The University of Toledo Medical Center has begun recruiting patients to participate in a National Institutes of Health study seeking to identify which coronavirus treatments are most effective and deserve more attention in clinical trials.
The medical center is one of the first sites in the nation to enroll patients in the trial, known as the Big Effect Trial, which aims to have 40 sites with participants soon. The study will look to weed out ineffective treatments and expedite therapeutics that show significant benefits to patients struggling with the virus by testing hospitalized adults who need oxygen or mechanical ventilation and consent to participation.
As part of the study, the former Medical College of Ohio Hospital will seek to have at least 30 patients participate in total, and has 10 enrolled already, said Dr. Michael Ellis, an infectious disease expert, who is the chief medical officer at UTMC. The study is an important project that will help save lives as the nation awaits mass vaccine distribution, he further said, adding that it would also go a long way toward pinpointing which therapies work most effectively in treating the virus should new strains emerge down the road.
“We can expect that COVID is going to be around for awhile, until we have really good vaccine compliance in the community,” Dr. Ellis said. “And so as long as COVID is around, which we don't know if this will be something that comes around every year or how long it will last, we need to have therapeutic options for this virus.”
“These therapies are not directed exactly at the virus, they’re directed at the inflammatory response that the body makes to an infection,” he said, noting that the study would help lend expertise to any strain of the virus.
UTMC will treat patients who enroll in the trial with a pairing of remdesivir, a proven benefit to treating coronavirus infections, and either risankizumab or lenzilumab, two monoclonal antibodies being investigated as potential treatments for the virus.
Dr. Ellis said he sees UTMC’s participation in a larger effort around the country to find the most effective ways to treat the virus and save lives.
“The way I look at it is, everybody around the country is doing their part,” he said. “And this is a way that we can do our part. One of our objectives has been to participate in the overall public health response and this is our way of contributing to the larger program of developing therapeutics.”
After the initial portion of the trial, UTMC will begin a second phase using a placebo-controlled trial that looks to examine the safety and efficacy of using each of the two monoclonal antibodies paired with remdesivir, versus remdesivir alone.
In a news release to announce the study, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci said the study will create an “efficient way of finding those promising treatments and eliminating those that are not.”
“The goal here is to identify as quickly as possible the experimental therapeutics that demonstrate the most clinical promise as COVID-19 treatments and move them into larger-scale testing,” he said.
The participants in the study throughout the country will be assessed daily by clinical staff while hospitalized, and will undergo visits from staff once discharged, also. The trial is funded fully by the NIH.
First Published January 5, 2021, 12:00 p.m.
