MUSC Health provides plasma transfusion to COVID-19 patients, participates in national rapid access program

Four critically ill COVID-19 patients were successfully infused with convalescent plasma by MUSC Health physicians as part of an investigational treatment to improve their symptoms and help them to recover after contacting the deadly coronavirus. Three patients at MUSC Health University Medical Center in Charleston and one patient at MUSC Health Lancaster Medical Center are the latest patients to participate in this FDA-sponsored program, which involves MUSC physicians and investigators and support from blood centers to collect and distribute plasma from compatible donors who have fully recovered from COVID-19. 

COVID-19 is the illness caused by the coronavirus, known as SARS-CoV-2. With vaccines and therapies still being tested to fight the virus, convalescent plasma has gained new prominence as a promising therapy especially in treating patients suffering from complications of the virus. In announcing this program, MUSC physicians are encouraging people who have recovered from COVID-19 to donate plasma. This includes those who were previously diagnosed and confirmed with a test through MUSC Virtual Urgent Care and are now 28 days symptom-free. These recovered patients have developed antibodies against the virus, and their plasma donation can potentially save the lives of up to four patients.

Plasma is the liquid in blood that contains antibodies made by the body’s immune system to attack viruses. A recovered COVID-19 patient’s plasma can be transfused into a current COVID-19 patient and might provide some relief for the patient during the course of the disease or reduce complications.

 

In an effort to approach this most methodically, MUSC has joined Mayo Clinic’s Expanded Access Program (EAP) to provide convalescent plasma to patients who are severely suffering from COVID-19. The protocol requires patients to consent to receiving convalescent plasma from a donor who has recovered from COVID-19. Working under Mayo Clinic’s industrial review board protocol, only hospitalized COVID-19 patients who are referred by a health care provider and meet certain criteria can participate in this program.

In South Carolina, MUSC joins Prisma Health, Tidelands Health and Roper-St. Francis as participants in this plasma treatment program. MUSC’s involvement is part of a multidisciplinary effort led by John Wrangle, M.D., assistant professor in the Department of Medicine’s Division of Hematology and Oncology. Wrangle has worked closely with pulmonologists and those physicians on the frontline of care, researchers and regulatory experts, telemedicine staff and other specialists to establish this program quickly.

“By joining in Mayo Clinic’s Expanded Access Protocol (EAP), MUSC is responding to the national challenge of fighting COVID-19 by facilitating access to convalescent plasma treatment to make this potential disease-modifying therapy available to physicians and South Carolina’s most vulnerable COVID-19 patients in need,” said Kathleen Brady, M.D., Ph.D., vice president for research and director of the South Carolina Clinical & Translational Research Institute and Distinguished University Professor. “I’m proud of the quick response and dedication provided by our research and regulatory teams who are working collaboratively with clinicians, specialists and other experts who are leading this effort.”

Wrangle is also working with Robert Rainer, M.D., medical director of the Blood Connection and a blood bank pathologist at Prisma Health, to help to organize and collect plasma products and bring convalescent plasma therapy to South Carolina communities. The Lowcountry American Red Cross is also assisting in blood plasma collections for this FDA-authorized treatment. 

 

MUSC, participating EAP hospitals and blood centers are in a race against time to identify, collect and store convalescent plasma from recovered coronavirus patients from around the Palmetto state. 

The epicenter of the coronavirus infection in South Carolina was identified in Kershaw County around mid-March. Since that time, MUSC has been at the forefront of numerous efforts to combat the virus, including gearing up to deploy convalescent plasma. As of April 17, Rainer had identified 80 COVID-19 recovered patients and recruited 10 people to donate plasma for this protocol. Both Wrangle and Rainer expect these donor numbers to grow as more patients recover from COVID-19 around the state – making them eligible to donate their antibody-rich plasma. 

“There’s reason to believe that this may be an effective therapy for COVID-19 patients,” said Wrangle. “We feel that ensuring an opportunity for people to recover from this infection and donate is critical to creating a vast supply or inventory of plasma so that anyone in the state can draw from it when needed.”

Through its Center for Telehealth, MUSC Health quickly established a systematic process to identify the potential blood plasma donors who would be asked to consider plasma donation. Before making their decisions, patients would be able to speak directly with MUSC Health physicians who could answer their questions about the process and explain the value of donating their plasma as a way to help to treat critically ill COVID-19 patients. 

Wrangle explained that key to MUSC’s process is everyone’s dedication to a patient-focused mission. To that end, Wrangle established a one-to-one outreach protocol, arranging for MUSC Health physicians to make phone calls to documented coronavirus patients. He said this level of communication has gone a long way in helping patients to understand the value of this experimental plasma treatment and how blood from COVID-19 survivors can help neutralize the virus and give patients a fighting chance against the disease. 

