Description
Inclusion Criteria:
- * Plasma donation:
- 1. Prior diagnosis of COVID-19 documented by a laboratory test
- 1. Abbott RealTime SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) test on the Abbott m2000 System (Inpatient WVU testing)
- 2. Other testing methods and vendors using FDA approved detection methods of SARS-CoV-2 under the Emergency Use Authorization (EUA)
- 2. Complete resolution of symptoms at least 28 days prior to donation
- 3. Complete resolution of symptoms for at least 14 days with negative repeat COVID-19 testing approved by the FDA EUA
- 4. Female donors age 18+ that have never been pregnant or negative for HLA antibodies
- 5. Male donors age 18+
- 6. 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.
- 7. 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)
- 8. At least or greater than 50kg of weight
- * Plasma Recipients:
- 1. 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.
- 2. Must have laboratory confirmed COVID19
- 3. Must have severe or immediately life-threatening COVID19
- 4. Must provide informed consent/assent
Exclusion Criteria:
- * Plasma donation:
- 1. Individuals that do not meet the requirement from the American Red Cross for plasma donation or equivalent
- 2. Individuals plasma that has not passed safety screening after procurement by the American Red Cross for plasma donation or equivalent
- * Plasma Recipients
- 1. Individuals with COVID19 who are not in clinical concern for rapid progression, severe or critical condition
- 2. Individuals who are in critical condition that are not confirmed to have COVID19
- 3. Individuals with known Selective IgA Deficiency, that has not been found to be absent of anti-IgA antibodies
Ages Eligible for Study:
31 Days to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No