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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Recruitment Status : Withdrawn (no enrollment)
First Posted : May 6, 2020
Last Update Posted : April 23, 2021
Sponsor:
Collaborator:
C17 Council (regulatory sponsor)
Information provided by (Responsible Party):
Julia Upton, The Hospital for Sick 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.

Condition or disease Intervention/treatment Phase
Hospitalized Children Covid-19 Infection Biological: Convalescent plasma (CP) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
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
Actual Study Start Date : October 7, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

No Intervention: Standard of Care (SoC)
Participants will receive standard of care while being hospitalized for COVID-19.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Combined mortality/intubation [ Time Frame: at 30 day ]
    Proportion of patients experiencing death in hospital (Yes/No) 30 days

  2. Respiratory status-1 [ Time Frame: at 30 days ]
    Proportion of patients experiencing Intubation (Yes/No)

  3. Respiratory status-2 [ Time Frame: time from admission to intubation ]
    time to intubation

  4. Respiratory status-3 [ Time Frame: from admission to day 30 of hospitalization ]
    Mean number of ventilator-free days in 30 days

  5. respiratory status -4 [ Time Frame: from admission to day 30 of hospitalization ]
    Mean number of ventilator days in 30 days

  6. 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

  7. respiratory status-6 [ Time Frame: at 30 days ]
    The proportion of patients needing ECMO in 30 days

  8. Mortality 1a [ Time Frame: at 30 days ]
    Time to in-hospital death censored

  9. Mortality 1b [ Time Frame: at 90 days ]
    Time to in-hospital death censored

  10. Mortality 2a [ Time Frame: at 30 days ]
    Proportion of patients with Survival status

  11. Mortality 2b [ Time Frame: at 90 days ]
    Proportion of patients with Survival status

  12. Care and Critical Care [ Time Frame: at 30 days ]
    Length of hospitalization and stay in the ICU

  13. organ systems: renal [ Time Frame: up to 365 days ]
    The proportion of patients needing renal replacement therapy

  14. organ systems: cardiac [ Time Frame: up to 365 days ]
    The proportion of patients developing myocarditis

  15. 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.

  16. Safety of the intervention [ Time Frame: up to 365 days ]
    cumulative incidence of severe and life-threatening AEs and severe AEs

  17. organ systems: multi-system inflammatory disease [ Time Frame: up to 365 days ]
    The proportion of patients developing multi-system inflammatory disease


Other Outcome Measures:
  1. Virological measures 1 [ Time Frame: at day 3 ]
    Proportion of patients with negative virology

  2. Virological measures 3 [ Time Frame: at day 10 ]
    Proportion of patients with negative virology

  3. Virological measures 4 [ Time Frame: at day 15 ]
    Proportion of patients with negative virology

  4. Modulation of biomarkers [ Time Frame: up to 365 days ]
    Exploratory analysis of biomarker differences between groups

  5. Resolution of fever [ Time Frame: hours ]
    Time to fever resolution (no longer requiring fever management)

  6. 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.

  7. Functional measure 1 [ Time Frame: up to 365 days ]
    efficacy of C19-CP on respiratory measures using pediatric validated dyspnea (breathlessness) scales

  8. 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)

  9. Functional measure 3 [ Time Frame: up to 365 days ]
    Evaluate the efficacy of C19-CP on rehospitalization after discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377568


Locations
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Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
Winnipeg Children's Hospital
Winnipeg, Manitoba, Canada, R3C 1X7
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Children's Hospital
London, Ontario, Canada, N6C 2V5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Canada, Quebec
CHU Sainte-Justine
Montréal, Quebec, Canada, H3T 1C5
McGill Univ Health Ctr - Montreal Children's Hospital
Montréal, Quebec, Canada, H4A 3J1
Canada, Saskatchewan
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
The Hospital for Sick Children
C17 Council (regulatory sponsor)
Investigators
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Study Chair: Julia Upton, MD, MPH The Hospital for Sick Children
Study Director: Kathy Brodeur-Robb C17 Council (regulatory sponsor)
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Responsible Party: Julia Upton, Staff Physician, Allergy and Immunology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT04377568    
Other Study ID Numbers: 1000070143
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julia Upton, The Hospital for Sick Children:
covid-19
hospitalized children
convalescent plasma therapy
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases