As you are aware there is limited research concerning the effectiveness of Convalescent Plasma to treat COVID-19. However, the data that is available is encouraging. Based on recent experience we believe suitable plasma donors will be in short supply. The blood center encourages hospitals to identify and refer donors to the blood center for screening to be Convalescent Plasma donors.
In order to take advantage of this product each facility will need to have an approved IND on file with the FDA. For facilities expecting relatively few patients an eIND might be sufficient. This form needs to be completed for each patient.
For facilities expecting a higher volume of patients it may be worthwhile to pursue the following Mayo Clinic sponsored IND.
Link to Mayo Clinic Severe/Critical Study: https://www.uscovidplasma.org/#physicians
Ultimately, how your facility plans to manage this may depend on your institutional IRB if one is available. It is necessary to be participating in an IND in order to use this product.
Once the ordering physician has an eIND number or is enrolled in a multi-organizational IND, a request can be placed with the blood product provider.
Placing an Order with the Miller-Keystone Blood Center
Orders can be placed in BloodHub by choosing the product CFFP, Convalescent FFP, from the drop down menu.
Order CFFP separately from any other orders. This is so we can be sure that we are filling your CFFP order properly. Do not add this CFFP to an order that has other blood and blood product requests associated with it.
The product from Miller-Keystone Blood Center will be labeled and licensed as an automated fresh frozen plasma product, FFP or PF-24. A tie tag will distinguish it from other frozen plasma products. The tie tag will contain the following information:
Caution: New Drug – Limited by Federal (or United States) Law to Investigational Use
It is our hope this labeling process makes the product easy for you to manage in your computer system, as no new product codes need to be created or validated.
Miller-Keystone Blood Center recruits donors that are screened and qualified in every way to be volunteer, community blood donors. All donors having a history of tissue transplant, transfusion or pregnancy must have a negative for HLA antibody screen. All of the infectious disease tests are the same as for any other licensed red blood cell, platelet or plasma product issued by Miller-Keystone Blood Center. The only difference is the donor has been selected as having recovered from COVID-19 infection. The tie tag is the only thing identifying it as an investigational product.
Besides being eligible to be routine community blood donors, individuals must be able to show they were diagnosed with COVID-19 and free of symptoms due to COVID-19 for at least 28 days.
Link to Mayo Clinic Study: https://www.uscovidplasma.org/#physicians