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
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
- 否
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
