Convalescent Plasma - Information for Health Care Providers
Delivering convalescent plasma (CP), a potential life-saving therapy for COVID-19, is an urgent priority for Blood Bank of Delmarva.
The FDA allows for three mechanisms in which hospitals can transfuse investigational convalescent plasma:
- Hospitals can pursue an Expanded Access Protocol (EAP) through the Mayo Clinic (details below)
- Hospitals can use a Single Patient Emergency Investigational New Drug (eIND) application (details below)
- Hospitals are performing clinical trials through the traditional IND pathway. These clinical trials are investigating its use in expanded populations, including prophylactic use, use in mild to moderately ill patients, as well as severe and critically ill patients.
Expanded Access Protocol (EAP)
The Mayo Clinic EAP protocol is open to all hospitals and is supported by the FDA and Biomedical Advanced Research and Development Authority (BARDA). Hospitals must register their institution. Hospitals do not need to file an IRB at their institution. Each patient must be enrolled using their website.
Patients are eligible for this protocol if:
- They are 18+ years of age
- They have laboratory-confirmed diagnosis of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19
- They are admitted to an acute care facility for the treatment of COVID-19 complications
- They have severe or life-threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease
- There is informed consent provided by the patient or healthcare proxy
- Register the hospital, not the health system (registration form)
- Each physician acting as the treating physician registers (registration form)
- Each participating patient must be registered by their treating physician (registration form)
- The physician receives confirmation of enrollment.
- Request the product through your Blood Bank Medical Director. See below for information on How to Order Convalescent Plasma through BBD.
- Complete the 4-hour post-transfusion form.
For more information, visit uscovidplasma.org.
Single Patient Emergency Investigational New Drug (eIND)
The single patient eIND allows for treating a patient, including children, with serious or immediately life-threatening COVID-19 infections.
FDA approval should be requested by the patient’s physician prior to transfusing products. Hospitals using the eIND should evaluate if they need to obtain an institutional IRB and if they need to require informed consent prior to treatment.
BARDA funding does not extend to the eIND protocol.
Registration: Hospitals can request eIND through this link Recommendations for Investigational COVID-19 Convalescent Plasma.
How to Order Convalescent Plasma
- An interested physician must first make contact with their Blood Bank Medical Director as this product is ordered like other blood products.
- In order to transfuse the convalescent plasma, a hospital must participate in one of the IND mechanisms outlined above in order to obtain the COVID-19 convalescent plasma from a blood center.
- BBD contractual customers can order product directly from BBD by going to BloodHub. While we build an inventory of CP, only order for patient specific need, not for inventory/stock.
- Non-contractual customers, please complete and submit this form and a blood bank representative will be in touch shortly.
- Convalescent Plasma ISBT Labels (PDF)
- ISBT Codes - please enter the following product codes into your system
|Product Description||Product Code|
|Apheresis CONVALESCENT PLASMA|ACD-A/XX/||E9747V00|
E9747VA0, E9747VB0, E9747VC0, E9747D0
|Thawed Apheresis CONVALESCENT PLASMA|ACD-A/XX/refg|COVID-19||E9752|
BBD has greatly expanded our capacity to collect and are rapidly building our public inventory to meet patients’ needs. If you or someone you know would like to donate convalescent plasma, the potential donor needs to be:
- Known test positive - this can be through nasophargeal swab PCR positive or through clinical history consistent with diagnosis and laboratory evidence of SARS-CoV-2 antibodies
- Be at least 14 days symptom free
- Be eligible to donate blood - visit Donor Eligibility for more information
- Donors can register on our website at delmarvablood.org/cpdonor