'Breakthrough' COVID-19 Drug Remdesivir Also Has 'No Significant Clinical Benefits'
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and lead member of the Trump Administration's White House Coronavirus Task Force, called a new drug developed by Gilead Science as a treatment for COVID-19 as having a clear-cut, significant, positive effect in diminishing the time to recovery at a press conference on April 29th.
Based on preliminary data from the Adaptive COVID-19 Treatment Trial (ACTT), the Food and Drug Administration (FDA) has been working with Gilead to make the drug available to patients as soon as possible.
But another study released the same day as the announcement and published in The Lancet said the speed to improvement between the drug and placebo "wasn't statistically significant." It also said the drug "was not associated with statistically significant clinical benefits" and had no reduction in detection, no clinical improvement, no declined mortality, or time to clearance. Additionally, remdesivir treatment was stopped early more often than those on placebo because of adverse events, 12 percent versus 5 percent.
The Lancet-published trial was smaller than the ACTT study—the Lancet study only had 237 patients whereas the ACTT study had 1,063—the results are quite harsh. Even in the larger ACTT study, the improvement was only shown to be minor. Fauci noted that the drug only showed a 31 percent faster improvement, which by itself wasn't statistically significant, but showed a proof of concept.
Gilead CEO Daniel O'Day recently said that mass quantities of the drug are ready for distribution if the FDA gives the drug emergency status, which clears it for distribution without needing a longer, more formal approval process.