A University of Chicago drug trial using Gilead Science’s antiviral drug Remdesivir has shown very promising results in treating COVID-19. The vast majority of patients taking the drug reported “rapid recoveries in fever and respiratory symptoms” and were discharged within a week.
If deemed safe and effective by the FDA, the drug could be rapidly approved for distribution.
Remdesiver is in the early third stage of trials. There would normally be several months of additional human trials and mountains of data to check. But with the crisis upon us, it’s likely there will be shortcuts.
Gilead’s stock rose 8 percent on the news of the promising trial.
The University of Chicago Medicine recruited 125 people with Covid-19 into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe disease. All the patients have been treated with daily infusions of remdesivir.
“The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital.
There are other trials of the drug proceeding at other medical institutions and it’s impossible to say at this point whether the drug is safe and effective. The results of this particular study were released by STAT after the site got a hold of a videoconference of doctors and researchers discussing the results.
The doctor who was overseeing the study remains cautious.
Mullane, while encouraged by the University of Chicago data, made clear her own hesitancy about drawing too many conclusions.
“It’s always hard,” she said, because the severe trial doesn’t include a placebo group for comparison. “But certainly when we start [the] drug, we see fever curves falling,” she said. “Fever is now not a requirement for people to go on trial, we do see when patients do come in with high fevers, they do [reduce] quite quickly. We have seen people come off ventilators a day after starting therapy. So, in that realm, overall our patients have done very well.”
She added: “Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out to 10 days, maybe three,” she said.
The placebo study involves using a control group, which is given a pill that looks exactly like Remdesivir, but is made of something inert — what used to be called “sugar pills.” It’s one of the last steps before the FDA approves a drug.
With only two fatalities in treating 226 people with severe symptoms, this could be, if not a miracle drug, then certainly a major breakthrough in treating COVID-19. It’s likely we’ll see more results from other trials in the near future, at which time we’ll have a better idea of the true potential of this drug.
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