Transfusion medicine

• COVID-19 convalescent plasma is an investigational blood product used to treat certain patients who are infected with the novel coronavirus
• FDA EUA has been modified multiple times, most recently December, 28, 2021; transfusion of CCP in hospitalized immunocompetent patients is not authorized due to lack of proven clinical benefit (FDA: Convalescent Plasma COVID-19 Letter of Authorization [Accessed 16 February 2023])
• EUA currently authorizes use of CCP with high titers of anti-SARS-CoV-2 antibodies for the treatment of COVID-19 patients with immunosuppressive disease or receiving immunosuppressive treatment either in the outpatient or inpatient setting (FDA: Investigational COVID-19 Convalescent Plasma [Accessed 16 February 2023])
• Donors must have evidence of COVID-19 infection, either with symptoms and a positive test by an FDA approved, cleared or authorized method or donors who have not had symptoms but test positive on 2 different tests approved, cleared or authorized by the FDA to test for SARS-CoV-2 antibodies
  • Donors must be eligible for blood donation, have been COVID symptom free for 10 days and be male, never pregnant female or female who has tested negative for HLA antibodies since her last pregnancy
  • Donors who have only had the vaccine are not eligible; donors who are vaccinated and have had SARS-CoV-2 are eligible if they have symptoms and test positive for SARS-CoV-2 and are within 6 months of infection
• Plasma donation must be tested for high titers of anti-SARS-CoV-2 antibodies using a test methodology approved, cleared or authorized by the FDA
• Recipients are eligible at the discretion of their healthcare provider, with documentation of consent in the patient's chart
• CCP carries the same risks as FFP or FP24: allergic transfusion reaction, transfusion related acute lung injury, transfusion associated circulatory overload, hemolytic transfusion reaction and infectious disease transmission; no risks specific to COVID-19 have been identified (J Clin Invest 2020;130:4791)

A potential candidate for convalescent plasma donation presents to the donor center. He has a history of a confirmed positive PCR for COVID-19 performed by nasopharyngeal swab. He had mild symptoms of cough, fever and fatigue, and states his last symptoms were 9 days ago. Is he eligible to proceed with donation?

1. No, he is not eligible because he also needs a COVID-19 antibody titer
2. No, he is not eligible because he needs a repeat PCR to prove he is negative for COVID-19
3. No, he is not eligible because he needs to be symptom free for 10 days
4. No, he is not eligible to donate until he has been symptom free for 28 days
5. Yes, he is eligible to donate

C. No, he is not eligible until he has been symptom free for 10 days. Eligibility for donation for COVID-19 convalescent plasma (CCP) requires 1) confirmation of disease by either a positive PCR by nasopharyngeal swab or positive antibody test, 2) donor has been symptom free for 10 days and 3) must pass all other blood donor criteria established by the FDA. Blood donors who want to proceed with regular blood donation are eligible after 28 days of being symptom free, regardless of testing status.

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Reference: COVID-19 convalescent plasma

A 27 year old man, who recently received a hematopoietic stem cell transplant (HSCT) for B cell acute lymphoblastic lymphoma (B ALL), blood type A negative, positive for COVID-19 by viral PCR, has been in the ICU for 3 days with bilevel positive airway pressure (BIPAP) for severe respiratory distress. His family recently heard about convalescent plasma for COVID-19 (CCP) on the news and wants him to receive this therapy. The blood bank has 1 high titer (1:1,350) CCP unit available that is blood type O positive. The clinical team wants your thoughts on how to respond to the family.

1. The patient can receive the unit because it is type compatible and he qualifies based on the severity of the disease and his preexisting conditions
2. The patient can receive the unit but only if the anti-A titers are ≤ 1:128 due to type incompatibility; he qualifies based on the severity of the disease and his preexisting conditions
3. The patient should not receive the unit, because of the risk of anti-A in a plasma unit
4. The patient should not receive the unit, because he is past 72 hours of disease, so the CCP would not be effective
5. The patient should not receive the unit, because his age and preexisting conditions do not put him in a high risk category

B. The patient can receive the unit but only if the anti-A titers are ≤ 1:128 due to type incompatibility; he qualifies based on the severity of the disease and his preexisting conditions. This patient is very ill with COVID-19, with significant risk factors (B ALL, status post-HSCT). He would likely still benefit from convalescent plasma (based on current available data). The problem is that the only available unit is not compatible with his blood type. Recall that a blood type O unit will have anti-A and anti-B in the plasma (see table). This unit is associated with a risk of causing hemolytic transfusion reaction. Although it has not been studied, it is at the discretion of the provider to allow incompatible units for the patient. In this scenario, an anti-A titer of ≤ 1:128 is recommended but may vary by institution.

Blood type	Antigen on red cell	Antibody in plasma
O	None	Anti-A and anti-B
A	A	Anti-B
B	B	Anti-A
AB	A and B	None

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Reference: COVID-19 convalescent plasma