University of Texas Health Science Center (Houston) Joins $8m Convalescent Plasma Study Funded by NIH

Sep 4, 2020 | Convalescent Plasma, COVID-19, News, University of Texas Health Science Center, UT Health

University of Texas Health Science Center (Houston) Joins $8m Convalescent Plasma Study Funded by NIH

University of Texas Health Science Center at Houston (UT Health) recently received an $8 million grant from the National Institutes of Health to study the effectiveness of convalescent plasma with a randomized, double-blind clinical trial.  This is part of a broader effort with the Center for Clinical and Translational Sciences, UTHealth, and The University of Texas Health Science Center at Tyler joining a study established by New York University (NYU) and Montefiore Medical Center/Albert Einstein College of Medicine to evaluate the safety and efficacy of convalescent plasma in hospitalized patients. Enrolling patients locally at Memorial Hermann-Texas Medical Center, the funding originates from a grant (3UL1TR003167-02S1) from the National Center for Advancing Translational Sciences, part of the NIH.

Convalescent plasma recently was approved for emergency use authorization by the U.S. Food and Drug Administration (FDA). As TrialSite reported, however, not without some controversy as to whether the evidence is sufficient enough for such an authorization. Initially headed for EUA, at one point the NIH was possibly seeking to intervene and shortly thereafter the FDA made the EUA call. 

Convalescent plasma has already been used by UTHealth physicians at its teaching hospitals under an expanded access framework from the U.S. Food and Drug Administration, which allows access to investigational therapies because there are no other viable treatment options for COVID-19.

The Study

This study is both randomized, meaning some patients will receive the plasma and some will receive placebo, and blinded, meaning the physicians won’t know which treatment the patient has received. “This rigorous methodology will once and for all shed light as to whether this intervention is useful and should be expanded. This is exactly the kind of research that we need to be conducting during the pandemic,” said David McPherson, MD, chair of the Department of Internal Medicine at McGovern Medical School and principal investigator for the Center for Clinical and Translational Sciences, the awardee of the grant. The team plans to enroll 400 patients in sites through UTHealth in Houston and UT Health in Tyler.

Other key co-investigators from McGovern Medical School include Henry Wang, MD, MS, professor and executive vice chair of research in the Department of Emergency Medicine; and Bela Patel, MD, vice dean of healthcare quality and division director for critical care medicine. At Memorial Hermann-TMC, Wang is an attending physician and Patel is executive medical director of critical care.

Principal Investigator Point of View

“Physicians have been using convalescent plasma to try to save patients during the pandemic, knowing that it is safe, but not knowing if it really works,” said co-investigator Luis Ostrosky, MD, a professor of medicine and epidemiology and vice chair of healthcare quality with McGovern Medical School at UTHealth. “A randomized, placebo-controlled trial is the standard to assess efficacy of an intervention. NYU started this important study, and as the incidence of COVID-19 started to go down in New York City, they looked for partners in new hot spots to help continue the study and we were asked to join. Now, we’re going to be able to conduct an ideal study in Houston to see if convalescent plasma is really effective against coronavirus.” Ostrosky is the medical director for epidemiology at Memorial Hermann-Texas Medical Center and an infectious disease specialist at UT Physicians.

Lead Research/Investigator

David McPherson, MD 

Source: Newswise

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