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Gilead Sciences announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with its experimental antiviral remdesivir administered under a compassionate trial program.
The study, published in the New England Journal of Medicine, involved 53 severely ill patients across US, Canada and Europe who were given remdesivir as part of a “compassionate use” program.
After receiving the drug, more than half the patients on ventilators were taken off, and 47% of the patients were discharged from the hospital. Eight additional patients were left out of the analysis: one due to a dosing error and seven because no information was available on how they fared.
The study was done with several significant limitations. It involved a very small number of patients in multiple countries, and it also had no controls, so it is impossible to know how much improvement would have happened if the patients were not given the drug. The study was also funded by Gilead Sciences, which produces remdesivir.
“Currently there is no proven treatment for COVID-19. We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful," said Jonathan D. Grein, MD, Director of Hospital Epidemiology, Cedars-Sinai Medical Center, Los Angeles, and lead author of the journal article. “We look forward to the results of controlled clinical trials to potentially validate these findings.”
Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for the treatment of COVID-19.
Multiple large scale clinical trials are underway to evaluate the benefit of remdesivir for Covid-19, the disease caused by the novel coronavirus that has infected more than 1.65 million people worldwide and killed 100,000.
Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS.
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