Assessment of Post COVID-19 Manifestations in a Multicenter Cohort Study (EuCARE-POSTCOVID Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,300
- 试验地点
- 7
- 主要终点
- Overall incidence of post COVID-19 condition
研究概览
简要总结
The EuCARE-POSTCOVID study is an observational multicentre study enrolling COVID-19 patients recovered from the acute phase of disease to investigate the prevalence and possible predictors of post COVID-19 condition. The study will retrospectively analyze data already collected at the post COVID-19 outpatients services of the participating centers; furthermore, a prospective cohort study will be performed.
详细描述
Background:
The EuCARE project includes several cohorts of patients and schools to provide an advance response to COVID-19 epidemics. The cohorts belong to different geographic areas including European countries, Kenya, Mexico, Russia and Vietnam, and will consolidate or expand interactions with other cohorts. A comprehensive multidisciplinary team of clinicians, virologists, epidemiologists, statisticians and top experts in artificial intelligence will collaborate to investigate:
- the natural and artificial immunity to the different viral variants in health care workers;
- the clinical course and long-term follow up of hospitalized COVID-19 patients to derive the role of different viral variants in the outcome of the infection, including post COVID-19 condition;
- the best strategies to control the spread of different viral variants in schools, by comparing the outcome of diverse containment and prevention measures in relation to the prevalence and dynamics of the variants.
Post COVID-19 condition is defined as the persistence or new onset of symptoms 3 months after an acute episode of COVID-19; these symptoms could last 2 or even more months and are not explained by an alternative diagnosis. The prevalence of these ongoing symptoms is very variable among the different studies, but seems high, affecting up to 50-60% of recovered patients.
Moreover, the post COVID-19 condition is described more commonly in females and more severe patients, but can be observed at all ages and in patients with a mild acute episode of COVID-19 disease.
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
- •Adult patients, >18 years old;
- •Confirmed diagnosis of COVID-19 disease (positive SARS CoV-2 RNA on naso- pharyngeal swab or upper respiratory sample);
- •Mild COVID-19 disease without hospital admission or moderate/severe disease requiring hospital admission for COVID-19 or hospitalization for other medical issues with a positive SARS CoV-2 RNA sample;
- •Informed consent for the study.
排除标准
- •death during hospitalization:
- •patient's decline to participate in the study.
结局指标
主要结局
Overall incidence of post COVID-19 condition
时间窗: through study completion, an average of 3 years
Persistence of post COVID-19 condition beyond 2-3 months from the acute COVID-19 disease
时间窗: through study completion, an average of 3 years
Predictors of post COVID-19 condition
时间窗: through study completion, an average of 3 years
Long-term organ damage (lung, heart, Central Nervous System, Peripheral Nervous System) associated with post COVID-19 condition
时间窗: through study completion, an average of 3 years
Virological and immunological phenotype of post COVID-19 condition
时间窗: through study completion, an average of 3 years
次要结局
未报告次要终点