Actively Recruiting
Convalescent Plasma Collection and Treatment in Pediatrics and Adults
Led by West Virginia University · Updated on 2020-05-06
240
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Convalescent Plasma Collection and Treatment in Pediatrics and Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prior laboratory-confirmed diagnosis of COVID-19 for plasma donation
- Complete resolution of COVID-19 symptoms at least 28 days before donation
- Alternatively, complete symptom resolution for at least 14 days with negative repeat COVID-19 test approved by FDA
- Female donors age 18 or older who have never been pregnant or test negative for HLA antibodies
- Male donors age 18 or older
- Negative COVID-19 test results from nasopharyngeal swab or molecular blood test
- Defined SARS-CoV-2 neutralizing antibody titers if available (preferred 1:1602 to 1:640, minimum 1:80)
- Weight at least 50 kg for plasma donors
- Plasma recipients of any age above 30 days, any sex or pregnancy status, with confirmed COVID-19 and rapid progression, severe or critical condition per FDA IND guidelines
- Laboratory confirmed COVID-19 infection for recipients
- Severe or immediately life-threatening COVID-19 for recipients
- Informed consent or assent provided by recipients
You will not qualify if you...
- Do not meet American Red Cross or equivalent plasma donation requirements
- Plasma that fails safety screening after collection
- COVID-19 patients not at risk for rapid progression, severe, or critical illness
- Critically ill individuals not confirmed to have COVID-19
- Known Selective IgA Deficiency with presence of anti-IgA antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
WVU Medicine
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
B
Brian Peppers, DO, PhD
CONTACT
L
Lisa Giblin Sutton, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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