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

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ClinicalTrials.gov Identifier: NCT04377568
Recruitment Status : Not yet recruiting
First Posted : May 6, 2020
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
C17 Council (regulatory sponsor)
Information provided by (Responsible Party):
Julia Upton, The Hospital for Sick Children

Tracking Information
First Submitted Date  ICMJE April 30, 2020
First Posted Date  ICMJE May 6, 2020
Last Update Posted Date June 25, 2020
Estimated Study Start Date  ICMJE July 15, 2020
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
Clinical recovery [ Time Frame: at day 30 ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2020)
  • Combined mortality/intubation [ Time Frame: at 30 day ]
    Proportion of patients experiencing death in hospital (Yes/No) 30 days
  • Respiratory status-1 [ Time Frame: at 30 days ]
    Proportion of patients experiencing Intubation (Yes/No)
  • Respiratory status-2 [ Time Frame: time from admission to intubation ]
    time to intubation
  • Respiratory status-3 [ Time Frame: from admission to day 30 of hospitalization ]
    Mean number of ventilator-free days in 30 days
  • respiratory status -4 [ Time Frame: from admission to day 30 of hospitalization ]
    Mean number of ventilator days in 30 days
  • respiratory status -5 [ Time Frame: from admission to day 30 of hospitalization ]
    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 [ Time Frame: at 30 days ]
    The proportion of patients needing ECMO in 30 days
  • Mortality 1a [ Time Frame: at 30 days ]
    Time to in-hospital death censored
  • Mortality 1b [ Time Frame: at 90 days ]
    Time to in-hospital death censored
  • Mortality 2a [ Time Frame: at 30 days ]
    Proportion of patients with Survival status
  • Mortality 2b [ Time Frame: at 90 days ]
    Proportion of patients with Survival status
  • Care and Critical Care [ Time Frame: at 30 days ]
    Length of hospitalization and stay in the ICU
  • organ systems: renal [ Time Frame: up to 365 days ]
    The proportion of patients needing renal replacement therapy
  • organ systems: cardiac [ Time Frame: up to 365 days ]
    The proportion of patients developing myocarditis
  • Transfusion-associated adverse events (AE) [ Time Frame: up to 365 days ]
    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 [ Time Frame: up to 365 days ]
    cumulative incidence of severe and life-threatening AEs and severe AEs
  • organ systems: multi-system inflammatory disease [ Time Frame: up to 365 days ]
    The proportion of patients developing multi-system inflammatory disease
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • Combined mortality/intubation [ Time Frame: at 30 day ]
    Proportion of patients experiencing death in hospital (Yes/No) 30 days
  • Respiratory status-1 [ Time Frame: at 30 days ]
    Proportion of patients experiencing Intubation (Yes/No)
  • Respiratory status-2 [ Time Frame: time from admission to intubation ]
    time to intubation
  • Respiratory status-3 [ Time Frame: from admission to day 30 of hospitalization ]
    Mean number of ventilator-free days in 30 days
  • respiratory status -4 [ Time Frame: from admission to day 30 of hospitalization ]
    Mean number of ventilator days in 30 days
  • respiratory status -5 [ Time Frame: from admission to day 30 of hospitalization ]
    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 [ Time Frame: at 30 days ]
    The proportion of patients needing ECMO in 30 days
  • Mortality 1a [ Time Frame: at 30 days ]
    Time to in-hospital death censored
  • Mortality 1b [ Time Frame: at 90 days ]
    Time to in-hospital death censored
  • Mortality 2a [ Time Frame: at 30 days ]
    Proportion of patients with Survival status
  • Mortality 2b [ Time Frame: at 90 days ]
    Proportion of patients with Survival status
  • Care and Critical Care [ Time Frame: at 30 days ]
    Length of hospitalization and stay in the ICU
  • organ systems: renal [ Time Frame: up to 365 days ]
    The proportion of patients needing renal replacement therapy
  • organ systems: cardiac [ Time Frame: up to 365 days ]
    The proportion of patients developing myocarditis
  • Transfusion-associated adverse events (AE) [ Time Frame: up to 365 days ]
