Convalescent Plasma - FAQ for Health Care Providers
What is COVID convalescent plasma (CCP)?
CCP is plasma collected from people who have recovered from COVID-19 infection. CCP is contains antibodies that can neutralize SARS-CoV-2 and thus improve disease course in patients with COVID-19 infection. At NYBC, people who had documented SARS-CoV-2 infection can donate CCP once they have been free of COVID-19 related symptoms for a minimum of 14 days. CCP donors must also meet all standard allogeneic blood donor criteria. CCP is collected by plasmapheresis and the plasma apportioned into units of approximately 200 mL.
Is CCP safe?
Preliminary studies report no adverse events specific to CCP. CCP donors must meet all standard allogeneic blood donor eligibility criteria and test negative for all relevant transfusion-transmitted infectious diseases. Also, the same transfusion related acute lung injury (TRALI) risk mitigation strategies implemented with standard plasma donation also apply to CP donors.
Is CCP effective?
Preliminary evidence suggests potential improvement in respiratory status, inflammatory markers, and viral load in COVID-19 infected patients receiving CCP. Neutralizing antibody titers to SARS-CoV-2 increased in some patients.
Is my patient appropriate for CCP?
For the Mayo Clinic expanded access and single patient emergency IND protocols (see below), eligible subjects must be adults (18+ years of age) hospitalized for laboratory-confirmed SARS-CoV-2. They must have COVID-19 that is severe or life-threatening, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease. Definitions for severe and life-threatening disease can be found at uscovidplasma.org. Additionally, a number of clinical trials are available for children, patients with mild or moderate disease, and individuals with high risk exposures but not yet infected.(https://ccpp19.org/healthcare_providers/component_3/index.html).
How can I obtain CCP for my patient?
There are three pathways to obtain CCP:
- NYBC recommends that hospitals and their prescribing physicians register with the National Expanded Access Treatment Protocol through the Mayo Clinic at uscovidplasma.org. A Patient Enrollment Form and informed consent must be completed for each patient. Instructions can also be found on the NYBC website at nybc.org/covidplasma.
- The second pathway is to obtain a single patient emergency IND for each patient from the FDA. Instructions for this option can be found on the FDA website.
- The third pathway is for your institution to participate in one of the clinical trials. More information for this option can be found on the National COVID-19 Convalescent Plasma Project website.
I have enrolled my patient. How do I order the CCP product from NYBC?
If your hospital already has a contract to receive blood from NYBC, your blood bank simply needs to place an order through our online ordering system, BloodHub.
If your hospital does not have a contract to receive blood from NYBC, please have your blood bank supervisor complete our customer inquiry form. A member of the customer service team will then contact your blood bank to enable your hospital to order and receive CCP.
How can our hospital differentiate a CCP product from a regular plasma unit?
Products are labeled as “CONVALESCENT PLASMA” and “Anti-SARS-CoV-2 Immune Plasma”. Your hospital blood bank must enter the proper product ISBT codes into their blood bank software system. For more information, visit Information for Health Care Providers.
Do CCP products need to be ABO compatible with the patient?
On the expanded access protocol, products are required to be ABO-compatible. On eINDs, ABO-compatibility is not required, but NYBC recommends that ABO-compatible units be administered.
How many CCP products can I order for my patient?
On the expanded access protocol, one or two units of ABO-compatible CCP can be transfused. On eINDs, the treatment plan must be specified in your submission (Form FDA 3926), but the typical dose is one or two units.
Can a patient’s family member do a directed CCP donation to my patient?
No, NYBC is not doing directed donations. CCP requests are filled from our inventory of CCP. Interested donors can register on our website at nybc.org/cpdonor.
Are CP donor products released to hospitals before confirmation that their antibody test is positive?
No, NYBCe screens each CCP donation for the presence of antibodies prior to releasing to hospitals.