FDA approves first plasma therapy for Houston Methodist COVID-19 patients

Houston Methodist, FDA-approved on Saturday, became the country’s first academic medical center to transduce plasma from donated COVID-19 patients to critically ill patients. COVID-19 pandemic deaths soared to more than 2,000 people nationwide, and more than 100,000 Americans were affected by the virus.

Houston Methodist physician scientists began recruiting plasma donors on Friday from about 250 patients diagnosed with a positive COVID-19 virus at a Houston Methodist hospital. The donors were glad to be immediately identified, and each donor gave 1 quart of plasma in a procedure that provided whole blood. Human plasma recovered from COVID-19 contains antibodies made by the immune system and used to kill the virus. Transfusing this antibody-rich plasma into COVID-19 patients (patients still struggling with the virus) can heal the power of the antibody and potentially shift to life-saving treatments.

The first recovered COVID-19 patient who donated plasma was an individual in the Houston metropolitan area who has been in good health for more than two weeks. Plasma was transfused to a COVID-19 patient Saturday night at Houston Methodist Hospital

This concept, known as convalescent serotherapy, is a similar treatment during the 1918 Spanish flu pandemic, the 1920s diphtheria outbreak, the 1930s carnivorous bacterial outbreak, and other outbreaks. Dating more than a century before the law was used. Infection. Although there is much literature on the theory that convalescent plasma can be used to transfer immunity from healthy to sick people, results have varied. An explanation of the treatment of five patients in China this week, American Medical Association Journal, Suggesting that the treatment was beneficial.

“I feel here that Houston Methodists have the competence, expertise and patient base of their healthcare system and are obliged to try this treatment,” said Mark Boom, Houston Methodist President and CEO.

“There is a lot to learn about the disease while it is happening,” he said. “If infusion of convalescent serum can help save lives in critically ill patients, it is incredible to utilize all the resources of our blood bank, our experts, and our academic medical centers It’s worth it and it’s important to do it. “

Recruitment of the Houston Methodist began as soon as the FDA published research regulatory guidelines earlier last week. A Houston Methodist physician scientist designed and validated a COVID-19 molecular test two months ago, and was ready to begin collecting data when COVID-19 patients began to arrive. The Houston Methodist IRB and regulator experts reviewed the treatment protocol quickly and secured FDA approval this weekend.

Earlier this week in New York City, Governor Andrew Cuomo announced that recruiting patients for plasma donations would start in a few days, initially focusing on the blockbuster New York City suburb of New Rochelle, New York.

Eric Salazar, MD, a principal researcher and physician scientist at the Pathology and Genomics Division at Houston Methodist Hospital and Research Institute, said that patients meet the criteria for donating plasma, according to a review of the chart for COVID-19 patients maybe. Patients with serious underlying illnesses and the elderly are not eligible for donations.

Under the FDA guidelines, Houston Methodist convalescent serotherapy treatment is categorized as an Emerging Investigational New Drug Protocol (eIND) that requires FDA approval for each patient who has been injected with donated convalescent sera. Houston Methodist physician scientists seek follow-up studies, possibly additional FDA approval of multicenter national trials on the efficacy of convalescent serotherapy against the COVID-19 virus.

The process of providing blood plasma is similar to the process of providing blood and takes about an hour. The plasma donor is connected to a small device that removes the plasma and at the same time returns the red blood cells to the body. Unlike regular blood donations, where donors have to wait for red blood cells to replenish during donations, plasma More often, you can donate about twice a week.

“Unfortunately, convalescent serum therapy can be an important treatment. Unfortunately, there is relatively little that can be offered to many patients except for supportive care, and ongoing clinical trials may take some time. And it doesn’t take much time. ”