Status:
RECRUITING
Convalescent Plasma Collection and Treatment in Pediatrics and Adults
Lead Sponsor:
West Virginia University
Conditions:
COVID19
Coronavirus Infection
Eligibility:
All Genders
31+ years
Phase:
PHASE3
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 guideline...
Detailed Description
Convalescent plasma (here on referred to as plasma) has been used in emergency life-threatening situations to treat infections for over 100 years. The plasma is donated by an individual that has recov...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2021
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04376034
Start Date
April 16 2020
End Date
March 30 2021
Last Update
May 6 2020
Active Locations (1)
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1
WVU Medicine
Morgantown, West Virginia, United States, 26506