2020 - In COVID-19, adding lopinavir–ritonavir to usual care did not shorten time to clinical improvement

Question

In adults hospitalized with coronavirus disease 2019 (COVID-19), what are the efficacy and safety of adding oral lopinavir–ritonavir to usual care?

Design

Randomized controlled trial (RCT) (Lopinavir Trial for Suppression of SARS-CoV-2 in China [LOTUS China] trial).

Blinding

Treatment allocation concealed; unblinded.*

Setting

Jin Yin-Tan Hospital, Wuhan, Hubei Province, China.

Patients

199 patients ≥ 18 years of age (median age 58 y, 60% men, median 13 d from symptom onset to randomization) who had a respiratory tract sample with a reverse transcriptase polymerase chain reaction assay positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)infection, pneumonia confirmed with chest imaging, and oxygen saturation ≤ 94% when breathing ambient air or a ratio of Pao₂:Fio₂ ≤ 300 mg Hg. Key exclusions: severe liver disease, HIV infection, or pregnancy or breastfeeding.

Interventions

Oral lopinavir–ritonavir, 400 mg/100 mg twice daily, plus usual care, which could include ventilation, supplemental oxygen, extracorporeal membrane oxygenation, vasopressor support, antibiotics, and renal replacement therapy (n = 99), or usual care alone (n = 100), for 14 days.

Funding

Major Projects of National Science and Technology on New Drug Creation and Development; Chinese Academy of Medical Sciences Emergency Project of Covid-19; National Science Grant for Distinguished Young Scholars.

* See Glossary.

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Bottom line:

In adults hospitalized with COVID-19, adding oral lopinavir–ritonavir to usual care did not shorten time to clinical improvement.