Drugmaker Gilead Sciences Inc., known to many for lifesaving medications used to combat HIV, may have some good news soon about its experimental drug remdesivir which is currently being studied as a treatment for the novel coronavirus.
StatNews obtained a recorded video discussion among medical researchers at the University of Chicago where two Phase 3 clinical trials involving 125 people with COVID-19 being treated with the drug.
Of those patients, 113 were experiencing severe symptoms of the disease. All the patients have been receiving daily infusions of remdesivir.
According to StatNews, patients in the study saw their fevers drop and some were able to have ventilators removed in a day.
Slawomir Michalak, a 57-year-old factory worker from a suburb west of Chicago, told StatNews he went to the University of Chicago Medicine hospital on Friday, April 3, when he spiked a 104 fever and found it difficult to breathe.
He was put on oxygen and given the option to join the severe coronavirus trial.
On Saturday, April 4, he received his first infusion of the drug. “My fever dropped almost immediately and I started to feel better,” said Michalak.
The next day, he received a second dose and was able to breathe without supplemental oxygen. After two more daily treatments of remdesivir, he was well enough to be discharged on Tuesday, April 7.
It’s only one man’s story, but it’s encouraging.
Former FDA Commissioner Dr. Scott Gottlieb told CNBC News that while remdesivir has shown some unwanted side effects, like increased liver enzymes which eventually self-correct, the first wave of drugs developed against viruses often aren’t perfect “but they work.”
Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital said in the video, “The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish.”
If safe and effective, it could become the first approved treatment against the disease.
In a statement, however, Gilead warned that 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.”
A University of Chicago spokesperson told MarketWatch on Friday morning, “Drawing any conclusions at this point is premature and scientifically unsound.”
Gilead is currently overseeing 152 separate clinical trials around the world involving 2,400 severe patients. Additionally, there are 169 trials following 1,600 moderate COVID-19 patients.
Until the trials are closed and the numbers crunched we won’t have a clear idea as to how useful the drug might be against coronavirus.
Gilead told StatNews it hopes to have results for its trial involving severe cases in April. During the video discussion, Mullane reportedly shared that data for the first 400 patients in the study would be “locked” by Gilead this week, meaning some results might be made public soon.