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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Participants will receive one infusion of convalescent plasma proportional to their weight (10 mL/kg), up to a maximum of 500 mL
Alberta Children's Hospital
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
Clinical recovery
defined in the last 24 hours as normal respiratory and heart rate (or return to baseline, absence of fever, absence of low blood pressure, oxygen saturation greater than 94% or room air (or return to baseline), no need for intravenous fluids (or return to baseline)
Time frame: at day 30
Combined mortality/intubation
Proportion of patients experiencing death in hospital (Yes/No) 30 days
Time frame: at 30 day
Respiratory status-1
Proportion of patients experiencing Intubation (Yes/No)
Time frame: at 30 days
Respiratory status-2
time to intubation
Time frame: time from admission to intubation
Respiratory status-3
Mean number of ventilator-free days in 30 days
Time frame: from admission to day 30 of hospitalization
respiratory status -4
Mean number of ventilator days in 30 days
Time frame: from admission to day 30 of hospitalization
respiratory status -5
The number of oxygen free days in the first 30 days or the incidence and duration of new oxygen use during the trial, defined as oxygen use that was not present at time of randomization but occurs subsequently
Time frame: from admission to day 30 of hospitalization
respiratory status-6
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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
...and 3 more locations
The proportion of patients needing ECMO in 30 days
Time frame: at 30 days
Mortality 1a
Time to in-hospital death censored
Time frame: at 30 days
Mortality 1b
Time to in-hospital death censored
Time frame: at 90 days
Mortality 2a
Proportion of patients with Survival status
Time frame: at 30 days
Mortality 2b
Proportion of patients with Survival status
Time frame: at 90 days
Care and Critical Care
Length of hospitalization and stay in the ICU
Time frame: at 30 days
organ systems: renal
The proportion of patients needing renal replacement therapy
Time frame: up to 365 days
organ systems: cardiac
The proportion of patients developing myocarditis
Time frame: up to 365 days
Transfusion-associated adverse events (AE)
The proportion of patients developing adverse events to the treatment arm, C19-CP as assessed by Proposed Standard definitions for surveillance of non-infectious adverse transfusion reactions.
Time frame: up to 365 days
Safety of the intervention
cumulative incidence of severe and life-threatening AEs and severe AEs
Time frame: up to 365 days
organ systems: multi-system inflammatory disease
The proportion of patients developing multi-system inflammatory disease
Time frame: up to 365 days