On Friday, a drug called remdesivir was green-lighted by the FDA for emergency use in hospitalized coronavirus patients after a preliminary trial by the National Institutes of Health showed the antiviral medicine helped them recover about 31 percent faster than patients who received a placebo.
Locally, a trial is already under way using remdesivir in very ill COVID-19 patients on ventilators at Sarasota Memorial Hospital.
Nine people have already received it intravenously at Sarasota Memorial Hospital, which was one of the first in the southeastern United States to enroll in a trial using remdesivir in late-stage coronavirus patients, said Dr. Kirk Voelker, medical director of clinical research.
“The main question I get asked is, 'Does it work?' Because they have already released some preliminary trial data from a different trial. And the answer is, 'I don’t know,'" Voelker said. "And this is the reason: In our trial we are giving it to every patient that qualifies. But they are sick. They are on mechanical ventilation. They are in the intensive care unit.
“Patients are too sick and have too many problems for me to even begin to guess on the effectiveness,” he said.
Sarasota Memorial is one of 155 centers across the country testing the drug in a trial that began about six weeks ago. An estimated 1,500 patients are expected to be enrolled overall, Voelker said.
Unlike the NIH trial, this is not a randomized trial in which some patients get a drug and others get a placebo.
“The advantage is we are giving it to every patient who is on a breathing machine and qualifies,” said Voelker. Patients experiencing organ failure do not qualify.
Typically, it can take six months or more to crunch data from clinical trials, but the urgency of the coronavirus pandemic could shorten that, Voelker said. Still, it’s unclear when results could be released.
In the meantime, the FDA authorization means more hospitalized COVID patients could get treated with remdesivir, which is made by Gilead Sciences. The pharmaceutical giant has said it will donate 1.5 million vials and help distribute them across the nation.
The drug failed to work against hepatitis and Ebola, but has shown some success in attacking a range of coronaviruses. How much it will cost on the market, if approved by the FDA for widespread use, is not yet known.
There is no other drug treatment known to work against coronavirus, and a vaccine is expected to be 12-18 months away.
