RECOVERY (lopinavir/ritonavir)
Trial question
What is the role of lopinavir/ritonavir in patients admitted to hospital with COVID-19?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 5040
5040 patients (1963 female, 3077 male)
Inclusion criteria: patients admitted to hospital with COVID-19
Key exclusion criteria: severe hepatic insufficiency, using medicinal products that are highly dependent on cytochrome P450 3A4 for clearance and for whom elevated plasma concentrations would be associated with serious or life-threatening events
Interventions
N=1616 lopinavir/ritonavir (400 mg and 100 mg PO BID for 10 days or until discharge)
N=3424 usual care (standard of care)
Primary outcome
Death from all causes at 28 days
23
22
23.0 %
17.3 %
11.5 %
5.8 %
0.0 %
Lopinavir/ritonavir
Usual
care
No significant
difference ↔
No significant difference in death from all causes at 28 days (23% vs. 22%; RR 1.03, 95% CI 0.91 to 1.17)
Secondary outcomes
No significant difference in the rate of discharge from hospital within 28 days (69% vs. 70%; RR 0.98, 95% CI 0.91 to 1.05)
No significant difference in receipt of invasive mechanical ventilation or death (29% vs. 27%; RR 1.09, 95% CI 0.99 to 1.2)
No significant difference in invasive mechanical ventilation (10% vs. 9%; RR 1.15, 95% CI 0.95 to 1.39)
Safety outcomes
No significant difference in cardiac arrhythmias and requirement of renal dialysis or hemofiltration.
Conclusion
In patients admitted to hospital with COVID-19, lopinavir/ritonavir was not superior to usual care with respect to death from all causes at 28 days.
Reference
Peter W Horby, Marion Mafham, Jennifer L Bell et al. Lopinavir-ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet. 2020 Oct 5;396(10259):1345-1352.
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