Status:
WITHDRAWN
Efficacy of Human Coronavirus-immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
C17 Council (regulatory sponsor)
Conditions:
Hospitalized Children
Covid-19 Infection
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief Summary
This is a multicentered, open-label, randomized controlled Phase 2 trial to evaluate the safety and efficacy of providing human coronavirus-immune convalescent plasma as treatment for COVID-19 disease...
Detailed Description
SARS-CoV-2 viral infection resulting in COVID-19 disease has recently been designated by the World Health Organization as a global pandemic. Outbreak forecasting and mathematical models suggest that t...
Eligibility Criteria
Inclusion
- Age 0 to \<19 years old
- Hospitalized with symptoms compatible with COVID-19 illness
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen prior to randomization.
- ABO compatible convalescent plasma available
Exclusion
- Onset of symptoms began \>12 days before screening
- History of adverse reactions to blood products or other contraindication to transfusion
- Refusal of plasma for religious or other reasons
- Acute heart failure with fluid overload
- Any condition or diagnosis, that could in the opinion of the Site Principal Investigator interfere with the participant's ability to comply with study instructions, or put the participant at risk
- Anticipated discharge within 24 hours
- Note: The intent of this exclusion criteria is to only include participants with acute COVID-19 infections. This protocol is not intended to include participants with post-infectious complications. In cases where the distinction is not clear, participant eligibility will be discussed with the study steering committee prior to enrollment.
Key Trial Info
Start Date :
October 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04377568
Start Date
October 7 2020
End Date
May 1 2022
Last Update
April 23 2021
Active Locations (13)
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1
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
2
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
3
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
4
Winnipeg Children's Hospital
Winnipeg, Manitoba, Canada, R3C 1X7