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RECRUITING

NCT04376034

PHASE3

Convalescent Plasma Collection and Treatment in Pediatrics and Adults

Sponsor: West Virginia University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

31 Days - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2020-04-16

Completion Date

2021-03-30

Last Updated

2020-05-06

Healthy Volunteers

Conditions

COVID19 Coronavirus Infection Coronavirus Virus Diseases RNA Virus Infections

Interventions

BIOLOGICAL

Convalescent 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.

BIOLOGICAL

Convalescent 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.

OTHER

Standard 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.

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

Locations (1)

WVU Medicine

Morgantown, West Virginia, United States