6/28/23, 11:01 PM LOTUS China Pathway Feedback Search Clinical Topics Home Studies LOTUS China LOTUS China Disease COVID 19 infection Trial question What is the effect of lopinavir-ritonavir in adults hospitalized with severe COVID-19? Study design Single center Open label RCT Population Characteristics of study participants 40.0% female N = 199 60.0% male 199 patients (79 female, 120 male) Inclusion criteria: hospitalized adult patients with confirmed COVID-19 infection Key exclusion criteria: known allergy or hypersensitivity to lopinavir-ritonavir, known severe liver disease, use of medications that are contraindicated with lopinavir-ritonavir and that could not be replaced or stopped during the trial period, pregnancy or breast-feeding, or known HIV infection Interventions N=99 lopinavir-ritonavir (400 mg and 100 mg twice a day for 14 days plus standard care for 14 days) N=100 standard care (standard care alone for 14 days) Primary outcome https://web.pathway.md/studies/recSVRCSAarMLjD4V 1/2 6/28/23, 11:01 PM LOTUS China Pathway Time to clinical improvement 16.0 days 16 16 12.0 days 8.0 days 4.0 days No significant difference 0.0 days Lopinavir-ritonavir Standard care No significant difference in time to clinical improvement (16 days vs. 16 days; HR 1.31, 95% CI 0.95 to 1.85) Secondary outcomes Borderline significant decrease in length of ICU stay (6 days vs. 11 days; AD -5 days, 95% CI -9 to 0) No significant difference in duration of invasive mechanical ventilation (4 days vs. 5 days; AD -1 days, 95% CI -4 to 2) Safety outcomes No significant difference in adverse events or shock. Significant differences in gastrointestinal adverse events, which were more common in the placebo group - and serious adverse events, which were more common in the standard care group. Conclusion In hospitalized adult patients with confirmed COVID-19 infection, lopinavir-ritonavir was not superior to standard care with respect to time to clinical improvement. Reference Cao B, Wang Y, Wen D et al. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid- 19. N Engl J Med. 2020 May 7;382(19):1787-1799. Open reference URL https://web.pathway.md/studies/recSVRCSAarMLjD4V 2/2