Covid-19 Infection Clinical Trial
— CONCOR-KIDSOfficial 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
Verified date | April 2021 |
Source | The Hospital for Sick Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 1, 2022 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Children's Hospital | Calgary | Alberta |
Canada | Stollery Children's Hospital | Edmonton | Alberta |
Canada | IWK Health Centre | Halifax | Nova Scotia |
Canada | McMaster Children's Hospital | Hamilton | Ontario |
Canada | Kingston Health Sciences Centre | Kingston | Ontario |
Canada | Children's Hospital | London | Ontario |
Canada | CHU Sainte-Justine | Montréal | Quebec |
Canada | McGill Univ Health Ctr - Montreal Children's Hospital | Montréal | Quebec |
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Canada | Jim Pattison Children's Hospital | Saskatoon | Saskatchewan |
Canada | The Hospital for Sick Children | Toronto | Ontario |
Canada | BC Children's Hospital | Vancouver | British Columbia |
Canada | Winnipeg Children's Hospital | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children | C17 Council (regulatory sponsor) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Virological measures 1 | Proportion of patients with negative virology | at day 3 | |
Other | Virological measures 3 | Proportion of patients with negative virology | at day 10 | |
Other | Virological measures 4 | Proportion of patients with negative virology | at day 15 | |
Other | Modulation of biomarkers | Exploratory analysis of biomarker differences between groups | up to 365 days | |
Other | Resolution of fever | Time to fever resolution (no longer requiring fever management) | hours | |
Other | Presence and titres levels | Presence and titres of IgG, IgA antibodies and neutralizing antibody titres in C19-CP group on the primary outcome and other outcomes. | at day 30 | |
Other | Functional measure 1 | efficacy of C19-CP on respiratory measures using pediatric validated dyspnea (breathlessness) scales | up to 365 days | |
Other | Functional measure 2 | Evaluate the efficacy of C19-CP on quality of life (QOL) measures using Validated QOL scores (Eq-5D) | up to 365 days | |
Other | Functional measure 3 | Evaluate the efficacy of C19-CP on rehospitalization after discharge | up to 365 days | |
Primary | 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) | at day 30 | |
Secondary | Combined mortality/intubation | Proportion of patients experiencing death in hospital (Yes/No) 30 days | at 30 day | |
Secondary | Respiratory status-1 | Proportion of patients experiencing Intubation (Yes/No) | at 30 days | |
Secondary | Respiratory status-2 | time to intubation | time from admission to intubation | |
Secondary | Respiratory status-3 | Mean number of ventilator-free days in 30 days | from admission to day 30 of hospitalization | |
Secondary | respiratory status -4 | Mean number of ventilator days in 30 days | from admission to day 30 of hospitalization | |
Secondary | 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 | from admission to day 30 of hospitalization | |
Secondary | respiratory status-6 | The proportion of patients needing ECMO in 30 days | at 30 days | |
Secondary | Mortality 1a | Time to in-hospital death censored | at 30 days | |
Secondary | Mortality 1b | Time to in-hospital death censored | at 90 days | |
Secondary | Mortality 2a | Proportion of patients with Survival status | at 30 days | |
Secondary | Mortality 2b | Proportion of patients with Survival status | at 90 days | |
Secondary | Care and Critical Care | Length of hospitalization and stay in the ICU | at 30 days | |
Secondary | organ systems: renal | The proportion of patients needing renal replacement therapy | up to 365 days | |
Secondary | organ systems: cardiac | The proportion of patients developing myocarditis | up to 365 days | |
Secondary | 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. | up to 365 days | |
Secondary | Safety of the intervention | cumulative incidence of severe and life-threatening AEs and severe AEs | up to 365 days | |
Secondary | organ systems: multi-system inflammatory disease | The proportion of patients developing multi-system inflammatory disease | up to 365 days |
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