Early results from clinical trials of remdesivir, an antiviral drug that has been tested in Colorado hospitals on patients with COVID-19, show that those treated with the drug may be getting better faster, with fewer deaths.
“What I can say is that many patients have gotten better,” said Dr. Thomas Campbell, professor in the CU School of Medicine.
He’s one of the physicians leading remdesivir clinical trials at UCHealth University of Colorado Hospital. “Many patients have gotten well enough to go home.”
Early results from a trial that started February 21 of 1,063 patients sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, showed that patients hospitalized with severe COVID-19 and treated with remdesivir had an average recovery of 11 days, compared with 15 days for those who received a placebo. The results also suggested a decrease in the mortality rate from 11.6 percent in the placebo group, to 8 percent in the group that received the drug.
“It's very exciting because if the data support that conclusion then it could be that remdesivir will be the first proven effective treatment for COVID-19,” Campbell said. “Up until now we've had no proven effective treatment.”
But, Campbell cautioned that the results are preliminary and have not yet been released by NIAID nor peer reviewed.
“By some measures, the remdesivir arm did better than the placebo arm. So that is potentially very exciting news, but we will need to actually see the data,” Campbell said.
In a press briefing at the White House Wednesday morning, Dr. Anthony S. Fauci, director of the NIAID, told CNN that the drug shows promise.
"Although a 31 percent improvement doesn't seem like a knockout 100 percent, it is a very important proof of concept," Fauci said. "What it has proven is that a drug can block this virus."
In Colorado, patients have been enrolled in the NIAID sponsored clinical trials of the drug at Denver Health and the Rocky Mountain Regional Veteran Affairs Medical Center. They are among more than 100 locations around the world where the trial was conducted.
"It's not that it's going to cure this disease, but if it makes the patients have a disease that is less severe and shorter, that is very optimistic, particularly at this time if it's all that we have," said Dr. Maria Frank, medical director for the Denver Health Biocontainment Unit and one of the lead investigators of the Denver Health trial.
"The concept is in a way similar to Tamiflu, it won't cure it, but it will shorten the length of the disease. And most people that actually have influenza and receive Tamiflu will have a less severe disease. So in a way, if we can achieve that and have something in our toolbox, that is optimistic."
Frank couldn't share details of the trial at Denver Health including the number of participants or results from those patients because of NIH restrictions, but she did say that patients deserve some praise.
"Patients that actually agree to participate and families that agreed on behalf of the patients make a big difference," she said. "Without our communities and our patients agreeing to participate in improving the science, then this wouldn't be possible. "
At UCHealth University of Colorado Hospital, 31 patients have been enrolled in other trials sponsored by the drug maker, biotechnology company Gilead Sciences Inc..
The Gilead sponsored trial is aimed at understanding dosing, safety and side effects.
“All drugs have potential side effects,” Campbell said. “It requires studying them in large numbers of patients to be able to detect uncommon side effects.”
Remdesivir is given once a day by transfusion for up to ten days, but early results from the clinical trials have shown that the drug is effective after being administered for just five days. The shortened time means less medicine per person.
Remdesivir works by preventing the virus from replicating in the body, it has not been approved or licensed anywhere in the world. Remdesivir was developed over a decade ago, but was primarily aimed at treating Ebola. In a large trial comparing multiple treatments, remdesivir was not found to be as effective against that illness.
Gilead said it plans to submit the data for peer-review in the coming weeks.