Penn State Health using plasma from recovered patients as possible treatment for COVID-19
Penn State Health has enrolled its first COVID-19 patient into an experimental treatment program called convalescent plasma therapy, it announced Friday.
Access to this treatment is available through an expanded access program led by Mayo Clinic and coordinated by the U.S. Food and Drug Administration, Penn State Health said in a press release. Patients at both Penn State Health hospitals are being screened for eligibility to receive this experimental treatment.
This announcement came a day after Milton S. Hershey Medical Center announced it has begun enrolling participants in an international clinical trial evaluating an investigational antiviral drug, remdesivir, for treatment of coronavirus disease 2019 (COVID-19), one of 75 sites worldwide to participate.
Convalescent plasma therapy involves giving patients an infusion of plasma — the liquid portion of the blood — from people who have recovered from an infection with SARS-CoV-2, the virus that causes COVID-19.
“Plasma contains antibodies that may help patients being treated for COVID-19 recover,” said Dr. Melissa George, interim chairwoman of pathology at Penn State Health Milton S. Hershey Medical Center. “Those antibodies may give a patient’s immune system a boost until they can develop their own immune response.”
An expanded access program allows access to certain investigational new drugs or therapies, like convalescent plasma, and is made available outside of clinical trials, the press release said. The focus is to provide treatment whereas a clinical trial is focused on research and may involve a patient not receiving the treatment being studied.
Just like a clinical research trial, patient participation is optional and they must provide informed consent.
“Convalescent plasma therapy gives frontline providers another tool that may potentially aid in the treatment of critically ill COVID-19 patients,” said Dr. Thomas Ma, professor and chairman of the Department of Medicine at Penn State College of Medicine.
Dr. Edward Gunther, a professor of medicine at Penn State College of Medicine and a researcher at Penn State Cancer Institute, is overseeing the program and has been working with physicians to identify COVID-19 positive patients who may be eligible to participate. He works closely with Dr. Karen Krok, who oversees the clinical aspects of requesting and delivering convalescent plasma for eligible COVID-19 patients, and Dr. Jennifer Kraschnewski, who is offering research support to the team.
In addition, Penn State University is a member of the National Center for Advancing Translational Sciences’ Trial Innovation Network through the Penn State Clinical and Translational Science Institute and is reviewing investigational research opportunities for the use of convalescent plasma to treat or prevent COVID-19.
“At first we will offer this treatment to patients with severe or life-threatening COVID-19,” Gunther said. “As more patients around the country recover and access to plasma from those who have recovered increases, we hope to expand the treatment to all patients hospitalized with COVID-19.”
Eligible participants must be at least 17 years of age or older with a laboratory-confirmed diagnosis of infection with SARS-CoV-2, the virus that causes COVID-19. Patients hospitalized at the Milton S. Hershey Medical Center and Penn State Health St. Joseph Medical Center will have access to this treatment.
The concept of using blood from recovered patients to treat ill patients has been around for almost a century, according to the press release. During recent global outbreaks, researchers investigated this approach in the coronaviruses that caused severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Convalescent plasma had positive effects against these coronaviruses as well as against H1N1 influenza, but it was not effective against Ebola, which is a different type of virus.
Two small research studies conducted in China early this year show that convalescent plasma may help patients recover from COVID-19. Some of those patients were also treated with other experimental drugs, like antivirals — making it hard for medical experts to understand the precise effect of convalescent plasma in their recovery. Based on current knowledge, the FDA has not been able to say whether convalescent plasma will be an effective treatment against COVID-19, according to Penn State Health. While plasma transfusions are generally considered safe for most patients, the risks of convalescent plasma in the context of COVID-19 are not known.
Potential donors who have a positive test result for SARS-CoV-2 and have been symptom-free for 14 days can register with the Red Cross. Due to low availability of testing, it may be up to 28 symptom-free days for a sample to be collected in the absence of a confirmed negative test.
Penn State Health patients who may be eligible to donate their plasma towards this effort are being contacted by medical and nurse practitioner students from Penn State College of Medicine and Penn State College of Nursing.