The country's first peer-reviewed study of a COVID-19 treatment that transfuses blood plasma from recovered patients into critically ill patients shows 19 out of 25 patients improving, including 11 discharged from the hospital.
On March 28, Houston Methodist Hospital became the first academic medical center in the U.S. to transfuse plasma from recovered COVID-19 patients into two critically ill patients. Collaborators at The University of Texas at Austin developed an antibody test and selected recovered patients with the highest levels of antibody response for donation.
With no adverse side effects caused by the plasma transfusion, the study concluded that convalescent plasma therapy is a safe treatment option for patients with severe COVID-19 disease. To date, this is the largest cohort worldwide assessed for outcomes pertaining to convalescent plasma transfusion for COVID-19.
The findings are described in a paper published May 26 in The American Journal of Pathology. This is the first peer-reviewed publication on convalescent plasma use in the U.S.
"While physician scientists around the world scrambled to test new drugs and treatments against the COVID-19 virus, convalescent serum therapy emerged as potentially one of the most promising strategies," said James M. Musser, chair of the Department of Pathology and Genomic Medicine at Houston Methodist and corresponding author of the study. "With no proven treatments or cures for COVID-19 patients, now was the time in our history to move ahead rapidly."
Eric Salazar, assistant professor of pathology and genomic medicine with the Houston Methodist Research Institute, is the principal investigator. Members of the UT Austin team are Gregory Ippolito, a research assistant professor in the Department of Molecular Biosciences and assistant professor of oncology at Dell Medical School; Jason Lavinder, research associate in the Department of Chemical Engineering; Jimmy D. Gollihar, visiting researcher in molecular biosciences; and Andre C. Maranhao, postdoctoral fellow in molecular biosciences.
Patients were first treated under emergency use guidelines from the U.S. Food and Drug Administration and then received approval April 3 from the FDA to open the trial to more patients as an investigational new drug. This rapid approval granted by the FDA opened access to convalescent plasma treatment for COVID-19 patients.
Additional findings during this trial revealed patient outcomes after plasma therapy were similar to recently published results of patients treated on a compassionate-use basis with the antiviral drug remdesivir. The research team also concluded that any observed complications were consistent with findings reported for COVID-19 disease progression and did not result from the plasma transfusions. The study's overall findings were consistent with several other small case studies of convalescent plasma use for severe COVID-19 that have been recently reported.
Ultimately, although the convalescent plasma therapy administered on the front lines at Houston Methodist was implemented for emergency treatment, the study's authors recognize the important need for controlled clinical trials to determine its therapeutic efficacy. A randomized controlled trial is currently being considered at Houston Methodist, where they would also look more closely at variables such as timing of the transfusion after the onset of symptoms, the number and volume of transfusions adjusted for patient biometrics, antibody levels in donor plasma and numerous other parameters needed to effectively evaluate how to optimize this therapy. This would help address some questions, including whether patients would have better outcomes if plasma transfusions were administered sooner after the onset of symptoms.
This study was supported by funding from the National Institutes of Health, the Fondren Foundation, the National Institute of Allergy and Infectious Diseases, the Army Research Office, Houston Methodist Hospital and Houston Methodist Research Institute.
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