Is lopinavir-ritonavir effective against severe COVID-19?
Treatment with lopinavir-ritonavir in addition to standard care appears to have no clear benefit in hospitalized adult patients with severe coronavirus disease (COVID-19), reveals a study.
A total of 199 patients with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection were randomly assigned to receive either lopinavir-ritonavir (400 mg and 100 mg, respectively; n=99) twice a day for 14 days, in addition to standard care, or standard care alone (n=100). Time to clinical improvement was the primary endpoint.
Time to clinical improvement was defined as “the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first.”
The primary endpoint was not significantly different between lopinavir-ritonavir and standard care (hazard ratio [HR] for clinical improvement, 1.24, 95 percent confidence interval [CI], 0.90–1.72). Mortality at 28 days was also comparable between the two treatment groups (19.2 percent vs 25.0 percent; difference, –5.8 percent, 95 percent CI, –17.3 to 5.7).
For patients with detectable viral RNA at various time points, the proportion was similar between the lopinavir-ritonavir group and the standard-care group. Patients treated with lopinavir-ritonavir had a median time to clinical improvement that was 1 day shorter than that seen in those receiving standard care (HR, 1.39, 95 percent CI, 1.00–1.91).
Gastrointestinal adverse events occurred more frequently in the lopinavir-ritonavir group, while serious adverse events were more common in the standard-care group. Thirteen patients (13.8 percent) discontinued treatment with lopinavir-ritonavir early due to adverse events.
“Future trials in patients with severe illness may help to confirm or exclude the possibility of a treatment benefit,” the Investigators said.
SARS-CoV-2 causes the respiratory illness COVID-19. It was first detected in Wuhan, China, and eventually spread across the globe due to censorship by Chinese authorities and delayed institution of travel restrictions. Infections worldwide have now breached the 1 million mark, with more than 52,000 deaths, as of this writing.