A New Study Confirms Remdesivir's Effectiveness as a Coronavirus Treatment
In a report published October 8 in the New England Journal of Medicine, researchers confirmed the benefits of remdesivir in treating people hospitalized for COVID-19.
Remdesivir, an antiviral drug, has an Emergency Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to treat people hospitalized for COVID-19. This approval means doctors can prescribe the intravenous (IV) drug for people infected with SARS-CoV-2 who have been hospitalized. While the drug was originally only approved for those who needed supplemental oxygen or ventilators to breathe, an expanded EEA from the FDA in late August reflects a growing belief among doctors that treating people who are not as sick will bring even more benefit Could - So Now Includes people with signs of respiratory infection but who do not yet need supplemental oxygen or the help of a ventilator.
Remdesivir inhibits the virus' ability to make more copies of itself and has helped both patients with early-stage COVID-19 and those with more advanced symptoms in studies.
In the latest report, researchers led by a team from the National Institute of Allergies and Infectious Diseases provide the final data on a study they first published in May. Ultimately, the researchers provided more detailed data on how the drug affected readings, including how long people were given supplemental oxygen or ventilators. All participants showed signs of a respiratory infection, mainly pneumonia, and 85% had a serious illness, which meant they had at least one of three symptoms: their blood oxygen levels were below 94% when they breathed indoor air; they needed additional oxygen; or they needed a ventilator to breathe. Among all participants - both with severe COVID-19 and with milder symptoms - those given remdesivir were able to be discharged from hospital an average of five days earlier than those given placebo.
"These data strengthen the value of remdesivir in hospital patients," says Dr. John Beigel, Associate Director, Clinical Research, Microbiology and Infectious Diseases, NIAID. While the preliminary study provided mortality data after 15 days, the full study tracked study participants for 28 days and found that 11% of those who received remdesivir died, compared with 15% in the placebo group. While this isn't a statistically significant difference (the study wasn't large enough to include a statistically sufficient number of deaths in each group), "it's still a significant improvement," Beigel says. He notes that mortality rates along with other measures, including the fact that people on remdesivir spent less time in oxygen and fewer days in the hospital, support the drug's overall benefit.
According to Beigel, the drug appeared to not only help people who had symptoms for more than 10 days, but also people who had symptoms for less than 10 days. This leads leading researchers to take a closer look at how the drug is affecting patients who are in earlier stages of COVID-19.
These studies look to see if remdesivir can decrease the progression of COVID-19 even in people who are out of the hospital and possibly prevent them from getting sick enough to need an admission. "To know how viral infections of the respiratory tract work and how this drug works would be useful," says Beigel. "There is no reason to believe that this would not work for our patients. But they have to do the study."
The only challenge right now is that remdesivir is an IV drug and the logistics of managing IV infusions for those out of the hospital could limit its use. However, the drug's manufacturer, Gilead, says it is testing an inhaled version of the drug that would be easier for patients to take.
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