Risk Factors and Prognoses in Patients Hospitalized for COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 971
- 试验地点
- 2
- 主要终点
- Composite endpoint (death, initiation of mechanical ventilation, ICU admission and thrombotic event)
研究概览
简要总结
Multicenter and observational study. The study will include patients admitted to hospitals in the Lleida health region with confirmed COVID-19. Follow-up will be carried out up to six months after hospital discharge.
Through the analysis of clinical data and biological parameters, it is possible to identify in advance patients who will evolve in an unfavorable prognosis in relation to COVID-19, either because they present criteria of severe disease or because they present thrombotic complications associated with the disease. The final aim is to make anticipated and individualized therapeutic decisions that reduce the morbidity and mortality associated with the disease.
详细描述
The main objective is to develop a predictive model of adverse events in hospitalized COVID-19 patients (death, initiation of mechanical ventilation, ICU admission and thrombotic event). An additional analyses will be performed for each individualized outcome.
Metodology: Prospective case-only study. The variables that will be collected are:
- Previous epidemiological data of the patient.
- Clinical and biological data and treatment upon admission to the hospital.
- Clinical and biological evolutionary data (Increases in the values of certain biological variables in a defined period of time (> 48 h) during admission):
- Baseline epidemiological and clinical variables
- Baseline biological variables
- Complications and clinical evolutionary variables
- Evolutionary biological variables
- Clinical evolutionary data of final outcomes, including death (at 30, 90 days and at 6 months), initiation of mechanical ventilation, ICU admission and thrombotic event.
- For future studies of new biological and epigenetic variables, blood samples will be collected from hospitalized patients under the CIBER coverage.
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
- •Laboratory confirmed COVID-19 infection.
- •Hospitalization in a center in the Lleida healthcare region.
排除标准
- •Patients admitted with repeatedly negative COVID-19 test results.
结局指标
主要结局
Composite endpoint (death, initiation of mechanical ventilation, ICU admission and thrombotic event)
时间窗: 18 months
Development of a predictive model of adverse events (death, initiation of mechanical ventilation, ICU admission and thrombotic event).
次要结局
- Death(18 months)
- Mechanical ventilation(18 months)
- ICU admission(18 months)
- Thrombotic event(18 months)
研究者
Ferran Barbe
Chair Respiratory Medicine
Sociedad Española de Neumología y Cirugía Torácica