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| Name | Class |
|---|---|
| C17 Council (regulatory sponsor) | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard of Care (SoC) | No Intervention | Participants will receive standard of care while being hospitalized for COVID-19. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Combined mortality/intubation | Proportion of patients experiencing death in hospital (Yes/No) 30 days | at 30 day |
| Respiratory status-1 | Proportion of patients experiencing Intubation (Yes/No) |
| Measure | Description | Time Frame |
|---|---|---|
| Virological measures 1 | Proportion of patients with negative virology | at day 3 |
| Virological measures 3 | Proportion of patients with negative virology |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Julia Upton, MD, MPH | The Hospital for Sick Children | Study Chair |
| Kathy Brodeur-Robb | C17 Council (regulatory sponsor) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital | Calgary | Alberta | T3B 6A8 | Canada | ||
| Stollery Children's Hospital |
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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.
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| at 30 days |
| Respiratory status-2 | time to intubation | time from admission to intubation |
| Respiratory status-3 | Mean number of ventilator-free days in 30 days | from admission to day 30 of hospitalization |
| respiratory status -4 | Mean number of ventilator days in 30 days | 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 | from admission to day 30 of hospitalization |
| respiratory status-6 | The proportion of patients needing ECMO in 30 days | at 30 days |
| Mortality 1a | Time to in-hospital death censored | at 30 days |
| Mortality 1b | Time to in-hospital death censored | at 90 days |
| Mortality 2a | Proportion of patients with Survival status | at 30 days |
| Mortality 2b | Proportion of patients with Survival status | at 90 days |
| Care and Critical Care | Length of hospitalization and stay in the ICU | at 30 days |
| organ systems: renal | The proportion of patients needing renal replacement therapy | up to 365 days |
| organ systems: cardiac | The proportion of patients developing myocarditis | 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. | up to 365 days |
| Safety of the intervention | cumulative incidence of severe and life-threatening AEs and severe AEs | up to 365 days |
| organ systems: multi-system inflammatory disease | The proportion of patients developing multi-system inflammatory disease | up to 365 days |
| at day 10 |
| Virological measures 4 | Proportion of patients with negative virology | at day 15 |
| Modulation of biomarkers | Exploratory analysis of biomarker differences between groups | up to 365 days |
| Resolution of fever | Time to fever resolution (no longer requiring fever management) | hours |
| 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 |
| Functional measure 1 | efficacy of C19-CP on respiratory measures using pediatric validated dyspnea (breathlessness) scales | up to 365 days |
| 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 |
| Functional measure 3 | Evaluate the efficacy of C19-CP on rehospitalization after discharge | up to 365 days |
| Edmonton |
| Alberta |
| T6G 2B7 |
| Canada |
| BC Children's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
| Winnipeg Children's Hospital | Winnipeg | Manitoba | R3C 1X7 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| McMaster Children's Hospital | Hamilton | Ontario | L8N 3Z5 | Canada |
| Kingston Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada |
| Children's Hospital | London | Ontario | N6C 2V5 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G1X8 | Canada |
| CHU Sainte-Justine | Montreal | Quebec | H3T 1C5 | Canada |
| McGill Univ Health Ctr - Montreal Children's Hospital | Montreal | Quebec | H4A 3J1 | Canada |
| Jim Pattison Children's Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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