Convalescent Plasma Collection and Treatment in Pediatrics and Adults

Inclusion Criteria: (NOTE: It is important to note that West Virginia, as a state, does not have any entity with the required FDA registration or licensure, nor the necessary on-site equipment, to collect convalescent plasma for the purpose of plasma transfusion. Therefore, the plasma donation portion of this study was not completed).

• Plasma donation:
• Prior diagnosis of COVID-19 documented by a laboratory test
• Abbott RealTime SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) test on the Abbott m2000 System (Inpatient WVU testing)
• Other testing methods and vendors using FDA approved detection methods of SARS-CoV-2 under the Emergency Use Authorization (EUA)
• Complete resolution of symptoms at least 28 days prior to donation
• Complete resolution of symptoms for at least 14 days with negative repeat COVID-19 testing approved by the FDA EUA
• Female donors age 18+ that have never been pregnant or negative for HLA antibodies
• Male donors age 18+
• Negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by a molecular diagnostic test from blood. A partial list of available tests can be accessed at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.
• Defined SARS-CoV-2 neutralizing antibody titers, if testing can be conducted (e.g., of at least 1:1602, 1:360 up to 1:640 is preferred. In shortage case 1:80 is acceptable)
• At least or greater than 50kg of weight
• Plasma Recipients:
• Individuals of any age above 30 days of life, sex, or pregnancy status suffering from confirmed COVID19 and in rapid progression, severe or critical condition meeting the FDA IND guidelines.
• Must have laboratory confirmed COVID19
• Must have severe or immediately life-threatening COVID19
• Must provide informed consent/assent

Exclusion Criteria

• Plasma donation:
• Individuals that do not meet the requirement from the American Red Cross for plasma donation or equivalent
• Individuals plasma that has not passed safety screening after procurement by the American Red Cross for plasma donation or equivalent
• Plasma Recipients
• Individuals with COVID19 who are not in clinical concern for rapid progression, severe or critical condition
• Individuals who are in critical condition that are not confirmed to have COVID19
• Individuals with known Selective IgA Deficiency, that has not been found to be absent of anti-IgA antibodies