SARSCoV2 (COVID-19) Convalescent Plasma (CP) Expanded Access Protocol (EAP)

Inclusion Criteria:

• Ages 6 and up
• Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants ≥ 18 years of age); or willing and able to provide assent as required per Institutional Review Board (IRB) prior to performing study procedures.
• Must have laboratory confirmed COVID-19 positive test
• Must have severe or immediately life-threatening COVID-19

Severe disease is defined as:

1. dyspnea
2. respiratory frequency ≥ 30/min
3. blood oxygen saturation ≤ 93%
4. partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or

5. lung infiltrates > 50% within 24 to 48 hours

   Life-threatening disease is defined as:

6. respiratory failure
7. septic shock, and/or
8. multiple organ dysfunction or failure

Exclusion Criteria:

• Known contraindication to transfusion or history of prior reactions to transfusion of blood products