Expanded Access Program

The program is growing. As of mid-April, more than 1,902 hospitals, government agencies and medical institutions, which, in addition to MUSC, include Johns Hopkins University, Washington University, Einstein Medical Center, had registered as participants in the U.S. COVID-19 EAP with 2,900 physicians and almost 1,000 patients enrolled. As of April 23, the program had successfully infused 1,458 COVID-19 patients nationwide.

So far, outreach efforts have paid off. As of April 22, six patients have donated their plasma with several dozen people scheduled to donate before the end of the month. 

“Working with MUSC’s team has been a great experience,” said Rainer, who is a 1988 MUSC College of Medicine alumnus. “Dr. Wrangle, everyone, worked pretty quickly and efficiently to get the EAP program up in a timely manner. Everyone has been very professional, and we have great people involved in this effort.”

According to Rainer, collecting convalescent plasma for this study is no different than collecting blood and plasma products from donors. The plasma undergoes testing and screening for disease prior to its availability to hospitals and acute care facilities for medical therapy. One difference is that the plasma product is labeled as coming from a convalescent donor. 

The process of donating plasma is similar to giving blood. First a needle is placed in the vein of a donor’s arm. Plasma is collected and cycles through a machine where the plasma, a rich, yellow liquid is separated and collected in a process called plasmapheresis. The red blood cells are returned back to the donor. The process can take up to two hours for first time plasma donors. 

As with a standard blood donation, patients and donors must be matched by blood type. Plasma can be frozen and stored for a year and still be effective, according to Rainer. 

MUSC Health CEO Patrick J. Cawley, M.D., praised clinicians and researchers for their efforts to work together to introduce this treatment as a clinical benefit to patients affected by this disease. 

“Providing this centuries-old, yet still pioneering, treatment enables MUSC Health to treat our most critically ill COVID-19 patients with antibody-rich plasma that our recovered patients developed to fight the virus. This will allow the immune systems of our sickest patients an opportunity to ramp and fight the virus. I could not be prouder of our MUSC Health care team, in collaboration with our MUSC researchers, for working so hard to bring this and numerous other inventive options to fruition,” Cawley said. “As the state’s only academic health sciences center, we must perpetually think outside the box in terms of ways in which we can substantially and rapidly help the community and state during this unprecedented time.”  

People who are interested in donating plasma should check with their health care providers (physicians who ordered their COVID-19 RNA tests) who will refer them to the Blood Connection to arrange for a blood plasma donation. Every donation is important.  

A convalescent plasma therapy Q&A with John Wrangle, M.D.

What is convalescent plasma therapy?

Convalescent plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19. Patients who recover from infection develop antibodies or proteins that stay in the plasma that may be able to help sick patients fight the virus that causes the illness. 

Why is MUSC involved, and what protocols must be followed?

The U.S. Food and Drug Administration (FDA) asked Mayo Clinic to serve as the central Institutional Review Board for the U.S. Expanded Access Program (EAP). The EAP is the mechanism to access certain investigational new drugs made available outside of clinical trials. The EAP focuses on providing treatment, whereas a clinical trial is focused on research. An EAP is sometimes necessary when the presence of a disease is classified as life threatening or severe and there is no current intervention available. The FDA and Mayo Clinic have streamlined the program with participating hospitals and medical centers, to enroll patients, and agree to rely on Mayo Clinic’s IRB protocol and regulations.

How does it work?
People interested in donating plasma must have been confirmed by a test that they were infected with COVID-19 and must be 28 days without symptoms. Patients meeting these criteria should obtain a copy of their test results and contact the Blood Connection – (854) 429-1700 – to schedule an appointment to donate plasma. Donors must be at least 18 years old. This plasma is then available to physicians treating patients ill with the COVID-19 virus.

What happens after a patient receives the plasma product?

Once the approved plasma product is administered to the patient, MUSC Health’s care team and protocol physicians will continue to monitor the patient for any serious reactions or adverse events related to the convalescent plasma infusion.

Does the EAP provide antibody testing?

The Expanded Access Program is not directly involved in serologic testing to identify people with COVID-19 exposure. If you are interested in obtaining serologic testing, the test would need to be ordered by your local primary care provider when these tests become available. 

How can I donate convalescent plasma?

There are several local and statewide resources to donate convalescent plasma in South Carolina, including the Blood Connection North Charleston and the Lowcountry S.C. Chapter of the American Red Cross. The Blood Connection can be contacted at (854) 429-1700.

Can I direct my convalescent plasma donation to a person of my choosing?

To ensure compatibility with blood type and the requirement to adhere to strict guidelines in this treatment program, directed donations are not permitted.

If I am cleared to donate, what can I do prior to donating plasma?

Hydrate well before your visit. Drink water or other clear nonalcoholic fluids. This can help prevent dizziness, fainting and fatigue.

When can I donate convalescent plasma?

It’s recommended that donors donate two weeks (14 days) after their original convalescent plasma donations.