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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04377568 |
Recruitment Status :
Withdrawn
(no enrollment)
First Posted : May 6, 2020
Last Update Posted : April 23, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hospitalized Children Covid-19 Infection | Biological: Convalescent plasma (CP) | Phase 2 |
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 |

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.
|
- 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)
- 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
- Virological measures 1 [ Time Frame: at day 3 ]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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
Study Chair: | Julia Upton, MD, MPH | The Hospital for Sick Children | |
Study Director: | Kathy Brodeur-Robb | C17 Council (regulatory sponsor) |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
covid-19 hospitalized children convalescent plasma therapy |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |