %
9.5 %
4.8 %
0.0 %
Nirmatrelvir/ritonavir
Usual
care
No significant
difference ↔
No significant difference in death at day 28 (19% vs. 19%; HR 1.02, 95% CI 0.47 to 2.23).
Secondary outcomes
No significant difference in the rate of discharged alive within 28 days (71% vs. 78%; RR 0.8, 95% CI 0.54 to 1.2).
No significant difference in invasive mechanical ventilation or death (21% vs. 19%; RR 1.06, 95% CI 0.54 to 2.08).
No significant difference in receipt of ventilation (8% vs. 17%; RR 0.56, 95% CI 0.18 to 1.33).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients hospitalized with COVID-19, nirmatrelvir/ritonavir 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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