NIH’s National Institute of Allergy and Infectious Disease has released preliminary data showing the study meeting the primary outcome of statistical improvement in time to recovery by day 29; patients who were treated showed a median time to recovery of 22 days compared to 15 days for those receiving placebo. Additional data will be released while the study with results is being submitted for publication in a peer reviewed journal.
“Although a 31% improvement doesn’t seem like a knockout 100%, it is a very important proof of concept. What it has proven is that a drug can block this virus,” NIAID Director Anthony S. Fauci, MD, said today during an appearance with President Donald Trump. “This will be the standard of care.” To which the president added, “It’s a beginning. That means you build on it. But it’s a very positive event.”
This is the first clinical study launched in America of a possible therapeutic for the COVID-19 virus. Remdesivir is among 18 other candidates that are designated as being the front runners among over 160 other possible therapeutics that are under study that can be viewed in GEN updated A-List by clicking here.
Remdesivir had a mortality rate of 8% compared to 11% of those receiving placebo, the agency suggests that this is a survival benefit to the nucleotide prodrug. This trial (ACCTT; NCT04280705) is an adaptive, randomized, double blind, placebo controlled trial evaluating 1,063 hospitalized COVID-19 patients with a broad range of symptoms; and is one of three randomized blinded Phase III studies assessing the drug candidate involving a total of 68 sites (47 in America and 21 in Europe and Asia).
“Based upon their review of the data, they noted that remdesivir was better than placebo from the perspective of the primary endpoint, time to recovery,” NIAID stated. “Recovery in this study was defined as being well enough for hospital discharge or returning to normal activity level.”
“Accumulating data on Remdesivir suggests it’s active against COVID and there’s now enough data to support consideration of access under an emergency use authorization by FDA. The data from NIAID study should push this firmly over the line,” writes Scott Gottlieb, MD, former FDA Commissioner.
However, not everyone is as excited including Eric Topol, MD, who is the director of the Scripps Research Translational Institute who cautions “The new remdesivir data from Tony Fauci from N >1,000 placebo-controlled trial (unpublished, Oval Office citation) does not show statistically significant reduction in mortality (8% vs 11%, in the right direction) but a clear-cut benefit in time to recovery 11 vs 15 days, P<0.001.”
This was just one of the two remdesivir studies that data was released for, as the Lancet published results showing that the drug candidate failed to show clinical improvements in severely infected patients in a Chinese Phase III trial (NCT04257656); this trial was a randomised, double blinded, placebo controlled multicenter trial in which remdesivir failed to reduce the presence of the virus in the bloodstream of 158 patients who were treated with the candidate in the 237 patient trial.
Primary endpoint in this trial was time to clinical improvement up to day 28, the average time to clinical improvement was 21 days for those treated and 23 for those receiving placebo. 28 days after treatment 13.9% of those in the remdesivir cohort died compared to 12.8% of the placebo group. Of the secondary outcomes 11.3% in the treatment group died within 10 days of illness onset compared to 14.9% of the placebo group.11.6% of the treatment group were taken off of the drug candidate due to side effects compared to 5.1% of the placebo group; adverse effects were reported from 65.8% of the remdesivir group compared to 64.1% of the placebo group.
University of Chicago, which is one of the treatment sites cautions, “Drawing any conclusions at this point is premature and scientifically unsound.”
