RICHMOND, Va. (WWBT) - Friday, the Food and Drug Administration (FDA) issued an emergency use authorization for remdesivir “for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.”
The preliminary results from phase three of the drug show that it is effective against treating COVID-19.
In addition to 180 trial sites across the nation, VCU Health was among the first medical centers on the East Coast to begin trials.
"A few weeks ago all we had was hope and one of the goals of doing this trial is to build a bridge between hope and reality,” said VCU Health’s Dr. Arun Sanyal. “In the clinical trial that Gilead released results on this week, which is our trial for patients with severe COVID-19, VCU Health has enrolled 21 participants in the trial. In our other remdesivir trial, a trial for patients with moderate COVID-19, 15 participants have enrolled, as of April 30.”
Dr. Sanyal is a liver specialist at VCU Health and the principal investigator of remdesivir clinical trials at VCU Health.
“These trials compared administering a five-day and a 10-day dosing duration for treatment at 180 sites, including VCU Health. Both treatments were effective so somewhere between 55-65% of people fully recovered within the 28-day timeframe that the study followed the patients," Dr. Sanyal said.
Dr. Sanyal says the results suggest that the five-day and the 10-day treatment are about equally effective and the side effect profile is similar but manageable. He adds that people who started treatment with the first 10 days of illness did better than those who began treatment later in the course of having the illness.
“A similar number, between 55-60% of the patients, got discharged from their hospital during that time. Very importantly, the trial had between an 8-11% mortality rate across the sites. So compared to historical controls who had similar severity of the disease, this seems encouraging,” Dr. Sanyal said.
While this is good news, in the long run, Dr. Sanyal admits that it’s still too early to call this a miracle drug, but it does open the door to more treatment options in the future.
“The disease runs through different phases and the needs of the patient change as they go from the first to the last phase so there’s a lot of room for continuing innovation and improved therapeutics,” the doctor said.
Dr. Sanyal says VCU Health is in the process of beginning other trials with hopes to tailor the so that patients have the greatest likelihood of benefit while they are generating the evidence that will help larger populations with the disease.
“This is very encouraging news for patients with COVID-19 disease,” Dr. Sanyal said. “We now have high-quality scientific evidence showing there’s at least one treatment where we can say we do have scientific evidence that it works and we know how well it works.”
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