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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
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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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Study Start Date : July 15, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : May 1, 2022

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Arms and Interventions
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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.


Outcome Measures
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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 2 [ Time Frame: at day 5 ]
    Proportion of patients with negative virology

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

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

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

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

  7. 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.

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

  9. 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)

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


Eligibility Criteria
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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.

Contacts and Locations
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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


Contacts
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Contact: Julia Upton 416 813 7654 ext 208634 julia.upton@sickkids.ca
Contact: Christoph Licht christoph.licht@sickkids.ca

Locations
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Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Contact: Tammie Dewan    403-955-2251    tammie.dewan@ahs.ca   
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Contact: Ari Joffe    780-904-5003    ari.joffe@ahs.ca   
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Kyla Hildebrand    604-875-2118    kyla.hildebrand@cw.bc.ca   
Canada, Manitoba
Winnipeg Children's Hospital
Winnipeg, Manitoba, Canada, R3C 1X7
Contact: Sergio Fanella    204-789-3619    Sergio.fanella@umanitoba.ca   
Contact: Geoff Cuvelier Cuvelier    204-787-8689    gcuvelier@cancercare.mb.ca   
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Karina Top    902-470-6343    karina.top@dal.ca   
Canada, Ontario
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Carol Portwine    905 521-2100 ext 73440    portwc@mcmaster.ca   
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Contact: Kirk Leifso    613-549-6666 ext 4088    Kirk.leifso@kingstonhsc.ca   
Children's Hospital
London, Ontario, Canada, N6C 2V5
Contact: Nancy Nashid    289-684-3659    nancy.nashid@lhsc.on.ca   
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Contact: Anne Pham-Huy    613 737-7600 ext 2651    aphamhuy@cheo.on.ca   
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Contact: Peter Gill, MD    4168137654 ext 208634    peter.gill@sickkids.ca   
Canada, Quebec
CHU Sainte-Justine
Montréal, Quebec, Canada, H3T 1C5
Contact: Julie Autmizguine    514-345-4931 ext 5566    julie.autmizguine@umontreal.ca   
McGill Univ Health Ctr - Montreal Children's Hospital
Montréal, Quebec, Canada, H4A 3J1
Contact: Jesse Papenburg    514 412-4400    jesse.papenburg@mail.mcgill.ca   
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Rupeena Purewal    306-844-1249    rupeena.purewal@saskhealthauthority.ca   
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)
More Information
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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: June 25, 2020
Last Verified: June 2020

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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