Convalescent Plasma Collection and Treatment in Pediatrics and Adults (NCT04376034) | Clinical Trial Compass
CompletedPhase 3
Convalescent Plasma Collection and Treatment in Pediatrics and Adults
United States117 participantsStarted 2020-04-16
Plain-language summary
This is a prospective study, using plasma to help fight off infections of those suffering from COVID-19 in accordance with collection guidelines for plasma and FDA IND requirements. This study included up to 240 participants potentially receiving convalescent plasma.
NOTE: West Virginia does not have any entity with the required FDA registration/licensure or necessary equipment to collect convalescent plasma for transfusion. Therefore, the plasma donation portion of this study was not completed.
Who can participate
Age range
31 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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
. 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