Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 10
- 主要终点
- Hospital length of stay
研究概览
简要总结
The study is to provide reliable estimates of the effect of study treatment on hospital length of stay through to 28 days after randomisation.
The protocol describes an overarching trial design to provide reliable evidence on the efficacy of candidate therapies for children hospitalised with PIMS-TS. It is an adaptive pragmatic platform trial with an open-label randomisation.
New trial arms can be added as evidence emerges that other candidate therapeutics should be evaluated.
详细描述
In May 2020 a new COVID-associated inflammatory syndrome in children was identified, Paediatric Inflammatory Multisystem Syndrome - Temporally associated with SARS-CoV-2 (PIMS-TS). A rapid international consensus process identified the need to evaluate corticosteroids and intravenous immunoglobulin (IVIg) as initial therapies in PIMS-TS, and confirmed tocilizumab and anakinra as biological anti-inflammatory agents to be evaluated as a second line therapy.
This Swissped-Recovery trial is a sister trial to the RECOVERY international trial with the implementation of the study at Swiss study sites.
The protocol describes an overarching trial design to provide reliable evidence on the efficacy of candidate therapies for children hospitalised with PIMS-TS. It is an adaptive pragmatic platform trial with an open-label randomisation.
New trial arms can be added as evidence emerges that other candidate therapeutics should be evaluated.
Additional substudies can be added to provide more detailed information on side effects or sub-categorisation of patient types.
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
- 44 Weeks 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalised children (aged <18 years old)
- •SARS-CoV-2 infection associated disease (clinically suspected or laboratory confirmed) with evidence of single or multi-organ dysfunction (called Pediatric Multisystem Inflammatory Syndrome temporally associated with COVID-19 [PIMS-TS]).
- •No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial
排除标准
- •Neonates/infants with a corrected gestational age of <= 44 weeks
- •If the attending clinician believes that there is a specific contra-indication to one of the active drug treatment arms or that the patient should definitely be receiving one of the active drug treatment arms, then that arm will not be available for randomisation for that patient.
研究组 & 干预措施
Methylprednisolone sodium succinate 10 mg/kg
Methylprednisolone sodium succinate 10 mg/kg intravenously once daily for 3 days (max 1 g per dose)
干预措施: Methylprednisolone sodium succinate 10 mg/kg intravenously (Drug)
Human normal immunoglobulin (IVIg)
Human normal immunoglobulin (IVIg) 2g/kg intravenously as a single dose in line with guidance for dosing and administration in Kawasaki disease
干预措施: Human normal immunoglobulin (IVIg) (Biological)
结局指标
主要结局
Hospital length of stay
时间窗: Within 28 days after randomisation
effect of study treatment on hospital length of stay
次要结局
- All-cause mortality among patients(Within 28 days and up to 6 months after randomisation)
- Composite endpoint of death or need for mechanical ventilation or extracorporeal membrane oxygenation (ECMO)(Within 28 days and up to 6 months after randomisation)