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)? Will My Hospital Receive All of the Plasma from Donors I Refer to LifeStream?
No, please DO NOT refer family members to LifeStream to donate plasma exclusively for their loved ones.LifeStream does NOT provide directed donations to specific facilities or patients. The process of “directed donation” (collecting plasma from a specific donor for use by a specific patient), is much more difficult and time-consuming than collection from the overall group of recovered COVID-19 patients. Given the massive recent increase in demand for CCP in our region and across the US, we are working urgently to increase the overall supply of this product for ALL patients.