    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 [ Time Frame: up to 365 days ]
    cumulative incidence of severe and life-threatening AEs and severe AEs
Current Other Pre-specified Outcome Measures
 (submitted: June 22, 2020)
  • Virological measures 1 [ Time Frame: at day 3 ]
    Proportion of patients with negative virology
  • Virological measures 2 [ Time Frame: at day 5 ]
    Proportion of patients with negative virology
  • Virological measures 3 [ Time Frame: at day 10 ]
    Proportion of patients with negative virology
  • Virological measures 4 [ Time Frame: at day 15 ]
    Proportion of patients with negative virology
  • Modulation of biomarkers [ Time Frame: up to 365 days ]
    Exploratory analysis of biomarker differences between groups
  • Resolution of fever [ Time Frame: hours ]
    Time to fever resolution (no longer requiring fever management)
  • Presence and titres levels [ Time Frame: at day 30 ]
    Presence and titres of IgG, IgA antibodies and neutralizing antibody titres in C19-CP group on the primary outcome and other outcomes.
  • Functional measure 1 [ Time Frame: up to 365 days ]
    efficacy of C19-CP on respiratory measures using pediatric validated dyspnea (breathlessness) scales
  • Functional measure 2 [ Time Frame: up to 365 days ]
    Evaluate the efficacy of C19-CP on quality of life (QOL) measures using Validated QOL scores (Eq-5D)
  • Functional measure 3 [ Time Frame: up to 365 days ]
    Evaluate the efficacy of C19-CP on rehospitalization after discharge
Original Other Pre-specified Outcome Measures
 (submitted: May 4, 2020)
  • Virological measures 1 [ Time Frame: at day 3 ]
    Proportion of patients with negative virology
  • Virological measures 2 [ Time Frame: at day 5 ]
    Proportion of patients with negative virology
  • Virological measures 3 [ Time Frame: at day 10 ]
    Proportion of patients with negative virology
  • Virological measures 4 [ Time Frame: at day 15 ]
    Proportion of patients with negative virology
  • Modulation of biomarkers [ Time Frame: up to 365 days ]
    Exploratory analysis of biomarker differences between groups
  • Resolution of fever [ Time Frame: hours ]
    Time to fever resolution (no longer requiring fever management)
  • Presence and titres levels [ Time Frame: at 30 days ]
    Presence and titres of IgG, IgA antibodies and neutralizing antibody titres in C19-CP groupon rates of intubation for mechanical ventilation or death in hospital
  • Functional measure 1 [ Time Frame: up to 365 days ]
    efficacy of C19-CP on respiratory measures using pediatric validated dyspnea (breathlessness) scales
  • Functional measure 2 [ Time Frame: up to 365 days ]
    Evaluate the efficacy of C19-CP on quality of life (QOL) measures using Validated QOL scores (Eq-5D)
  • Functional measure 3 [ Time Frame: up to 365 days ]
    Evaluate the efficacy of C19-CP on rehospitalization after discharge
 
Descriptive Information
Brief Title  ICMJE Efficacy of Human Coronavirus-immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE
  • Hospitalized Children
  • Covid-19 Infection
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Convalescent Plasma + Standard of Care (C19-CP + SoC)
    Participants will receive COVID-19 convalescent plasma (C19-CP) plus standard of care while being hospitalized for COVID-19.
    Intervention: Biological: Convalescent plasma (CP)
  • No Intervention: Standard of Care (SoC)
    Participants will receive standard of care while being hospitalized for COVID-19.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2022
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Julia Upton 416 813 7654 ext 208634 julia.upton@sickkids.ca
Contact: Christoph Licht christoph.licht@sickkids.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04377568
Other Study ID Numbers  ICMJE 1000070143
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julia Upton, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE C17 Council (regulatory sponsor)
Investigators  ICMJE
Study Chair: Julia Upton, MD, MPH The Hospital for Sick Children
Study Director: Kathy Brodeur-Robb C17 Council (regulatory sponsor)
PRS Account The Hospital for Sick Children
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP