RECRUITING

Convalescent Plasma Collection and Treatment in Pediatrics and Adults

Conditions

COVID19 Coronavirus Infection Coronavirus Virus Diseases RNA Virus Infections Covid 19 Convalescent Plasma SARS-CoV-2 Pediatric Pediatrics

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2020-04-16

Study Completion:2021-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04376034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:31 Days

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Brian Peppers, DO, PhD

CONTACT

304-594-2483

brian.peppers@hsc.wvu.edu

Lisa Giblin Sutton, PharmD

CONTACT

304-293-0928

giblinl@wvumedicine.org

Principal Investigator

Brian Peppers, DO, PhD

PRINCIPAL_INVESTIGATOR

WVU Medicine Children's

Study Locations (Sites)

WVU Medicine

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: West Virginia University

Brian Peppers, DO, PhD, PRINCIPAL_INVESTIGATOR, WVU Medicine Children's

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-04-16

Study Completion Date2021-03-30

Study Record Updates

Study Start Date2020-04-16

Study Completion Date2021-03-30

Terms related to this study

Keywords Provided by Researchers

Covid19
Covid 19
Convalescent Plasma
SARS-CoV-2
Pediatric
Pediatrics

Additional Relevant MeSH Terms

COVID19
Coronavirus Infection
Coronavirus
Virus Diseases
RNA Virus Infections