Hours after Gilead announced positive results from an NIH trial testing their antiviral drug remdesivir in Covid-19 patients, Anthony Fauci sat on a couch in the Oval Office and gave the world a top-line readout.
Fauci said the drug showed a ?31% improvement,? on the primary endpoint of time to recovery: 11 days in the drug arm compared to 15 days in the placebo arm. He said patients taking the drug were less likely to die, with an 8% mortality rate in the drug arm compared to an 11% on placebo.
The mortality were not yet statistically significant, he said, but were trending in the right direction. Fauci, surrounded by President Trump, Vice President Mike Pence and several other advisors, said it was a ?very optimistic? sign in the search for treatments against Covid-19.
?Although a 31% improvement doesn?t seem like? a knockout 100%, it is a very important proof of concept,? he said. ?Because what it has proven, is that a drug has blocked this virus.?
Fauci said more details would come ? NIAID indicated this morning that the data would be unveiled at a White House press briefing, likely at 5 pm ? and that the study would be submitted to a peer review journal. ?Trump, who deferred to Fauci in giving the readout, then praised the results.
?But certainly it?s a, it?s a positive it?s a very positive event,? Trump said.
The data is the largest randomized controlled study for remdesivir in Covid-19 patients and has been long awaited by doctors and public health officials. But it comes on the same morning as readouts from two other studies, including another placebo-controlled trial published in?The Lancet?this morning that concluded that the drug had no effect on severe Covid-19 patients.
That trial, which took place in China but was never fully completed after the epidemic came under control there, was reported on last week after a preprint abstract briefly appeared on the World Health Organization website. The full peer-reviewed results concluded that ?Remdesivir use was not associated with a difference in time to clinical improvement.? There was a numerical ? but not statistically significant ? improvement in one subset of patients.
Unlike the Chinese trial, the NIH study also included moderate patients. Virologists have suggested that the drug is likely to work best the earlier it is given.
Former FDA chief Scott Gottlieb said this morning, before full data were publicly available, that the trial results were likely enough to secure an emergency FDA approval.
The adaptive trial design employed by the NIH calls for the study to continue after a drug is found effective, with that drug becoming the control and a new arm enrolled with an experimental compound.