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Efficacy of Human Coronavirus-immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children (CONCOR-KIDS)

Primary Purpose

Hospitalized Children, Covid-19 Infection

Status
Withdrawn
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Convalescent plasma (CP)
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hospitalized Children focused on measuring covid-19, hospitalized children, convalescent plasma therapy

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alberta Children's Hospital
  • Stollery Children's Hospital
  • BC Children's Hospital
  • Winnipeg Children's Hospital
  • IWK Health Centre
  • McMaster Children's Hospital
  • Kingston Health Sciences Centre
  • Children's Hospital
  • Children's Hospital of Eastern Ontario
  • The Hospital for Sick Children
  • CHU Sainte-Justine
  • McGill Univ Health Ctr - Montreal Children's Hospital
  • Jim Pattison Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Convalescent Plasma + Standard of Care (C19-CP + SoC)

Standard of Care (SoC)

Arm Description

Participants will receive COVID-19 convalescent plasma (C19-CP) plus standard of care while being hospitalized for COVID-19.

Participants will receive standard of care while being hospitalized for COVID-19.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Combined mortality/intubation
Proportion of patients experiencing death in hospital (Yes/No) 30 days
Respiratory status-1
Proportion of patients experiencing Intubation (Yes/No)
Respiratory status-2
time to intubation
Respiratory status-3
Mean number of ventilator-free days in 30 days
respiratory status -4
Mean number of ventilator days in 30 days
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
respiratory status-6
The proportion of patients needing ECMO in 30 days
Mortality 1a
Time to in-hospital death censored
Mortality 1b
Time to in-hospital death censored
Mortality 2a
Proportion of patients with Survival status
Mortality 2b
Proportion of patients with Survival status
Care and Critical Care
Length of hospitalization and stay in the ICU
organ systems: renal
The proportion of patients needing renal replacement therapy
organ systems: cardiac
The proportion of patients developing myocarditis
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.
Safety of the intervention
cumulative incidence of severe and life-threatening AEs and severe AEs
organ systems: multi-system inflammatory disease
The proportion of patients developing multi-system inflammatory disease

Full Information

First Posted
April 30, 2020
Last Updated
April 21, 2021
Sponsor
The Hospital for Sick Children
Collaborators
C17 Council (regulatory sponsor)
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1. Study Identification

Unique Protocol Identification Number
NCT04377568
Brief Title
Efficacy of Human Coronavirus-immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children
Acronym
CONCOR-KIDS
Official Title
A Randomized, Multicentered, Open-label Phase 2 Clinical Trial of the Safety and Efficacy of Human Coronavirus- Immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
no enrollment
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
C17 Council (regulatory sponsor)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospitalized Children, Covid-19 Infection
Keywords
covid-19, hospitalized children, convalescent plasma therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized to receive either standard of care (SoC) products (control) or COVID-19 convalescent plasma (C19-CP) plus standard of care while being hospitalized for COVID-19 (ratio 1:2). The intervention will consist of a single transfusion of convalescent plasma.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Convalescent Plasma + Standard of Care (C19-CP + SoC)
Arm Type
Experimental
Arm Description
Participants will receive COVID-19 convalescent plasma (C19-CP) plus standard of care while being hospitalized for COVID-19.
Arm Title
Standard of Care (SoC)
Arm Type
No Intervention
Arm Description
Participants will receive standard of care while being hospitalized for COVID-19.
Intervention Type
Biological
Intervention Name(s)
Convalescent plasma (CP)
Intervention Description
Participants will receive one infusion of convalescent plasma proportional to their weight (10 mL/kg), up to a maximum of 500 mL
Primary Outcome Measure Information:
Title
Clinical recovery
Description
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
Secondary Outcome Measure Information:
Title
Combined mortality/intubation
Description
Proportion of patients experiencing death in hospital (Yes/No) 30 days
Time Frame
at 30 day
Title
Respiratory status-1
Description
Proportion of patients experiencing Intubation (Yes/No)
Time Frame
at 30 days
Title
Respiratory status-2
Description
time to intubation
Time Frame
time from admission to intubation
Title
Respiratory status-3
Description
Mean number of ventilator-free days in 30 days
Time Frame
from admission to day 30 of hospitalization
Title
respiratory status -4
Description
Mean number of ventilator days in 30 days
Time Frame
from admission to day 30 of hospitalization
Title
respiratory status -5
Description
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
Title
respiratory status-6
Description
The proportion of patients needing ECMO in 30 days
Time Frame
at 30 days
Title
Mortality 1a
Description
Time to in-hospital death censored
Time Frame
at 30 days
Title
Mortality 1b
Description
Time to in-hospital death censored
Time Frame
at 90 days
Title
Mortality 2a
Description
Proportion of patients with Survival status
Time Frame
at 30 days
Title
Mortality 2b
Description
Proportion of patients with Survival status
Time Frame
at 90 days
Title
Care and Critical Care
Description
Length of hospitalization and stay in the ICU
Time Frame
at 30 days
Title
organ systems: renal
Description
The proportion of patients needing renal replacement therapy
Time Frame
up to 365 days
Title
organ systems: cardiac
Description
The proportion of patients developing myocarditis
Time Frame
up to 365 days
Title
Transfusion-associated adverse events (AE)
Description
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
Title
Safety of the intervention
Description
cumulative incidence of severe and life-threatening AEs and severe AEs
Time Frame
up to 365 days
Title
organ systems: multi-system inflammatory disease
Description
The proportion of patients developing multi-system inflammatory disease
Time Frame
up to 365 days
Other Pre-specified Outcome Measures:
Title
Virological measures 1
Description
Proportion of patients with negative virology
Time Frame
at day 3
Title
Virological measures 3
Description
Proportion of patients with negative virology
Time Frame
at day 10
Title
Virological measures 4
Description
Proportion of patients with negative virology
Time Frame
at day 15
Title
Modulation of biomarkers
Description
Exploratory analysis of biomarker differences between groups
Time Frame
up to 365 days
Title
Resolution of fever
Description
Time to fever resolution (no longer requiring fever management)
Time Frame
hours
Title
Presence and titres levels
Description
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
Title
Functional measure 1
Description
efficacy of C19-CP on respiratory measures using pediatric validated dyspnea (breathlessness) scales
Time Frame
up to 365 days
Title
Functional measure 2
Description
Evaluate the efficacy of C19-CP on quality of life (QOL) measures using Validated QOL scores (Eq-5D)
Time Frame
up to 365 days
Title
Functional measure 3
Description
Evaluate the efficacy of C19-CP on rehospitalization after discharge
Time Frame
up to 365 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Upton, MD, MPH
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kathy Brodeur-Robb
Organizational Affiliation
C17 Council (regulatory sponsor)
Official's Role
Study Director
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
BC Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
Winnipeg Children's Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 1X7
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Kingston Health Sciences Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Children's Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 2V5
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada
Facility Name
CHU Sainte-Justine
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
McGill Univ Health Ctr - Montreal Children's Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Jim Pattison Children's Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Human Coronavirus-immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children

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