A Phase 2 interventional study of Convalescent plasma (CP) in Hospitalized Children and Covid-19 Infection, sponsored by The Hospital for Sick Children. Withdrawn at 13 sites in Canada. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2021-04-23.
Sponsored by The Hospital for Sick Children · Phase 2, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
Browse COVID-19 studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Participants will receive COVID-19 convalescent plasma (C19-CP) plus standard of care while being hospitalized for COVID-19.
Biological: Convalescent plasma (CP)
Participants will receive standard of care while being hospitalized for COVID-19.
Participants will receive one infusion of convalescent plasma proportional to their weight (10 mL/kg), up to a maximum of 500 mL
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
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
Virological measures 1
Proportion of patients with negative virology
Time frame: at day 3
Virological measures 3
Proportion of patients with negative virology
Time frame: at day 10
Virological measures 4
Proportion of patients with negative virology
Time frame: at day 15
Modulation of biomarkers
Exploratory analysis of biomarker differences between groups
Time frame: up to 365 days
Resolution of fever
Time to fever resolution (no longer requiring fever management)
Time frame: hours
Presence and titres levels
Presence and titres of IgG, IgA antibodies and neutralizing antibody titres in C19-CP group on the primary outcome and other outcomes.
Time frame: at day 30
Functional measure 1
efficacy of C19-CP on respiratory measures using pediatric validated dyspnea (breathlessness) scales
Time frame: up to 365 days
Functional measure 2
Evaluate the efficacy of C19-CP on quality of life (QOL) measures using Validated QOL scores (Eq-5D)
Time frame: up to 365 days
Functional measure 3
Evaluate the efficacy of C19-CP on rehospitalization after discharge
Time frame: up to 365 days
This study is withdrawn, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children