REMAP-CAP (lopinavir/ritonavir plus hydroxychloroquine), 2020 NCT02735707
Lopinavir/ritonavir plus hydroxychloroquine (n=29) vs. standard of care (n=377)
randomized controlled trial
some concerns about risk of bias
Lopinavir/ritonavir plus hydroxychloroquine.
400 mg of lopinavir and 100 mg of ritonavir every 12h for 5 days minimum, up to a maximum of 14 days or until ICU discharge whichever occurred first. Hydroxychloroquine was administered as two loading doses of 800 mg, 6-h apart, followed 6 h later by 400 mg 12 hourly for 12 doses.
Standard of care
No antiviral treatment.
COVID-19 severe or critically
≥18 years old, admitted with suspected or confrmed COVID-19, and were receiving respiratory or cardiovascular organ failure support in an intensive care unit (ICU). Organ support included the provision of invasive mechanical ventilation, noninvasive mechanical ventilation, high-fow nasal cannulae with a fow rate of at least 30 L per minute and a fractionalinspired oxygen concentration of 0.4 or higher, or the infusion of vasopressor or inotropes for shock.
Open-label.
99 sites across 8 countries.
In the register PE was: all-cause mortality (day 90); days alive and not receiving organ support in ICU (day 21).