Houston Leads Blood-Related COVID-19 Therapies

The U.S. Food and Drug Administration (FDA) continues to play a critical role in accelerating medical countermeasures to treat and prevent COVID-19 disease. 

As part of the response to this pandemic, the FDA announced on April 3, 2020, it is taking the lead on a national effort to facilitate the development of, and access to, two investigational therapies derived from human blood. 

These are called convalescent plasma and hyperimmune globulin are antibody-rich blood products made from blood donated by people who have recovered from the virus. 

The products can be administered to individuals diagnosed with COVID-19. 

According to the FDA, there are some limited data to suggest that convalescent plasma and hyperimmune globulin may have benefit in the COVID-19 illness. 

This is why the evaluation of these therapies in the context of a clinical trial and expanded access program is so important.

“This is an important area of research — the use of products made from a recovered patient’s blood to potentially treat COVID-19 in those affected by this illness,” said FDA Commissioner Stephen M. Hahn, M.D. 

“The FDA had played a key role in organizing a partnership between industry, academic institutions, and government agencies to facilitate expanded access to convalescent plasma.”

The FDA’s initial effort was focused on facilitating access to convalescent plasma for the treatment of COVID-19 disease through an emergency investigational new drug application (eIND) process. 

The FDA is facilitating the conduct of well-controlled clinical trials at academic institutions to rigorously evaluate the safety and efficacy of convalescent plasma, such as in Houston and Baltimore:

• On March 27th, Houston Methodist became the first in the nation to transfuse convalescent plasma collected from a recovered COVID-19 patient into one who is critically ill. The next day, the team provided convalescent plasma to a second critically ill patient.
• Arturo Casadevall, a Johns Hopkins infectious disease expert assembled a team of physicians and scientists from around the United States who are establishing a network of hospitals and blood banks that can collect, isolate, and process blood plasma from COVID-19 survivors. Researchers hope to use the technique to treat critically ill COVID-19 patients and boost the immune systems of health care providers and first responders.

"There is so much to be learned about this disease while it's occurring," said Dr. Marc Boom, Houston Methodist's president and chief executive officer, in a statement shared with the Houston Chronicle. 

"If an infusion of convalescent serum can help save the life of a critically ill patient, then applying the full resources of our blood bank, our expert faculty, and our academic medical center is incredibly worthwhile and important to do."

People who have fully recovered from COVID-19 for at least 2-weeks are encouraged to consider donating plasma, which could potentially help save the lives of up to four patients. Those willing to donate are urged to visit the American Red Cross website.

The FDA is an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

COVID-19 treatment news published by Precision Vaccinations.