Early June: Remdesivir Clinical Trial Shows Promise Against COVID-19
COVID-19 patients administered the investigational antiviral drug remdesivir were 65% more likely to exhibit clinical improvement according to preliminary research findings announced Monday by Gilead Sciences, a California-based biopharmaceutical company.
Gilead’s Phase 3 trial involved administering 5-day and 10-day trials of remdesivir to hospitalized patients with moderate COVID-19 pneumonia. The study found that patients on 5-day trials of remdesivir were 65% more likely to have clinical improvement at day 11 compared to patients receiving standard care.
The 10-day trial group also showed positive trends but did not reach the level of statistical significance.
“These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients,” Francisco Marty, MD, associate professor of medicine at Harvard Medical School, said in a company press release.
Early May: FDA Authorized Hospital Use of Remdesivir
On May 1 the U.S. Food and Drug Administration issued an emergency use authorization allowing remdesivir to be administered to hospitalized patients with blood oxygen levels at or below 94%, “requiring treatment with supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation.”
It should be noted that emergency use authorization, however, is different, however, from FDA “approval.” The emergency use authorization means that while the FDA has not conducted the research it would ordinarily require to approve the drug for treating COVID-19, the agency is still allowing remdesivir to be used on patients due to the state of emergency.
The agency’s emergency use authorization form states that the drug carries with it risks of hypotension and elevated liver enzymes which can lead to liver damage in patients.
Late April: NIH Remdesivir Study Generated Controversy
Results of a National Institutes of Health clinical trial announced in late April generated heated debate.
The study, which was based on the median recovery times of patients taking remdesivir as opposed to a placebo, found remdesivir reduced coronavirus fatalities from 11.6% to 8% and reduced the duration of illness from 15 to 11 days in patients with advanced COVID-19 and lung involvement.
However, controversy arose over remdesivir being given to the placebo patient group after the study ended. While the NIH has stated that it was the moral thing to do, some health scientists point out that this contaminates any additional data that comes from a study that, as of this publication, has not been released from peer-review.
Other scientists have expressed concern that time taken to recover from COVID-19 is not a solid metric for approving remdesivir as the new baseline treatment for COVID-19 patients. Remdesivir was found to have a 3% improvement rate over the placebo in preventing COVID-19 deaths. The fact that some COVID-19 patients naturally recover from the virus may have obfuscated that result both in terms of fatalities “prevented” and recovery time “reduced.” Additionally, though 3% sounds like an improvement, it was not statistically significant, meaning that the results cannot be stated to be based on remdesivir as opposed to chance.