RecruitingPhase 3NCT04376034

Convalescent Plasma Collection and Treatment in Pediatrics and Adults

Convalescent Plasma Collection From Individuals That Recovered From COVID19 and Treatment of Critically Ill Individuals With Donor Convalescent Plasma

Sponsor

West Virginia University

Enrollment

240 participants

Start Date

Apr 16, 2020

Study Type

INTERVENTIONAL

Conditions

COVID19 Coronavirus Coronavirus Infection Virus Diseases RNA Virus Infections

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

Min Age: 31 Days

Inclusion Criteria16

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 Criteria7

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

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Interventions

BIOLOGICALConvalescent Plasma 1 Unit

Each adult recipient will receive 1 units of plasma, each unit will consist of about 200 to 250 mL. Each pediatric recipient will receive 10mL/kg up to 1 unit of plasma.

BIOLOGICALConvalescent Plasma 2 Units

Those that meet severe or critical criteria will be given 2 units if available or 1 unit if 2 units are not available. Those that are given 1 unit may receive the second unit (or the remainder of the maximum pediatric weight calculated amount of plasma up to 1 additional unit) if they progress to severe or critical condition or if already in severe or critical condition but only received 1 unit secondary to shortages. Each pediatric recipient will receive 10mL/kg up to 2 units of plasma.

OTHERStandard of Care

Those that meet mild severity will be allowed to enroll in the study, but will not receive plasma unless there is progression of illness into the moderate/rapid progression or greater category.