Convalescent Plasma Collection and Treatment in Pediatrics and Adults
1 other identifier
interventional
240
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 covid19
Started Apr 2020
Typical duration for phase_3 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2020
CompletedFirst Submitted
Initial submission to the registry
April 19, 2020
CompletedFirst Posted
Study publicly available on registry
May 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2021
CompletedMay 6, 2020
May 1, 2020
12 months
April 19, 2020
May 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Plasma Donor
Time it takes to identify eligible donors whom are willing to donate
Measured in days for 365 days
Plasma Donor
Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma
Measured in days for 365 days
Plasma Recipient
Time from consent to infusion
Measured evey 24 hours up to 30 days
Plasma Recipient
Survival
Measured in days with 30 day from discharge follow-up
Secondary Outcomes (5)
Plasma Donor
Measured every 24 hours up to 1 year
Plasma Recipient
Day 1, 2, 3, 4, 7, and 30 day
Plasma Recipient
Day 1, 2, 3, 4, 7, and 30 day
Plasma Recipient
Measured every 24 hours until patient discharged from hospital up to 1 year
Plasma Recipient
Measured every 24 hours until Off Advanced Respiratory Support up to 1 year
Study Arms (3)
Mild Severity
OTHEREligible to enroll in study and will be monitored for progression. Will not initially receive plasma.
Moderate Severity
ACTIVE COMPARATORAdult patients will be treated with 1 unit (200mL) of convalescent plasma Pediatric patients will be treated with 10mg/kg up to 1 unit of convalescent plasma.
Severe or Critical Severity
ACTIVE COMPARATORAdult patients will be treated with up to 2 units of convalescent plasma Pediatric patients will be treated with 10mg/kg up to 2 units of convalescent plasma.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
WVU Medicine
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Peppers, DO, PhD
WVU Medicine Children's
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2020
First Posted
May 6, 2020
Study Start
April 16, 2020
Primary Completion
March 30, 2021
Study Completion
March 30, 2021
Last Updated
May 6, 2020
Record last verified: 2020-05