ChristianaCare joins FDA national program for convalescent plasma
ChristianaCare treated its first hospitalized COVID-19 patient with plasma donated by individuals who have recovered from COVID-19, the health system announced April 23.
ChristianaCare is partnering with the Blood Bank of Delmarva in the Food and Drug Administration’s national Expanded Access Program for convalescent plasma as a treatment protocol for COVID-19. ChristianaCare is one of more than 1,600 health care institutions across the U.S. registered in the program under the leadership of the Mayo Clinic.
Convalescent plasma is collected from individuals who have recovered from the virus, and it is administered to patients with COVID-19 who are at high risk of progression to a severe or life-threatening stage of the disease. Antibodies present in blood plasma of patients who have fully recovered are known to help fight infection. Over the past century, convalescent plasma has been safely collected and used at various times to treat polio, measles, hepatitis B, influenza, Ebola and other pathogens.
Qualifying donors are people who previously tested positive for COVID-19, but have fully recovered and remain symptom free for 14 days or longer.
“In our continuing effort to provide the highest level of care to our community during this pandemic, ChristianaCare is facilitating access to investigational convalescent plasma by participating in the National Expanded Access Treatment Protocol,” said Infection Disease Specialist Alfred Bacon, medical director of clinical trials at the ChristianaCare Medical Group and principal investigator of the study. “We are working closely with the Blood Bank of Delmarva in the collection of blood plasma so it is available in our hospitals and are looking to bring new patients into the program if they are appropriate for the treatment. A key to the success of this program is recovered patients willing to donate their plasma.”
Before donated blood can be used, it is tested for safety. Then it goes through a process to separate the blood cells so that all that is left is the plasma with the antibodies. A single plasma donation has the potential to help up to four patients with COVID-19.
An Expanded Access Program under the FDA is the mechanism by which access to certain investigational new drugs or treatments are made available outside of clinical trials. The focus of an EAP is to provide treatment, whereas a clinical trial is focused on research.
Initial data available from studies using COVID-19 convalescent plasma indicate that a single infusion of plasma has shown benefit for some patients. It is not known if this treatment will or will not help those with COVID-19 or if it will have any harmful effects, but this is one of a few promising treatments that we have at present. This program also will help researchers collect important information on patients who received the treatment.
Those who have recovered from COVID-19 — 14 days symptom free — are encouraged to register at delmarvablood.org.
For more on convalescent plasma for the treatment of patients with COVID-19, visit uscovidplasma.org.