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
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 26
- 主要终点
- Clinical recovery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Clinical recovery
时间窗: 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)
次要结局
- Combined mortality/intubation(at 30 day)
- Respiratory status-1(at 30 days)
- Respiratory status-2(time from admission to intubation)
- Respiratory status-3(from admission to day 30 of hospitalization)
- respiratory status -4(from admission to day 30 of hospitalization)
- respiratory status -5(from admission to day 30 of hospitalization)
- respiratory status-6(at 30 days)
- Mortality 1a(at 30 days)
- Mortality 1b(at 90 days)
- Mortality 2a(at 30 days)
- Mortality 2b(at 90 days)
- Care and Critical Care(at 30 days)
- organ systems: renal(up to 365 days)
- organ systems: cardiac(up to 365 days)
- Transfusion-associated adverse events (AE)(up to 365 days)
- Safety of the intervention(up to 365 days)
- organ systems: multi-system inflammatory disease(up to 365 days)
研究者
Julia Upton
Staff Physician, Allergy and Immunology
The Hospital for Sick Children