Predictive Clinical Response Factors in COVID-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Identify risk factors to build a prognostic score.
研究概览
简要总结
This is a monocentric retro-prospective observational study that will be conducted on all COVID19 positive patients hospitalized at the S. Gerardo Hospital in Monza.
详细描述
BACKGROUND:
The Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pandemic is severely testing the health systems of the most advanced countries. Clinicians are faced with a new pathology of an emerging virus. There is therefore an urgent need to collect real-time clinical data that informs about outcome predictive variables. Furthermore, there are currently no antiviral drugs approved for the treatment of SARS-CoV-2 infection, off-label therapies are being used with drugs already in use for other pathologies that have shown some efficacy in vitro, and some treatments obtained for compassionate use with other drugs that are being tested.
It is more than ever necessary to collect clinical practice data both retrospectively on the work done so far, and in a longitudinal perspective, and analyze them quickly to optimize current treatments and define protocols for the future. Having a good clinical data base also offers the possibility of collaborating with numerous international networks on translational research, which aims to correlate clinical data with virological and immunological data, aimed at the rapid identification of possible specific viral virulence factors, or particular immune structures of the guests who once again define the final clinical outcome.
STUDY DESIGN:
All COVID19 positive patients admitted to San Gerardo Hospital will be enrolled in the study.
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
- •Patients 18 years old or above
- •Diagnosis of SARS-CoV-2 pneumonia
排除标准
- •Explicit refusal to participate in the study
结局指标
主要结局
Identify risk factors to build a prognostic score.
时间窗: Until patient discharge from the hospital (approximately 1 year)
Identify the risk factors to build a prognostic score through which it is possible to define a stratification that immediately directs towards the right intensity of care.
Identify risk factors for intra-hospital mortality.
时间窗: Until patient discharge from the hospital (approximately 1 year)
Identify risk factors for intra-hospital mortality in patients admitted to the COVID + hospital wards of San Gerardo hospital.
次要结局
- Describe the anti-viral therapies used commonly in this emergency in terms of efficacy(Until patient discharge from the hospital (approximately 1 year).)
- Predictive factors for clinical status patients based on "Ordinal Scale for Clinical Improvement"(Until patient discharge from the hospital (approximately 1 year))
- Describe the anti-viral therapies used commonly used in this emergency in terms of safety(Until patient discharge from the hospital (approximately 1 year).)
- Predictive factors for the hospitalization duration.(Until patient discharge from the hospital (approximately 1 year))
- Monitor the clinical course of the disease in discharged patients.(12 month after discharge)