Myeloproliferative Neoplasms (MPN) and COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 552
- 试验地点
- 44
- 主要终点
- pulmonary embolism (PE)
研究概览
简要总结
An increased risk of both venous and arterial thromboembolism was noted in reports from SARS-CoV-2-infected patients in China and has been confirmed in autopsy findings from patients who experienced sudden death. Myeloproliferative Neoplasms (MPNs), which encompass polycythemia vera, essential thrombocythemia and primary myelofibrosis, are thrombophilic disorders with a natural propensity to thrombosis that is fuelled by the intrinsic activation of inflammatory cytokines. It therefore follows that an underlying diagnosis of MPN may increase the risk of worse clinical outcomes and death during periods of active Covid-19 disease. This ambispective, observational study aims to elucidate the key factors which affect the clinical course of patients with MPN who develop Covid-19 disease.
详细描述
This is an European multicenter observational study that will include around 550 MPN patients with a confirmed diagnosis of Covid-19 will be followed for at least one month. Detailed information on the clinical characteristics of these patients and their disease outcomes will be retrospectively and prospectively collected in a specific eCRF, including MPN characteristics, treatment and comorbidities pre-Covid-19, time of Covid-19 diagnosis, drugs/device used for the treatment of Covid-19, any change in MPN therapy, antithrombotic prophylaxis employed during the period of infection and - for hospitalised patients only - key blood and laboratory parameters. A particular focus will be on exploring final outcomes for patients in this study, most notably the incidence of fatal and non-fatal thrombotic events. Statistical analyses will also be performed looking for any independent factors that can significantly predict patient outcomes after Covid-19 diagnosis.
Ultimately, this project will provide important insights into disease severity and progression in patients with MPN and Covid-19 and uncover the key clinical factors which drive outcomes and mortality. Results may help clinicians better understand how patient characteristics and management decisions can impact on disease trajectory when MPN and Covid-19 collide.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 MPN according to WHO criteria
- •Diagnosis of COVID-19 based by the positivity of oropharyngeal swab performed between 15 February 2020 up to 15 February 2022
- •Signed informed consent
排除标准
- 未提供
结局指标
主要结局
pulmonary embolism (PE)
时间窗: 2 and a half months
Incidence of cases of MPN patients with COVID-19 experiencing pulmonary embolism
次要结局
- fatal or non fatal thrombotic event(2 and a half months)
- invasive ventilation(2 and a half months)
- treatments and interventions applied for COVID-19(2 and a half months)
- Continuous Positive Airway Pressure (CPAP)(2 and a half months)
- admission in Intensive Care Unit (ICU)(2 and a half months)
- death(2 and a half months)
- treatments and interventions applied for MPN(2 and a half months)
- thrombotic events association to patients characteristic and treatments(2 and a half months)
- Mortality rate occurring in the single MPN phenotypes in relation to cytoreductive treatment(2 and a half months)
- MPN progression rate(2 and a half months)