Efficacy of Human Coronavirus-immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children
- Conditions
- Hospitalized ChildrenCovid-19 Infection
- Interventions
- Biological: Convalescent plasma (CP)
- Registration Number
- NCT04377568
- Lead Sponsor
- The Hospital for Sick Children
- 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Convalescent Plasma + Standard of Care (C19-CP + SoC) Convalescent plasma (CP) Participants will receive COVID-19 convalescent plasma (C19-CP) plus standard of care while being hospitalized for COVID-19.
- Primary Outcome Measures
Name Time Method Clinical recovery 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
Name Time Method Respiratory status-2 time from admission to intubation time to intubation
Combined mortality/intubation at 30 day Proportion of patients experiencing death in hospital (Yes/No) 30 days
Respiratory status-1 at 30 days Proportion of patients experiencing Intubation (Yes/No)
Respiratory status-3 from admission to day 30 of hospitalization Mean number of ventilator-free days in 30 days
respiratory status -4 from admission to day 30 of hospitalization Mean number of ventilator days in 30 days
respiratory status -5 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 at 30 days The proportion of patients needing ECMO in 30 days
Mortality 1a at 30 days Time to in-hospital death censored
Mortality 1b at 90 days Time to in-hospital death censored
Mortality 2a at 30 days Proportion of patients with Survival status
Mortality 2b at 90 days Proportion of patients with Survival status
Care and Critical Care at 30 days Length of hospitalization and stay in the ICU
organ systems: renal up to 365 days The proportion of patients needing renal replacement therapy
organ systems: cardiac up to 365 days The proportion of patients developing myocarditis
Transfusion-associated adverse events (AE) 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 up to 365 days cumulative incidence of severe and life-threatening AEs and severe AEs
organ systems: multi-system inflammatory disease up to 365 days The proportion of patients developing multi-system inflammatory disease
Trial Locations
- Locations (13)
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Stollery Children's Hospital
🇨🇦Edmonton, Alberta, Canada
BC Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
CHU Sainte-Justine
🇨🇦Montréal, Quebec, Canada
McGill Univ Health Ctr - Montreal Children's Hospital
🇨🇦Montréal, Quebec, Canada
Winnipeg Children's Hospital
🇨🇦Winnipeg, Manitoba, Canada
Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
McMaster Children's Hospital
🇨🇦Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Jim Pattison Children's Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Children's Hospital
🇨🇦London, Ontario, Canada