Lopinavir-ritonavir offers no survival benefit in adults hospitalized with severe COVID-19

  • Cao B & al.
  • N Engl J Med
  • 18 Mar 2020

  • curated by Liz Scherer
  • Clinical Essentials
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Takeaway

  • 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.

Key results

  • 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.

Study design

  • 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.

Limitations

  • Open-label.
  • Missing confounders.