Observational Study of the Impact of the COronaVirus Disease 2019 (COVID-19) Epidemic on Patients With Myeloproliferative Neoplasias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,793
- 试验地点
- 1
- 主要终点
- Rate of death of MNP patients who had COVID-19
研究概览
简要总结
The classic myeloproliferative neoplasias (MNP), including polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF) or secondary to PV or ET, are among the most frequent of malignant hemopathies, with overall prevalence estimated at around 10,000 patients followed in France. Due to the median age of patients around 65, the frequency of cardiovascular complications of these thrombogenic diseases and the impact of cytoreductive treatments on immune cells, these patients are considered to be at risk of developing forms severe of COVID-19. This study will assess the impact of MNPs on the risk of developing a severe form of COVID-19, identify new risk factors linked to the disease as well as the impact of treatments for MNPs according to their pharmacological class.
详细描述
It is a descriptive, prospective epidemiological study using retrospective patient data, multicenter, non-interventional, carried out in FIM (French Intergroup of Myeloproliferative syndromes) / FILO (French Innovative Leukemia Organization) centers.
This is an exploratory descriptive study in order to put in place as soon as possible a possible strategy for the protection of patients most at risk.
The study will include all consecutive patients with MNP according to the WHO (World Health Organization) classification seen in consultation or teleconsultation over the duration of the study, whether or not they have had a COVID-19 infection.
The collection of clinical data, treatment regimens and survival and death data will be carried out by the investigator or a member of his medical team, after delivering an information note to the patient informing him of the computerized processing of his data, subject to the patient's non-objection.
The diagnosis of asymptomatic COVID 19 will be made on the presence of a positive serology and on the absence of clinical signs on questioning.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with PV, ET, PMF or MF secondary to PV or ET diagnosed before the COVID-19 pandemic
- •Seen in consultation or teleconsultation from May 2020 or deceased if the investigator became aware of this death during the study period
排除标准
- •Refusal to participate in the study
结局指标
主要结局
Rate of death of MNP patients who had COVID-19
时间窗: Through study completion, an average of 1 year
Number of MNP patients who died from COVID-19
Rate of passages in intensive care with need for mechanical ventilation
时间窗: Through study completion, an average of 1 year
Number of MNP patients hospitalized in intensive care with need for mechanical ventilation
Rate of serious coronavirus infection in different MNP patient subgroups
时间窗: Through inclusion period, an average of 6 months
The crude rate of cumulative incidence of serious infection proven to COVID-19, compared to the population of the same age, same sex, same region of residence during the epidemic period.
Proportion of MNP patients who had COVID-19 infection during the 2020 epidemic.
时间窗: Through inclusion period, an average of 6 months
Number of MNP patients who had COVID-19 compared to general population in France
次要结局
未报告次要终点