Hospitalized ChildrenPhase 2CONCOR-KIDSNCT04377568
Efficacy of Human Coronavirus-immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children
A Phase 2 study testing Convalescent plasma (CP) in people with Hospitalized Children and Covid-19 Infection, run by The Hospital for Sick Children at 13 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hospitalized Children, Covid-19 Infection
- What is being tested?
- Convalescent plasma (CP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 13 sitesCanada
- Study dates
- 7 Oct 2020to 1 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Children's Hospital
London, Ontario, N6C 2V5
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
McGill Univ Health Ctr - Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, S7N 0W8
The Hospital for Sick Children
Toronto, Ontario, M5G1X8
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4
Winnipeg Children's Hospital
Winnipeg, Manitoba, R3C 1X7
About this study
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
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.
Read the 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.
- Conditions
- Hospitalized Children, Covid-19 Infection
- Being tested
- Convalescent plasma (CP)
- Keywords
- covid-19, hospitalized children, convalescent plasma therapy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent plasma (CP)Biological
Participants will receive one infusion of convalescent plasma proportional to their weight (10 mL/kg), up to a maximum of 500 mL
| Study group | Role | What they receive |
|---|---|---|
| Convalescent Plasma + Standard of Care (C19-CP + SoC) | Experimental | Participants will receive COVID-19 convalescent plasma (C19-CP) plus standard of care while being hospitalized for COVID-19. Receives: Biological: Convalescent plasma (CP) |
| Standard of Care (SoC) | No intervention | Participants will receive standard of care while being hospitalized for COVID-19. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at day 30
Secondary outcomes (17)
Combined mortality/intubation
Proportion of patients experiencing death in hospital (Yes/No) 30 days
Measured: at 30 day
Respiratory status-1
Proportion of patients experiencing Intubation (Yes/No)
Measured: at 30 days
Respiratory status-2
time to intubation
Measured: time from admission to intubation
Respiratory status-3
Mean number of ventilator-free days in 30 days
Measured: from admission to day 30 of hospitalization
respiratory status -4
Mean number of ventilator days in 30 days
Measured: from admission to day 30 of hospitalization
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
Measured: from admission to day 30 of hospitalization
respiratory status-6
The proportion of patients needing ECMO in 30 days
Measured: at 30 days
Mortality 1a
Time to in-hospital death censored
Measured: at 30 days
Mortality 1b
Time to in-hospital death censored
Measured: at 90 days
Mortality 2a
Proportion of patients with Survival status
Measured: at 30 days
Mortality 2b
Proportion of patients with Survival status
Measured: at 90 days
Care and Critical Care
Length of hospitalization and stay in the ICU
Measured: at 30 days
organ systems: renal
The proportion of patients needing renal replacement therapy
Measured: up to 365 days
organ systems: cardiac
The proportion of patients developing myocarditis
Measured: up to 365 days
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.
Measured: up to 365 days
Safety of the intervention
cumulative incidence of severe and life-threatening AEs and severe AEs
Measured: up to 365 days
organ systems: multi-system inflammatory disease
The proportion of patients developing multi-system inflammatory disease
Measured: up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start7 Oct 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 May 2022 (estimated)
Why it stopped: no enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalized ChildrenStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- C17 Council (regulatory sponsor)
- Responsible party
- Principal investigator, Julia Upton, The Hospital for Sick Children
- Investigators
- Julia Upton, MD, MPH, Study chair, The Hospital for Sick ChildrenKathy Brodeur-Robb, Study director, C17 Council (regulatory sponsor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377568
- Sponsor's protocol ID
- 1000070143
- Acronym
- CONCOR-KIDS
- Status last verified
- Apr 2021
- First submitted
- 30 Apr 2020
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04377568
- Acronym / sponsor ID
- CONCOR-KIDS / 1000070143
- Conditions
- Hospitalized Children, Covid-19 Infection
- Keywords
- covid-19, hospitalized children, convalescent plasma therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- C17 Council (regulatory sponsor)
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Convalescent Plasma + Standard of Care (C19-CP + SoC) | Experimental | Biological: Convalescent plasma (CP)Participants will receive COVID-19 convalescent plasma (C19-CP) plus standard of care while being hospitalized for COVID-19. |
| Standard of Care (SoC) | No intervention | –Participants will receive standard of care while being hospitalized for COVID-19. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | Convalescent Plasma + Standard of Care (C19-CP + SoC) |
Primary outcome
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)
17 secondary outcomes
Combined mortality/intubation
Time frame: at 30 day
Respiratory status-1
Time frame: at 30 days
Respiratory status-2
Time frame: time from admission to intubation
Respiratory status-3
Time frame: from admission to day 30 of hospitalization
respiratory status -4
Time frame: from admission to day 30 of hospitalization
respiratory status -5
Time frame: from admission to day 30 of hospitalization
respiratory status-6
Time frame: at 30 days
Mortality 1a
Time frame: at 30 days
Mortality 1b
Time frame: at 90 days
Mortality 2a
Time frame: at 30 days
Mortality 2b
Time frame: at 90 days
Care and Critical Care
Time frame: at 30 days
organ systems: renal
Time frame: up to 365 days
organ systems: cardiac
Time frame: up to 365 days
Transfusion-associated adverse events (AE)
Time frame: up to 365 days
Safety of the intervention
Time frame: up to 365 days
organ systems: multi-system inflammatory disease
Time frame: up to 365 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Upton, MD, MPH study chair
The Hospital for Sick Children
Kathy Brodeur-Robb study director
C17 Council (regulatory sponsor)
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Convalescent plasma (CP) in people with Hospitalized Children and Covid-19 Infection, run by The Hospital for Sick Children at 13 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical recovery (time frame: at day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.