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 in hospitalized children in the context of the COVID-19 pandemic.
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 the number of COVID-19 cases will continue to rise over the coming weeks and
months. There is an urgent public health need for rapid development of novel interventions.
This protocol aims to use passive antibody therapy via convalescent plasma from
SARS-CoV-2-infected patients who have developed antibody immunity, COVID-19 convalescent
plasma (C19-CP), as treatment for hospitalized children with COVID-19 disease at pediatric
academic hospitals across Canada. The unknown role for convalescent plasma in treating
COVID-19 necessitates further study.
Biological: Convalescent plasma (CP)
Participants will receive one infusion of convalescent plasma proportional to their weight (10 mL/kg), up to a maximum of 500 mL
Inclusion Criteria:
1. Age 0 to <19 years old
2. Hospitalized with symptoms compatible with COVID-19 illness
3. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or
public health assay in any specimen prior to randomization.
4. ABO compatible convalescent plasma available
Exclusion Criteria:
1. Onset of symptoms began >12 days before screening
2. History of adverse reactions to blood products or other contraindication to
transfusion
3. Refusal of plasma for religious or other reasons
4. Acute heart failure with fluid overload
5. 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
6. 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.
Alberta Children's Hospital
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
Winnipeg Children's Hospital
Winnipeg, Manitoba, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
Children's Hospital
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
CHU Sainte-Justine
Montréal, Quebec, Canada
McGill Univ Health Ctr - Montreal Children's Hospital
Montréal, Quebec, Canada
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, Canada