A National Clinical Trial Bolsters Efforts to Develop Treatments for COVID-19
As experts across the globe race to advance measures to combat COVID-19, researchers and clinicians at The University of Texas Health Science Center at Houston (UTHealth) are leading a clinical trial at Memorial Hermann-TMC aimed at preventing progression of the disease.
In August, a team of physician-scientists at UTHealth received a multimillion-dollar grant from the National Center for Advancing Translational Sciences, part of the National Institutes of Health, to examine the efficacy of convalescent plasma infusions in patients infected with the SARS-CoV-2 virus, which causes COVID-19 disease.
“This is the first and largest trial to actually see if convalescent plasma infusions stabilize and/or better treat hospitalized patients with symptomatic COVID-19. The National Institutes of Health and its National Center for Advancing Translational Science Institute have identified this as one of its most important clinical trials for determining the treatment of COVID-19,” said Dr. David McPherson, chair of the Department of Internal Medicine at McGovern Medical School at UTHealth and medical director of the Memorial Hermann Heart & Vascular Institute-Texas Medical Center. McPherson also serves as principal investigator for the UTHealth Center for Clinical and Translational Sciences, the awardee of the grant.
Plasma is the liquid component of blood, and convalescent plasma is the liquid component of blood from someone who is recovering from an illness—in this case, the novel coronavirus (COVID-19). The premise behind plasma therapy is that convalescent plasma contains antibodies from the virus, so infusing that plasma into the bloodstream of a sick individual should, in some cases, provide antibodies that might neutralize the virus and help the infected person heal.
“Convalescent plasma is one of the most promising interventions we have for COVID-19 because we’ve been using it for 100 years,” explained Dr. Henry Wang, professor and executive vice chair of research in the Department of Emergency Medicine at McGovern Medical School at UTHealth and attending physician at Memorial Hermann-TMC.
Wang has been one of the leaders of the convalescent plasma therapy initiatives at UTHealth since April when he and others first began administering it through expanded access protocols led by the Mayo Clinic. He and his UTHealth co-investigators Dr. Luis Ostrosky, professor of infectious diseases and medical director for Epidemiology at Memorial Hermann-TMC, and Dr. Bela Patel, vice dean of Healthcare Quality and the division director for Critical Care Medicine at McGovern Medical School at UTHealth and executive director of Critical Care for Memorial Hermann-TMC, were instrumental in bringing Memorial Hermann Health System into the expanded access trial as one of the lead patient enrollees.
Now, this NIH-funded trial will help provide insight into the efficacy of convalescent plasma and highlight which patients would most benefit from the therapy. It should also conclusively settle the controversies regarding the use of convalescent plasma for COVID-19.
“We’re in the midst of a pandemic and no one knows what actually works to help people recover—that’s why this clinical trial is so important,” Wang said. “It’s promising because we have practical experience with convalescent plasma—we used it for the Spanish Flu, we used it for MERS, for SARS, for Ebola.”
He added, however, that if the therapy proves effective for COVID-19, it won’t mean convalescent plasma will work for every patient.
“We want to give people hope, but we don’t want to give them false hope,” Wang said. “It will be useful in a subset of patients, but not all, so we need to know which patients. We want to give people the right kind of treatment.”
Even more, not all plasma units are created equal.
“We are learning that the strength of convalescent plasma varies with donors, and thus may have different benefits,” Wang explained. “Because we started these clinical trials months after the pandemic began, there are still uncertainties. But we’ll have more answers soon.”
The NIH-funded trial—one of the first of its kind in the country and run by UTHealth, New York University, the University of Miami and the Albert Einstein College of Medicine—is a randomized, Phase II clinical trial, which means that the researchers and clinicians participating do not know if patients received the plasma or a placebo.
Wang reiterated that the trials have been a team effort between everyone involved. He added that, ultimately, the program is groundbreaking in the way researchers have come together under the threat of a pandemic to accelerate what may become lifesaving therapies.
“The most innovative thing we have done this year is that we’ve learned how to work together and accelerate the research process,” Wang said. “Each of these trials is typically a five- to seven-year journey, and we’ve managed to compress that into five to seven weeks. It shows what is possible when we break down the research process to its most essential pieces, work together as a team, and learn to be creative.”
By: Alexandra Becker