Madigan and JBLM participating in international COVID-19 treatment trial
Madigan Army Medical Center is in the third phase of a COVID-19 treatment trial alongside six other military treatment facilities.
The trial, sponsored by the National Institutes of Health, is an adaptive treatment trial designed to evolve alongside the pandemic and can continue as long as there is no definitive treatment for the disease, according to Dr. Rhonda Colombo, an infectious disease physician and the lead assistant investigator for the trial at Madigan.
Adaptive treatment trials allow for modifications of the trial design as data is collected, according to the U.S. Food and Drug Administration.
In the case of the trial Madigan is participating in, after the initial phase of the trial, the antiviral drug Remdesivir showed signs of reducing the recovery time for hospitalized patients with COVID-19. In each additional phase, Remdesivir has been used as the “control arm” of the study, according to Colombo.
All the participants in Madigan’s study are military beneficiaries — active duty or retired service members and their families — who have been diagnosed with COVID-19. Participants are given the drug intravenously.
In the first phase of the trial, investigators were measuring the recovery time of patients who had been hospitalized.
“It is not a symptomatic treatment per se, but more a treatment for the cause of the disease or symptoms,” Colombo said. “It seems to shorten the course of the illness in those hospitalized patients sick enough to require oxygen therapy.”
Now, in the third phase of the trial, investigators are comparing the drug Remdesivir with Remdesivir plus interferon beta-1a, an intramuscular injection traditionally used to treat adults with multiple sclerosis.
The study is double-blind, meaning neither the participants nor investigators know whether participants are receiving Remdesivir or Remdesivir plus interferon beta-1a.
Madigan and the other military treatment facilities — Brooke Army Medical Center, Navy Medical Center Portsmouth, Navy Medical Center San Diego and Walter Reed National Military Medical Center — are serving as study sites for the Uniformed Services University’s Infectious Diseases Clinical Research program. USU is one of many groups participating in the study which spans over 18 states and 10 countries and has had over 2,000 participants. The University of Washington is also a participant, as well as EvergreenHealth Infectious Disease Service in Kirkland and Providence Sacred Heart Medical Center in Spokane.
Madigan is also participating in a Department of Defense effort to collect 10,000 units of convalescent plasma by Sept. 30. Convalescent plasma is blood plasma — the yellow, liquid part of the blood that contains antibodies — collected from patients who have already recovered from COVID-19.
During a visit to Joint-Base Lewis McChord earlier this year, assistant Secretary of Defense for Health Affairs Thomas McCaffery said the DOD believes there is potential for the plasma to be converted into a treatment as a preventative measure.
The Armed Services Blood Bank Center — Pacific Northwest is accepting plasma donors who have had a documented positive COVID-19 test but have since recovered.
Since the effort to collect plasma began in early June, the DOD says it has collected 65% of its 10,000-unit goal.
This story was originally published September 10, 2020 at 10:00 AM.
