The potential antiviral drug for COVID-19, Remdesivir fails in its first randomized clinical trial, report shows.
A week ago, everyone's hope was up that remdesivir could treat COVID-19. The Chinese clinical trial, however, showed that the drug had not been successful based on the draft documents that were posted on the website of the World Health Organization (WHO), but later removed. The report is said to have indicated that the drug did not improve patients' condition nor reduce the presence of the pathogen in the bloodstream.
The results have been taken down on the said website.
Results showed that the study had 237 patients; remdesivir was administered to 158 and was compared to 79 patients who received placebo treatment. After a month, 13.9% of the patients taking the drug had died, compared to 12.8 percent who took the placebo. The trial was ceased early because of side-effects. The report concluded that "Remdesivir use was not associated with a difference in time to clinical improvement."
Gilead Sciences released, the developer of the drug, stated on its Twitter account. Dr. Merdad Parsey, chief medical officer of Gilead Sciences, posted on Twitter this statement:
The statement said that the "study investigators did not provide permission for the publication of the results." Gilead Sciences also said that they believe that the post included inappropriate characterizations of the study.
Parsey also explained that "the study was terminated due to low enrollment and, as a result, it was underpowered to enable statistically meaningful conclusions." He added that "As such, the study results are inconclusive, though trends in the data suggest a potential benefit from remdesivir, particularly among patients treated early in the disease. "
In conclusion, the statement said, "We understand the available data have been submitted for peer-reviewed publication, which will provide more detailed information from this study in the near future."
New England Journal of Medicine showed 68 percent of patients were improving on remidisivir. The study, however, was not an official trial but a collation of data from patients administered with the drug for "compassionate use." It was also not compared to any controls. Gilead scientists at the time warned the public that the results are not conclusive.
It also showed positive results when a study revealed that it showed rapid recovery in almost all of more than a hundred severely ill patients. The said results were leaked and eventually published to Stat news, a health care industry publication.
On Thursday, Gilead said there are still multiple ongoing Phase III studies to provide additional data necessary to determine the potential of remdesivir as a COVID-19 treatment. These studies will provide information on whom to treat when to treat, and the duration of the treatment.
Remdesivir was also found effective in treating the disease in monkeys based on the recent US National Institutes of Health animal study.
To date, there is no treatment for COVID-19 approved by the US Food and Drug Administration. The FDA reports that there are 72 ongoing active trials, and 211 are still in the planning stages as of April 19.
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