STAT News reported last April 16 that COVID-19 patients being treated with an experimental drug called remdesivir have been recovering from the virus quickly.
The health-oriented news website was able to obtain a video of a conversation about the trial by the team leading it. According to them, the University of Chicago has been treating severe COVID-19 patients with Gilead Sciences’ antiviral medicine in a closely watched clinical trial.
Image Credit: GILEAD SCIENCES via AP
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The University of Chicago Medicine recruited 125 COVID-19 patients into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe symptoms while all have been treated with daily infusions of remdesivir.
STAT News explains that the trial is investigating 5- and 10-day treatment courses of the drug. Its primary goal is a statistical comparison of patient improvement between the two treatment arms. Improvement is measured using a seven-point numerical scale that encompasses death (at worst) and discharge from hospital (at best), with various degrees of supplemental oxygen and intubation in between.
Most of the patients seem to have responded positively to the treatment, recovering from the virus in less than a week.
“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.
“It’s always hard,” she said in the video 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.”
“Most of our patients are severe and most of them are leaving at six days, so that tells us [the] duration of therapy doesn’t have to be 10 days. We have very few that went out to 10 days, maybe three,” Mullane added.
The drug has shown to be effective in multiple studies in animals at preventing and treating coronaviruses related to COVID-19, including SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome).
Several trials of the drug are ongoing simultaneously. Gilead is sponsoring tests of the drug in 2,400 patients with severe COVID-19 symptoms in 152 trial sites around the world as well as in 1,600 patients with moderate symptoms at 169 trial sites.
Gilead announced it expects results from the trial by the end of the month.
“We understand the urgent need for a COVID-19 treatment and the resulting interest in data on our investigational antiviral drug remdesivir,” the company said in a statement to CNN. However, it caveated that a few stories on positive results are still just stories.
“The totality of the data needs to be analyzed in order to draw any conclusions from the trial. Anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of remdesivir as a treatment for COVID-19,” Gilead said.
Mullane has confirmed the authenticity of the video but declined to officially comment on the progress of the clinical trials.
In a statement, the University of Chicago Medicine said: “drawing any conclusions at this point is premature and scientifically unsound.”
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