First major RCT in severe #COVID19 Rx. First: wow! This disease is a few months old, and we have an RCT with ~200 patients. Almost certainly record-setting. @GWR nejm.org/doi/full/10.10…
What did they do? They gave lopinavir-ritonavir (a drug used in HIV infection) to half the patients, and the other half got "usual care". This was "open label", meaning that investigators knew who was getting the lop-rit. Totally understandable in a trial during an outbreak.
Their primary outcome was "time to clinical improvement". They initially planned a trial with 160 patients, decided they needed more, but then halted it because they wanted to try remdesivir (presumably because this drug's performance was disappointing).
60% male; avg. age 58
All required hospitalization, but only ~1% required invasive mechanical ventilation: they were sick, but not THAT sick on entry. But 30% eventually needed mechanical ventilation, and 1 in 5 needed vasopressors. Almost all received antibiotics, and 1/3 were given corticosteroids
The money shot: totally unimpressive. Viral loads (justification for this Rx in theory) also had no difference.
You don't need to be a statistician to see that lopinavir-ritonavir is not something that will change this pandemic. Additionally,~14% had pretty bad GI side effects
The optimists will point out that the median duration in ICU was 6 days shorter in lop-rit are, that mortality was 6% less, and patients got out of hospital 2 days earlier. It is impossible to know how to interpret this in an open-label trial. But there is hope.
We should be grateful for Major Projects of National Science and Technology on New Drug Creation and Development and others for funding this trial, and furthering our understanding of how to treat these patients. For now, Lopinavir-Ritonavir will remain debated for Rx in #COVID19
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