- Lopinavir-ritonavir monotherapy appears to confer no clinical benefit vs standard care for treatment of patients admitted to the hospital for COVID-19.
Why this matters
- Editorial: This second open-label study confirms findings of an earlier open-label trial, which together indicate "that lopinavir-ritonavir is not effective in improving outcomes for patients admitted to hospital with COVID-19."
- Intent to treat: 5040 patients (1616 lopinavir-ritonavir, 3424 usual care).
- Mean age: 66.2 (standard deviation, 15.9) years.
- 87% of patients receiving lopinavir-ritonavir who completed follow-up received >1 dose.
- Median treatment duration: 5 (interquartile range [IQR], 2-8) days.
- 28-day mortality:
- 23% lopinavir-ritonavir vs 22% usual care.
- Rate ratio (RR): 1.03 (P=.60).
- 28-day mortality in post-hoc analysis of 4423 patients with positive SARS-CoV-2 test, lopinavir-ritonavir vs usual care:
- RR: 1.05 (P=.49).
- Time to discharge for both groups: median, 11 (IQR, 5 to >28) days.
- Discharge alive
- RR: 0.98 (P=.53).
- Progression to invasive mechanical ventilation or death, lopinavir-ritonavir vs usual care:
- RR: 1.09 (P=.092).
- Randomized, controlled, open-label platform trial (RECOVERY) assessing outcomes with lopinavir-ritonavir in UK patients hospitalized with COVID-19.
- Primary outcome: 28-day all-cause mortality.
- Funding: Medical Research Council; National Institute for Health Research.
- Uncollected data (adverse reactions, discontinuations, physiological/laboratory/virological parameters).
- Limited numbers of intubated patients.