Status:
COMPLETED
Convalescent Plasma in Pediatric COVID-19
Lead Sponsor:
Emory University
Conditions:
COVID
Eligibility:
All Genders
Up to 22 years
Phase:
EARLY_PHASE1
Brief Summary
COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been adequately studied in children to date. The study will determine safety of convalescent plasma for pediatric patie...
Detailed Description
COVID19 is an emerging infection with no current approved treatment or prevention. COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been adequately studied in children ...
Eligibility Criteria
Inclusion
- Aged 0 to 22 years of age
- SARS-CoV-2 infection documented by RNA RT-PCR detection
- Admitted to an acute care facility
- Ability of patient or guardian to provide consent and assent (if applicable); if patient is intubated assent may be waived
Exclusion
- Pregnancy/ breast feeding
- Medical condition that increases the risk of plasma infusion
- Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
- Inclusion criteria for infusion:
- Severe COVID-19 disease, OR
- Moderate disease with a risk of progression to severe or life threatening disease, OR
- Severely immunocompromised patient with any illness attributed to COVID-19 disease requiring inpatient care.
- Exclusion to infusion:
- Pregnancy/ breast feeding
- Medical condition that increases the risk of plasma infusion
- Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
Key Trial Info
Start Date :
July 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04458363
Start Date
July 4 2020
End Date
September 1 2020
Last Update
November 22 2021
Active Locations (1)
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1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322