跳至主要内容
临床试验/NCT04420468
NCT04420468已完成不适用

Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children

Assistance Publique - Hôpitaux de Paris4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
4
主要终点
Acute myocarditis

研究概览

简要总结

The study objectives are to descript clinical, biological and echocardiographic features of an acute myocarditis in children in the context of COVID-19 and to identify the underlying mechanism : direct viral damage and/or inadequate host response risk.

详细描述

An unexpected increase of shock with fever in children suspected to be infect by the COVID-19 is observed. These children present with similar symptoms and seem to have similar clinical time course.

This unexpected phenomenon needs to be extensively described in order to further the knowledge of unusual COVID-19 presentation in children.

The study consists an extensive retrospective data collection from April 2020 till the end of the main SARS-Cov-2 outbreak, from medical file of children have exhibited acute myocarditis and cared in 4 pediatric intensive care units of Assistance Publique-Hôpitaux de Paris of Ile-de-France region.

The study objectives are to descript clinical, biological and echocardiographic features of an acute myocarditis in children in the context of COVID-19 and to identify the underlying mechanism : direct viral damage and/or inadequate host response risk.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age < 18 years
  • Admitted to PICU from April 2020
  • Presented with an acute myocarditis, fever and shock with a possible COVID-19 infection

排除标准

  • Age ≥ 18 years
  • Other etiologies of acute myocarditis than the COVID-19
  • Opposition expressed by the holders of parental authority

结局指标

主要结局

Acute myocarditis

时间窗: 7 days

Occurrence, description and time course of acute myocarditis

Multi-systemic inflammatory syndrome

时间窗: 7 days

Occurrence, description and time course of multi-systemic inflammatory syndrome, features of Kawasaki disease

Kawasaki disease

时间窗: 7 days

Occurrence, description and time course of features of Kawasaki disease

次要结局

  • Results of SARS-CoV-2(7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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