A leaked video from the University of Chicago has revealed that nearly all patients in a clinical trial of an experimental drug being used to treat COVID-19 enjoyed a rapid recovery and were discharged from hospital in less than a week.
Most of the patients were reportedly beset with severe respiratory complications. But now, after a daily course of the much-hyped drug remdesivir, they’re not.
In the video, Dr Kathleen Mullane, an infectious disease specialist at the University of Chicago Medicine hospital who is leading the clinical trial, said: “The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish.”
The signs are promising but patience is required
Dr Mullane was apparently encouraged by the University of Chicago data, but also hesitant about drawing too many conclusions.
“It’s always hard,” she said, referring to the fact that this particular test doesn’t include a placebo group for comparison. “But certainly when we start [the] drug, we see fever curves falling.
“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.”
Last month, as The New Daily reported, the World Health Organisation (WHO) enlisted 10 countries to rigorously test four of the promising anti-viral drugs on a large scale, largely with a focus to establish which, if any, can reliable reduce mortality.
One of these drugs was remdesivir, which had reportedly brought a woman sick with COVID-19 back from near-death.
Remdesivir was initially tested against Ebola with little success, but multiple studies in animals showed the drug could both prevent and treat coronaviruses related to COVID-19.
Reputation as a Lazarus drug
The US Food and Drug Administration has approved the emergency use of remdesivir on critically ill COVID-19 patients as a compassionate and last-resort measure.
Gilead Sciences, the drug’s manufacturer, is conducting two Phase 3 trials. There are also trials in train or recruting participants in China and France. The US National Institute of Allergy and Infectious Diseases is backing an expanded trial of the drug to be conducted at up to 50 sites globally.
According to news site STAT, to whom the video was leaked, Dr Mullane confirmed the authenticity of the footage but declined to comment further. In a statement, the University of Chicago Medicine said: “Drawing any conclusions at this point is premature and scientifically unsound.”
STAT contacted one of Dr Mullane’s patients, a 57-year-old factory worker from a suburb west of Chicago.
On April 3, after a high fever, shortness of breath and severe pain in his back, the man was admitted to the University of Chicago Medicine hospital. “He was given supplemental oxygen and agreed to participate in Gilead’s severe Covid-19 clinical trial,” according to the report.
After his first infusion of the drug, his fever dropped “almost immediately and I started to feel better.”
By his second dose on Sunday, the man said he was being weaned off oxygen. He received two more daily infusions of remdesivir and recovered enough to be discharged from the hospital on April 7, after four days of treatment.
A few encouraging words and the market went off
What amounted to a well-placed anecdote led to a sudden spike of more than 10 per cent in the share price of Gilead Sciences, the company developing and conducting two Phase 3 clinical trials of remdesivir.
Market analysts cautioned against investor enthusiasm based on a few remarks, and Gilead immediately issued a statement hosing down the excitement:
“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.”
The initial report was from STAT News, a Boston Globe Media outlet that has emerged as a leading and nimble news-breaker of COVID-related science stories. Since then, Dr Mullane’s comments have been re-published in dozens of media outlets around the world.
According to that report, the University of Chicago Medicine recruited 125 people with COVID-19 into Gilead’s two Phase 3 clinical trials.
Dr Mullane’s comments were made during a video discussion about the trial results with other University of Chicago faculty members. The discussion was recorded and STAT obtained a copy of the video, but didn’t publish it.