SARS-COV-2 (virus Responsible of COVID-19) Reinfection and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk: Matched Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- proportion of MIS-C cases occurred after first SARS-CoV-2 infection
研究概览
简要总结
This study is a multicenter, international, non interventional, retrospective study about SARS-CoV-2 and Multisystem Inflammatory Syndrome (MIS-C) reinfection risk in children.
详细描述
This study is based to data collection of cases (patients with MIS-C) compare to controls (patients with SARS-CoV-2 infection) occurring between 01 sep 2021 and 30 apr 2022. For this study cases and controls group will be matched for analyses.
The main of this study is to evaluate the difference of risk of occurrence of MIS-C between a first SARS-CoV-2 infection and a reinfection with SARS-CoV-2.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •group 1: cases
- •Patients with MIS-C (following SARS CoV-2 infection)
- •Hospitalised between the 01 sep 2021 and 30 apr 2022
- •Under 18 years of age
- •Not vaccinated for SARS-CoV-2
- •group 2: controls
- •Patients not hospitalised, treated by outpatient care
- •With documented SARS-CoV-2 infection between the 01 sep 2021 and 30 apr 2022
- •Matched with a case on age (+/- 6 months), gender and country
- •Not vaccinated for SARS-CoV-2
排除标准
- •Refusal to participate by patient relative or legal representative
结局指标
主要结局
proportion of MIS-C cases occurred after first SARS-CoV-2 infection
时间窗: 8 months
Assessment of risk of MIS-C after first SARS-CoV-2 infection
proportion of MIS-C cases occurred after SARS-CoV-2 reinfection
时间窗: 8 months
Assessment of risk of MIS-C after SARS-CoV-2 reinfection
Proportion of SARS-CoV-2 reinfection after first SARS-CoV-2 infection
时间窗: 8 months
Assessment of risk of SARS-CoV-2 reinfection after first SARS-CoV-2 infection
次要结局
未报告次要终点