Convalescent Plasma Collection and Treatment in Pediatrics and Adults

Launched by WEST VIRGINIA UNIVERSITY · May 1, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the use of convalescent plasma to treat patients with COVID-19. Convalescent plasma is blood plasma collected from people who have recovered from COVID-19, containing antibodies that may help fight the virus in those currently infected. The trial aims to include up to 240 participants who are suffering from COVID-19 and may receive different amounts of plasma based on the severity of their illness—mild, moderate, or severe. In total, the study will also reach out to potentially 1,000 donors who have recovered from COVID-19.

To be eligible for this trial as a plasma donor, individuals must have a confirmed previous COVID-19 diagnosis, be symptom-free for at least 28 days, and meet other health criteria. For those receiving plasma, participants must be at least 30 days old, have a confirmed case of COVID-19, and be experiencing severe or rapidly worsening symptoms. There is no placebo group in this trial, meaning all participants receiving treatment will get actual convalescent plasma. If you or a loved one is interested, this trial is currently recruiting participants and could be an important option for those with severe COVID-19 symptoms.

Gender

ALL

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 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