Maine Medical Center has joined two worldwide human clinical trials for remdesivir, a possible treatment for moderate and severe cases of COVID-19.
The Portland hospital enrolled its first patient with severe symptoms in the clinical trial on April 9, and Maine now has three patients enrolled in the study. No patients at Maine Med with moderate cases of the disease caused by the coronavirus are yet enrolled.
Dr. David Seder, the principal investigator for the trial at Maine Med, said in a phone interview with the Press Herald that the anti-viral medication has strong potential because if it works it can prevent the virus from replicating in the body.
“This is, in my view, the most promising anti-viral drug that is this far along in the development process,” Seder said.
Public health experts who are not part of the study have expressed hope in initial research conducted before the human clinical trials, but stress that the clinical trials are crucial. A clinical trial is a research study conducted with human beings to evaluate the effectiveness of a new treatment, drug or therapy.
“Results are indeed hopeful and promising,” Eric Feigl-Ding, an epidemiologist and health economist at the Harvard T. H. Chan School of Public Health, said in a tweet. But Feigl-Ding said the clinical trials will be most telling.
The two studies that Maine Med is participating in will include up to 7,600 patients worldwide.
All Maine Med patients hospitalized for COVID-19 who meet the criteria will be asked if they want to join the clinical trial. Seder said that could be as few as 10-20 patients or as many as 50-100 depending on how many patients the hospital cares for in the next few months. Maine Med had 24 COVID-19 patients on Tuesday, a spokeswoman confirmed.
Study participants must be at least 12 years old, hospitalized with COVID-19, have no underlying significant kidney or liver dysfunction and not be pregnant or breastfeeding, the hospital said in a statement.
The drug was already being developed to treat Ebola, but it also may work for COVID-19. The drug is not yet approved by the U.S. Food and Drug Administration but is on an accelerated timetable because of the novel coronavirus pandemic.
Seder said the drug could be available in a few months to the general population, but because it is intended for patients with moderate to severe symptoms, it would only be available to those who are hospitalized. Still, if it works, it could save lives and preserve hospital resources, he said.
The drug, developed by California-based Gilead Sciences Inc., made national news this month for its potential as a treatment for COVID-19. Public health experts have said that effective treatments are key tools needed to help reopen society while scientists are working on a vaccine, which will take at least a year.
A preliminary study of 53 patients showed remdesivir may be effective against COVID-19, leading to more comprehensive studies.
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