COVID-19 Convalescent Plasma Program
Last updated: September 4, 2020
Click here for answers to questions about the FDA Emergency Use Authorization of CCP
What is Investigational COVID-19 Convalescent Plasma?
Patients who have recovered from COVID-19 may have immune-boosting antibodies in their plasma; that plasma—called “COVID-19 convalescent plasma”—could be used to treat critically ill COVID-19 patients. The treatment is not proven but may have some impact in preliminary studies.
LifeStream is Accepting Convalescent Plasma Donations
We have been working rapidly and judiciously with our industry partners and the FDA to establish our convalescent plasma collection program. We are now ready to accept information from donors and hospitals wishing to refer donors. See below to determine your next step.
COVID-19 Convalescent Plasma donations can ONLY come from donors who have fully recovered from a confirmed COVID-19 infection AND have successfully completed an eligibility process in cooperation with their physician and LifeStream Blood Bank’s Medical Services team. If you believe you are eligible to donate COVID-19 Convalescent Plasma, please click below or call 909-386-6837.
Click the Button That Best Describes You for Next Steps:
- LifeStream does not test donors or blood products for ACTIVE COVID-19 infection.
- LifeStream Blood Bank is now testing all successful blood donations for COVID-19 antibodies. Your antibody testing results reveal your potential to donate convalescent plasma, a powerful way to help those fighting COVID-19. The antibody test will indicate if the donor’s immune system has produced antibodies because of previous exposure to the virus. This is not a test that tells a person whether or not they have a current COVID-19 infection. If you are feeling unwell, please do not donate blood. For more info about antibody testing, click here.
- LifeStream does NOT provide directed donations to specific facilities or patients. When a donor donates convalescent plasma on behalf of a hospital, we reserve some of the products from that collection for that hospital’s use. The hospital then decides how to distribute the product in their facility, based on their own criteria. We work with donors and hospitals to make this happen every day through this web page, and we are appealing to recovered COVID-19 patients throughout our area to contact us to arrange a convalescent plasma donation.
For further questions, please email covidplasma@LStream.org, or call (909) 386-6837.
An update on the FDA’s Emergency Use Authorization for convalescent plasma
On August 23, 2020, President Trump and Dr. Stephen Hahn (FDA Commissioner) announced Emergency Use Approval for COVID-19 Convalescent Plasma (CCP), and the FDA followed this with formal guidance on September 2, 2020. Here is an update from D. Joe Chaffin, MD, LifeStream Chief Medical Officer:
Q: What does “emergency use authorization” of CCP mean?
A: FDA granting CCP EUA status simply means that physicians can now order and transfuse CCP without needing to formally enroll their patient in a research study. The vast majority of CCP units transfused prior to September 1 were performed under the “Expanded Access Protocol” (EAP) sponsored by the Mayo Clinic, which is now closed. Patients may still receive CCP under individual clinical trials as well as through single patient emergency “investigational new drug” requests submitted directly to FDA but we expect most units will now be requested under the EUA.
Q: Is the Mayo Expanded Access Protocol (EAP) closed?
A: Yes. The Mayo EAP closed to new enrollments on August 28, 2020, and closed to further CCP transfusions at midnight on August 31, 2020 For more info, click here.
Q: If I can’t get CCP through the EAP and my hospital doesn’t have our own research protocol, what do I do? Can I still order the product?
A: Yes, absolutely, though each hospital should discuss this issue internally. The EUA allows hospitals to transfuse CCP based on clinician judgment, without a research protocol. Hospitals must decide internally on their best practices for informed consent practices (see later question on this issue below).
Q: Do I still call LifeStream and order CCP in the same way?
A: Yes, please continue ordering in the same way until further notice. LifeStream staff will continue to ask you for the patient name and blood type. We will update you when and if the ordering process changes.
Q: Is the CCP LifeStream provides “high-titer” or “low-titer?”
A: The EUA includes the requirement to label CCP units as containing a “high titer” or “low titer” of anti-SARS-CoV-2 antibodies. While LifeStream tests ALL units of CCP and confirms the presence of antibodies, our current units are not labeled with anti-SARS-CoV-2 antibody titers. While we expect that at least half of our CCP products will ultimately qualify as “high titer” units, we cannot currently make that claim under the specific terms of the EUA. FDA specifically addresses this issue in the guidance mentioned above and has allowed the continued use of CCP units not labeled with titer results during a 90-day “transition period” that ends on December 1, 2020. We hope to be able to update you soon.
Q: Do hospital transfusion services and clinicians need to do anything differently when transfusing CCP to patients under the EUA?
A: Yes, and those requirements are very important for hospital transfusion services and clinicians to recognize and implement. As part of the EUA, FDA requires that clinicians be provided with a fact sheet on CCP, and that all recipients receive a different fact sheet. The fact sheet distribution is a local hospital responsibility. Hospitals should carefully evaluate both the EUA and the fact sheets to determine your best protocols for informed consent and other processes related to CCP transfusion.
IMPORTANT NOTE: As mentioned above, barring amendments to the EUA, most of the CCP that will be transfused before December 1, 2020 will be plasma that is not labeled as “high-titer” or “low-titer.” As a result, the fact sheets will not be fully consistent with the product that is being transfused. FDA addresses this issue specifically in the Guidance document, stating that the fact sheets may be used for discussion in these instances, and that such practice is acceptable if:
- “The treating health care provider obtains adequate informed consent from the patient or his or her legally authorized representative for the use of the investigational convalescent plasma. Informed consent should include, at a minimum, a statement that the use of convalescent plasma is investigational and a discussion of its potential risks and benefits.” (United States Food and Drug Administration. “Investigational COVID-19 Convalescent Plasma: Guidance for Industry,” September 2020; page 12)
Q: Does the emergency use approval mean that CCP’s benefits are now proven?
A: According to the FDA, EUA’s are granted when it is “reasonable to believe that known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product.” This does NOT imply that the benefits of CCP are proven, despite what may be said publicly. In fact, the FDA’s actual CCP EUA document explicitly states the following: “No descriptive printed matter, including advertising or promotional material, relating to the use of COVID-19 convalescent plasma may represent or suggest that such product is safe or effective” (page 6; emphasis added).
Q: How will billing for CCP change now that most patients are not being transfused under research protocols?
A: On August 28, 2020, LifeStream sent a memo to all partner hospitals electronically and by regular mail outlining billing changes. At that time, we did not know if BARDA funding for CCP would continue beyond the Mayo EAP or not. We have since learned that it will be continued for some period of time but we do not know if that will be for the full 90 day transition period or not. We will let you know when we have more information. Currently, with continued BARDA funding, there will be no charge for CCP units. Please refer to that document for more details.
Q: Should we still encourage recovered COVID-19 patients to donate CCP?
A: A resounding “YES!” LifeStream receives requests for CCP from hospitals all across Southern California every day of the week. It is likely that the need for “high titer” CCP donors will increase, as the EUA is very likely to increase demand for this product. Please refer recovered COVID-19 patients to this web site or to call 909-486-6837.