COVID-19 Convalescent Plasma Program – Hospitals
Last updated: September 4, 2020
The FDA’s release of an Emergency Use Authorization for COVID-19 Convalescent Plasma (CCP) has led to new requirements for hospitals and clinicians. Further, there is a transition period that ends December 1, 2020 during which both “investigational” and “EUA” convalescent plasma are acceptable for use.
Pathways to Obtaining CCP:
- Emergency Use Authorization (EUA) from FDA
- Hospitals should carefully review the EUA, download the required fact sheet for clinicians and patients, and develop internal policies and protocols for CCP transfusion.
- This pathway does not require a research protocol (or “IND”), but there are internal requirements regarding informed consent and distribution of the fact sheets that must be met.
- Emergency Investigational New Drug Approval (eIND from FDA)
- Approval to administer CCP under an eIND is patient specific (Each patient undergoing treatment requires an individual approval from FDA).
- The basic process is outlined here.
- Local (independent) Investigational Review Board Research Protocol (IND)
- You will need to follow your own approved IRB processes for transfusion of this product.
- Any additional tests or samples for donors referred by a hospital to LifeStream will be the responsibility of the hospital (LifeStream will not collect additional samples for your research use, in other words).
NOTE: The “Expanded Access Protocol” from Mayo Clinic has been discontinued.
To prepare for program expansion and accepting convalescent plasma at your organization, please enter the following ISBT codes into your system as soon as possible:
Ordering COVID-19 Convalescent Plasma
Please contact LifeStream Hospital Services at 909-386-6829 or email covidplasma@LStream.org for more information. This product will not be available through routine electronic ordering system.
Does LifeStream Test CCP Donors for the SARS-CoV-2 Virus Itself?
There is no approved test to detect actual SARS-CoV-2 virus in blood, and such testing is not required. As a result, LifeStream does not test CCP donors for active COVID-19 infection. CCP donors are screened according to FDA criteria, and are confirmed to be recovered from a symptomatic COVID-19 infection, and they must also meet all usual requirements for blood donation. All CCP donors are tested for the presence of antibodies against SARS-CoV-2 as a condition of release of the product.
Does LifeStream Support Directed Donations of CCP (from one family member to another, for example)?
No, LifeStream does not support directed CCP donations. When a donor donates CCP on behalf of a hospital, we reserve some of the products from the first donation for that hospital’s use (see below). The hospital then decides how to allocate the product. The very large donor response to the appeal to donate CCP makes “special” donations like directed donations impossible at this time.
Will My Hospital Receive All of the Plasma from Donors I Refer to LifeStream?
- If LifeStream successfully collects a plasma product from a donor referred by a hospital or provider associated with a hospital, we will reserve up to half of the plasma products collected from the donor’s first donation for that hospital’s use.
- Most apheresis plasma collections result in three or four plasma units, approximately 200 mL each. If up to three units are collected from the donor’s first donation, one unit will be reserved for the referring hospital. If four units are collected, then two units will be reserved.
- Please note: This process is NOT a “directed donation.” LifeStream will not “tag” the unit with a potential recipient’s name, as this is the responsibility of the transfusing facility. ABO compatibility is also the responsibility of the transfusing facility.