Observational Cohort Study on the Natural History of Hospitalized SARS-COV-2 Patients: the STORM Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,433
- 试验地点
- 1
- 主要终点
- Covid19 infection clinical evolution
研究概览
简要总结
This is an observational study. The aim is to describe the natural history and clinical evolution over time of hospitalized patients affected by Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-COV-2) infection, including the genetic pathology of the disease and improve therapeutic procedures.
详细描述
BACKGROUND:
As of the end of February 2020, the ASST of Monza, with its two hospital wards of Monza and Desio, has treated 1433 COVID+ patients, of which 507 have currently been discharged (35.4%) and 206 (14%) transferred to other Low-intensity care facilities.
The importance of observational studies is now known in many fields of medicine and the "real life" data produced have become an integral part of the authorization dossiers by the competent authorities to govern the introduction of new drugs: in particular, in a disease such as that from COVID-19 in which the absence of specific anti-viral therapies prevents an "ad hoc" cure, it becomes fundamental to identify and validate systems of stratification of the risk of fatal events, in order to optimize health intervention measures.
METHODS AND STUDY DESIGN:
The study protocol provides the collection of clinical, diagnostic and therapeutic and laboratory data consistent with the objectives of the study (CORE DATA SET) to which other specific protocols and relative data will connect (DATABASE "leaf"). The data collection will be performed on eCRF (RedCap platform) and the database will have the "stem and leaf" structure, compatible with WHO indications regarding pandemic data collection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Clinical and / or radiological diagnosis of lung infection with COVID-19;
- •Positive test for SARS-CoV-2 infection.
排除标准
- •Age less than 18 years
结局指标
主要结局
Covid19 infection clinical evolution
时间窗: Until patient discharge from the hospital (approximately 1 year)
Description over time of hospitalized patients suffering from SARS-COV-2 infection to better understand the pathogenesis of the disease and improve the controls and therapeutic procedures.
次要结局
- Risk factors for intra-hospital mortality(Until patient discharge from the hospital (approximately 1 year))
- The impact of a fragility index (IF)(Until patient discharge from the hospital (approximately 1 year))
- Prognostic score(Until patient discharge from the hospital (approximately 1 year).)
- The lung sequelae of SARS-COV-2 pneumonia(Until patient discharge from the hospital (approximately 1 year))
- Coagulation system anomalies(Until patient discharge from the hospital (approximately 1 year))
- The impact of the prone position on the oxygenation(Until patient discharge from the hospital (approximately 1 year))
- The accuracy of IF in elderly patients(Until patient discharge from the hospital (approximately 1 year))