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: