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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04377568
Other study ID # 1000070143
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date October 7, 2020
Est. completion date May 1, 2022

Study information

Verified date April 2021
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 in hospitalized children in the context of the COVID-19 pandemic.


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 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 1, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Canada Alberta Children's Hospital Calgary Alberta
Canada Stollery Children's Hospital Edmonton Alberta
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 CHU Sainte-Justine Montréal Quebec
Canada McGill Univ Health Ctr - Montreal Children's Hospital Montréal Quebec
Canada Children's Hospital of Eastern Ontario Ottawa Ontario
Canada Jim Pattison Children's Hospital Saskatoon Saskatchewan
Canada The Hospital for Sick Children Toronto Ontario
Canada BC Children's Hospital Vancouver British Columbia
Canada Winnipeg Children's Hospital Winnipeg Manitoba

Sponsors (2)

Lead Sponsor Collaborator
The Hospital for Sick Children C17 Council (regulatory sponsor)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Virological measures 1 Proportion of patients with negative virology at day 3
Other Virological measures 3 Proportion of patients with negative virology at day 10
Other Virological measures 4 Proportion of patients with negative virology at day 15
Other Modulation of biomarkers Exploratory analysis of biomarker differences between groups up to 365 days
Other Resolution of fever Time to fever resolution (no longer requiring fever management) hours
Other 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. at day 30
Other Functional measure 1 efficacy of C19-CP on respiratory measures using pediatric validated dyspnea (breathlessness) scales up to 365 days
Other Functional measure 2 Evaluate the efficacy of C19-CP on quality of life (QOL) measures using Validated QOL scores (Eq-5D) up to 365 days
Other Functional measure 3 Evaluate the efficacy of C19-CP on rehospitalization after discharge up to 365 days
Primary 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) at day 30
Secondary Combined mortality/intubation Proportion of patients experiencing death in hospital (Yes/No) 30 days at 30 day
Secondary Respiratory status-1 Proportion of patients experiencing Intubation (Yes/No) at 30 days
Secondary Respiratory status-2 time to intubation time from admission to intubation
Secondary Respiratory status-3 Mean number of ventilator-free days in 30 days from admission to day 30 of hospitalization
Secondary respiratory status -4 Mean number of ventilator days in 30 days from admission to day 30 of hospitalization
Secondary 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 from admission to day 30 of hospitalization
Secondary respiratory status-6 The proportion of patients needing ECMO in 30 days at 30 days
Secondary Mortality 1a Time to in-hospital death censored at 30 days
Secondary Mortality 1b Time to in-hospital death censored at 90 days
Secondary Mortality 2a Proportion of patients with Survival status at 30 days
Secondary Mortality 2b Proportion of patients with Survival status at 90 days
Secondary Care and Critical Care Length of hospitalization and stay in the ICU at 30 days
Secondary organ systems: renal The proportion of patients needing renal replacement therapy up to 365 days
Secondary organ systems: cardiac The proportion of patients developing myocarditis up to 365 days
Secondary 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. up to 365 days
Secondary Safety of the intervention cumulative incidence of severe and life-threatening AEs and severe AEs up to 365 days
Secondary organ systems: multi-system inflammatory disease The proportion of patients developing multi-system inflammatory disease up to 365 days
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