A number of drugs have been held up as promising treatments for COVID-19 coronavirus. A few have already been put into use. The most well-known of these is Hydroxychloroquine. However, another drug, Remdesivir, is also showing strong results in clinical trials. Could this be the answer for treating COVID-19?
A video was released by Stat News today. In it, a scientist who is the head of clinical trials at the University of Chicago Medical School states that all of the patients from their most recent clinical trial for a drug to treat COVID-19 have been discharged from care. All told, 125 patients were treated and 123 of them were cured by the same drug.
That drug’s name is Remdesivir. It may have a funny name, but apparently it’s a serious weapon in the treatment of the COVID-19 virus.
The University of Chicago study was preceded by one published April 10 in the New England Journal of Medicine. In that study, 53 patients with severe symptoms of COVID-19, including 34 who were on ventilators, received Remdesivir by daily infusion.
Of the 53, 7 died. 6 of those 7 patients were on ventilators. The results were very promising, with minimal negative side effects. The authors of that study recognized that their research cohort was relatively small and that “measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy.” However, based on their findings, they recommend that Remdesivir continue to be used as a treatment for COVID-19 coronavirus. (1)
While Remdesivir was one of the earliest drugs recognized as a potential treatment for COVID-19, Gilead Sciences, its manufacturer, has been working on clinical trials of the drug. This is common when a drug is being used “off-label,” or for a disease or condition for which it was not originally designed or tested. Hydroxychloroquin (HCQ) faces the same scrutiny and is being tested in clinical trials around the world, also with positive results.
If Remdesivir continues to see positive outcomes in clinical trials, it is likely to get fast-track approval for use against COVID-19. With the results of these two trials, along with several other smaller trials, Remdesivir is likely to become the first drug fully approved for use against COVID-19. As of now, HCQ enjoys emergency FDA approval. It will require more trial results to get full approval as a treatment for COVID-19.
In the University of Chicago’s Phase 3 trial, 125 people were given Remdesivir on a daily basis. Of those, 113 had severe symptoms. Of the total, only 2 patients died. The other 123 were discharged. In the video mentioned above, Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital, 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 drug is also undergoing clinical trials in other locations. Gilead Sciences, like the rest of the world, remains cautiously hopeful that the results of those trials will match the University of Chicago results.
Dr. Mullane is also cautiously optimistic, but doesn’t want to draw too many conclusions just yet.
“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.
While the studies underway right now lack control groups, the sheer size and scope of the work being done may provide more confidence that Remdesivir can get the job done. There are currently more than 2,400 in 152 clinical trials across the world with severe COVID-19 and another 1,600 in 169 trials with moderate COVID-19.
That’s a large cohort and will provide an immense amount of date about efficacy and safety. The trial is looking at both 5 and 10 day treatment courses of the drug. The purpose is to compare relative patient improvements between the two courses. They’re using a 7 point numerical scale with discharge from treatment and the hospital at one (best result) end and death (worst result) at the other. The studies also consider various levels of oxygen supplementation and intubation/ventilator use as well.
While the “perfect” treatment for COVID-19 may not be at hand, the good news is we’re seeing some important, positive signs. For example, while the virus seems more transmissible than we originally thought, the severity of illness and mortality rate appear to be much lower than we thought. That means that we can likely manage the illness by protecting our vulnerable populations, with less concern about other, healthier people.
Yes, this is a serious illness. It’s a novel virus, which means we’ve never seen or been exposed to it before. However, that doesn’t mean we aren’t going to beat it. Stay safe, stay healthy and as always, keep the faith and keep after it!
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