FDA nod for first experimental plasma therapy for COVID-19 in the U.S.

By Angela Betsaida B. Laguipo, BSNMar 31 2020

The coronavirus disease (COVID-19) global pandemic has rapidly spread across the globe, now affecting 180 countries and territories. The United States is the front runner with the highest number of confirmed cases, surpassing both China, Italy, and Spain in the case toll. With the vast spread of the novel coronavirus, scientists and health experts are opting for varied treatments in the hope of helping ailing patients infected with COVID-19.

The U.S. Food and Drug Administration (FDA) issued the green light for Houston Methodist Hospital to use the plasma from a recovered patient to a critically ill patient admitted to the institution. The hospital is the first academic medical center in the country to use plasma therapy in treating patients with COVID-19. The treatment was 'fast-tracked' as the number of cases skyrocketed over the weekend, with more than 188,000 confirmed cases and the death toll topping 3,800.

What is plasma therapy?

Plasma therapy is endorsed by the World Health Organization (WHO) as a valid approach, wherein doctors infuse the plasma from a recovered patient to currently infected patients, to boost the latter's immune system to fight against the virus.

Doctors in China used plasma therapy to help critically ill patients to recover from the viral infection. Convalescent plasma has been proven effective in battling infectious diseases in the past. It was used during the Ebola outbreak in 2014.

In using plasma therapy, the hyperimmune globulin concentrates the antibodies in patients who have recovered from the disease. This provides the new patient's immune system a boost of antibodies so that they can fight the infection better.

Houston Methodist will set up a special area for recovered COVID-19 plasma donors to give their virus-fighting antibodies for the use of critically ill patients in a first-of-its kind study here. Image Credit: Houston Methodist

The process

Houston Methodist physician-scientists have started recruiting donations from survivors of COVID-19. An estimated 250 patients have tested positive for the coronavirus at Houston Methodist hospitals. The donors were identified, wherein about a quart of blood will be extracted from them. The first procedure commenced on Mar. 28. The doctors extracted the plasma from a recovered patient and transfused it into a COVID-19 patient.

"Here at Houston Methodist, we have the capability, the expertise and the patient base from our health care system, and we feel obligated to try this therapy," Marc Boom, Houston Methodist President, and CEO said.

"There is so much to be learned about this disease while it's occurring," he said. "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," he added.

The FDA approved the treatment on Mar. 28, classified as an emergency investigational new drug protocol. This way, the doctors can fast track the recruitment process and the procedures, potentially saving many lives.

"This is like a regular plasma donation, and so we the donors have to qualify to be regular plasma donors. We have to follow the procedures that you would normally follow for any plasma donation, and that includes matching blood types and testing the plasma for infectious agents," Dr. Eric Salazar, the principal investigator, and a physician-scientist at Houston Methodist explained.

He added that convalescent serum therapy could be an essential treatment option since there is still much to be learned about the coronavirus. At present, since there is no approved treatment for COVID-19, most doctors only provide supportive care. With the high number of cases and the increasing death toll, he said that they do not have much time.

Dr. Salazar also explained that it is too early to say if the plasma therapy is benefiting the patients. However, they are closely monitoring the patient to determine any improvements in his health status.

In New York, the worst-shaken state of the COVID-19 crisis started recruitment for plasma donations, according to Governor Andrew Cuomo. The therapy will mainly focus on the New York City suburb of New Rochelle, the epicenter of the COVID-19 pandemic in the United States.