A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19.

Abstract (PubMed)

Randomized, controlled, open-label trial (LOTUS China) in hospitalized adults with confirmed SARS-CoV-2 (SaO2 ≤94% or PaO2/FiO2 ≤300 mmHg), Jan 18 – Feb 3, 2020, Jin Yin-Tan Hospital, Wuhan. Randomly assigned 1:1 to lopinavir-ritonavir (400/100 mg twice daily × 14d) plus standard care vs standard care alone. Primary endpoint: time to clinical improvement (≥2-point improvement on 7-point ordinal scale or discharge). 199 patients randomized (99 LPV/r, 100 standard care). Primary endpoint: HR 1.24 (95% CI 0.90–1.72), NS. 28-day mortality: 19.2% vs 25.0% (difference -5.8%; 95% CI -17.3 to 5.7). GI adverse events more common in LPV/r; serious adverse events more common in standard care. No benefit observed beyond standard care.