Convalescent Plasma Collection and Treatment in Pediatrics and Adults
Trial Parameters
Brief Summary
This is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors. There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3 severity groups are eligible for enrollment, but mild severity will not be given plasma unless there is progression. Moderate severity will given up to 1 unit of plasma and severe/critical severity up to 2 units. There is no placebo group, however given the excepted issues of shortages of plasma, intention to treat will be used for analysis.
Eligibility Criteria
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 neut