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临床试验/NCT04735588
NCT04735588Unknown不适用

IMMUNE THROMBOCYTOPENIA (ITP) AND COVID-19: National Retrospective and Prospective Observational Investigation on the Incidence and Course of COVID-19 in Patients With Prior, Ongoing or de Novo ITP. Evaluation of the Impact of COVID-19 Pandemic on the Management of ITP

Gruppo Italiano Malattie EMatologiche dell'Adulto8 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年8月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
140
试验地点
8
主要终点
Number of COVID-19 patients developing ITP

研究概览

简要总结

Multicenter retrospective and prospective observational study based on the collection of sequential anonymized data from principal Italian ITP centers, to describe the clinical course of ITP patients becoming infected by SARS-CoV-2 and of COVID-19 patients developing de novo ITP.

详细描述

Multicenter retrospective and prospective observational study based on the collection - through pre-piloted electronic CRFs - of sequential anonymized data from principal Italian ITP centers representative of national geographical distribution, to evaluate, during a 2-years study period, both the cumulative incidence COVID-19 occurring in patients with prior or ongoing ITP (COVID-19 in ITP) and the cumulative incidence of de novo ITP manifesting during COVID-19 (ITP in COVID-19). Data will be collected to describe the clinical course of patients in the two groups. The enrolment period will last 24 months or terminate at the last day of 1-month-COVID-19 free in Italy, whichever comes first. Each patient will be followed up to the first visit scheduled as per common center practice, including at least six months after hospital discharge or end of quarantine home confinement.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Confirmed diagnosed of ITP (ITP could be past, ongoing, persistent >3 months, chronic >12 months) in patients that are in regular follow-up (at least once a year) and who have been diagnosed with COVID-19
  • All patients who develop de novo ITP from 1st January 2020 to the end of study after a diagnosis of COVID-19 or during the first 6 months after COVID-19 recovery
  • Signed informed consent

排除标准

  • All subjects not fitting inclusion criteria

结局指标

主要结局

Number of COVID-19 patients developing ITP

时间窗: 24 months

Cumulative incidence of adult patients with COVID-19 developing de novo ITP

Number of ITP patients in which COVID-19 occurs

时间窗: 24 months

Cumulative incidence of COVID-19 in adult patients with already known/ongoing ITP

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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