Houston Methodist Hospital-led FDA Approved Study Finds COVID-19 Plasma Therapy Safe with 76% of Patients Improving

Houston Methodist Hospital-led FDA Approved Study Finds COVID-19 Plasma Therapy Safe with 76% of Patients Improving

Houston Methodist Hospital recently wrapped up a critically important convalescent study with national or even global implications. The study reveals that COVID-19 convalescent plasma therapy appears to helps patients infected with SARS-CoV-2 based on the results of a peer-reviewed study revealing that 19 out of the 25 participating patients’ health condition improved, including 11 discharged from the hospital. The findings have been published in the American Journal of Pathology. These results represent the first peer-reviewed publication on convalescent plasma in the United States.

TrialSite News provides a breakdown of this study, the players and, importantly, the implications of the results.

How was this emergency study funded?

Funding came 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.

Why are these results notable?

This report is the result of the country’s first peer-reviewed study of an investigational treatment for severe to critical COVID-19 patients. It was reported nationwide when the study commenced that Houston Methodist Hospital was the first to perform experimental plasma treatment against COVID-19.

What is convalescent plasma?

Convalescent plasma is an experimental treatment involving what is actually an old method of combating infectious diseases. The blood of those with recovered from COVID-19 contain antibodies, that is, molecules that have learned to identify and resist the pathogens involved, such as the SARS-CoV-2 virus. Using a procedure the researchers separate plasma, a component of blood that contains the antibodies, and thereafter administer it to the COVID-19 patient. The premise:  these antibodies from a recovered person have been transferred to the sick person and can now help them reject the SARS-CoV-2 pathogen more efficiently.

The Relevance of Houston Methodist Hospital in the Effort

Houston Methodist Hospital became the first academic medical center in the United States to transfuse plasma from recovered COVID-19 patients into two critically ill patients on March 28, 2020.

Was this an FDA approved study?

Yes. Houston Methodist Hospital first treated patients under emergency guidelines from the U.S. Food and Drug Administration and on April 3, 2020, received approval from the FDA to open the trial to patients as an investigational new drug. This rapid approval by the FDA opened access to convalescent plasma treatment for COVID-19 patients.

How does University of Texas Austin fit in the study?

Investigators at UT Austin collaborated with Houston Methodist Hospital. They developed an antibody test and selected recovered patients with the highest levels of antibody response for donation.

Was there any adverse events in the study?

No. And in fact, any complications observed were consistent with findings reported for COVID-19 disease progression and wasn’t due to the plasma transfusion.

What is the study conclusion?

Convalescent plasma therapy is a safe treatment option for patients with severe COVID-19 disease. Of note, the Houston Methodist Hospital findings are similar reported success from a number of  small case studies.

Why is this study’s impact even greater?

To date, this is the largest cohort of convalescent plasma patients worldwide assessed for outcomes pertaining to convalescent plasma transfusion for COVID-19, according to the recent announcement in the University of Texas Austin online news site UTNews. Recently published results represent the first peer-reviewed publication on convalescent plasma in the United States

What were some additional findings?

The study team found that the patient outcomes after plasma therapy were comparable to those observed and published recently on a compassionate-use basis with the antiviral drug remdesivir (note in that case the investigational drug reduced the duration of sick time a few days).

Who is the study’s corresponding author & why did they make history?

James M. Musser, chair of the Department of Pathology and Genomic Medicine at Houston Methodist, commented, “While physician scientists around the world scrambled to test new drugs and treatments against COVID-19 virus, convalescent serum therapy emerged as potentially one of the most promising strategies.” Dr. Musser continued, “With no proven treatments or cures for COVID-19 patients, now was the time in our history to move ahead rapidly.”

Who was the study’s Principal Investigator?

Eric Salazar, assistant professor of pathology a genomic medicine with the Houston Methodist Research Institute

Will a larger randomized controlled study be considered?

Yes. Importantly, Houston Methodist Hospital implemented this emergency treatment, with the support of the FDA, to save lives during the COVID-19 pandemic. The authors of this study also understand the importance of randomized controlled trials to produce therapeutic evidence. 

Hence, the Houston Methodist Research Institute will consider a clinical trial to investigate in more detail variables in a controlled way, such as the timing associated with the convalescent plasma transfusion adjusted for patient biometrics, antibody levels in donor plasma and numerous other parameters needed for the ongoing refinement and optimization of this therapy, reported UTNews.

Houston Methodist Research Institute

Houston Methodist Research Institute is part of a major academic medical center (Houston Methodist Hospital) that is affiliated with Weill Cornell Medical College and the Weill Cornell Graduate School of Medical Sciences of Cornell University. The research group strives to build research teams that bridge the boundaries between specialties, innovate in health care technology, and train current and future clinicians and researchers from around the world in translational medicine and advanced technology. By streamlining the path to discoveries into the clinic with inventive development practices, they seek to improve global health. Houston Methodist Research Institute conducts research in advanced fields such as Precision Medicine as well as Biotherapeutics and regenerative medicine.

Houston Methodist Hospital

The flagship hospital of Houston Methodist located in the Texas Medical Center in Houston, Texas. Established in 1919 during the height of the Spanish influenza epidemic as an outreach ministry of Methodist Episcopal Church, Houston Methodist comprises seven community hospitals, a continuing care hospital as well as several emergency centers and physical therapy clinics throughout greater Houston.

Houston Methodist Hospital has been ranked consistently as “One of America’s Best Hospitals,” according to U.S. News and World Report—with recognized specialties such as cardiovascular surgery, cancer, epilepsy treatment and organ transplantation.

Lead Research/Investigator

Eric Salazar, MD, PhD, assistant professor of Pathology an Genomic Medicine with the Houston Methodist Research Institute

James M. Musser, chair of the Department of Pathology and Genomic Medicine at Houston Methodist

Other authors were involved with this critically important effort and can be noted in the published study results in the American Journal of Pathology