The authors conducted a randomised, controlled, open-label trial of hospitalised adult patients with confirmed COVID-19 and an oxygen saturation (Sao2) of ≤94% on air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) <300 mm Hg. Patients were randomised (1:1) to receive either lopinavir-ritonavir (400 mg and 100 mg, respectively) BD for 14 days, in addition to standard care, or standard care alone. The primary endpoint was the time to clinical improvement (randomisation to either an improvement of two points on a seven-category ordinal scale or discharge from hospital). 199 patients with laboratory-confirmed SARS-CoV-2 infection were randomised: 99 to the lopinavir-ritonavir group and 100 to the standard-care group. The authors found that treatment with lopinavir-ritonavir was not associated with a difference compared with standard care in the time to clinical improvement. Mortality at 28 days was similar in the lopinavir-ritonavir group and the standard-care group (19.2% vs. 25.0%). The percentages of patients with detectable viral RNA at various timepoints were also similar. In a modified intention-to-treat analysis, lopinavir-ritonavir was found to lead to a median time to clinical improvement that was 1 day shorter than with standard care (hazard ratio 1.39, 95%CI 1.00–1.91). Gastrointestinal adverse events were more common in the lopinavir-ritonavir group, but serious adverse events were more common in the standard-care group. Lopinavir-ritonavir treatment was stopped early in 13.8% patients due to adverse events. Therefore in hospitalised adult patients with severe COVID-19 there was no benefit with lopinavir-ritonavir treatment beyond standard care.
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