- Lopinavir-ritonavir treatment does not improve survival or time to clinical improvement when added to standard supportive care in severely ill adults hospitalized for COVID-19.
- Data hint at shorter ICU stays with drug combination.
Why this matters
- Supportive care remains first-line.
- Related editorial.
- 199 randomized patients (99 intervention, 100 standard care); median age 58 years, 60.3% men.
- Intent-to-treat: lopinavir-ritonavir did not shorten time to clinical improvement in patients treated:
- >12 days PSO: HR, 1.30 (95% CI, 0.84-1.99).
- Similar between-group time to clinical deterioration: HR, 1.01 (95% CI, 0.76-1.34).
- Similar 28-day mortality:
- 19.2% (19) vs 25.0% (25);
- Difference −5.8% (−17.3 to 5.7).
- Active treatment:
- Shorter ICU stays: 6 vs 11 days standard care;
- Difference: −5 days (95% CI, −9 to 0).
- Greater clinical improvement at day 14:
- 45.5% vs 30% standard care;
- Difference: 15.5 (95% CI, 2.2-28.8).
- Viral RNA loads did not differ over time.
- Active treatment halted in 13.8% (13) patients because of treatment-related adverse events.
- Open-label, randomized controlled trial study evaluating efficacy, safety of oral lopinavir (400 mg)-ritonavir (100 mg) in severely ill adults hospitalized with COVID-19.
- Funding: National Science and Technology on New Drug Creation and Development, China.
- Missing confounders.