Acute Respiratory Failure and Continuous Positive Airway Pressure Therapy in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: a Real Life Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
研究概览
简要总结
In December 2019 a new kind of virus was identified in China as the responsible of severe acute respiratory syndrome (SARS) and interstitial pneumonia. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quickly spread around the world and in February 2020 became a pandemia in Europe.
No pharmacological treatment is actually licensed for the SARS-CoV2 infection and at the current state of art there is a lack of data about the clinical management of the coronavirus 2019 disease (COVID-19).
The aim of this observational study is to collect the data and the outcomes of COVID-19 patients admitted in the H. Sacco Respiratory Unit treated according to the Standard Operating Procedures and the Good Clinical Practice.
详细描述
All consecutive adult COVID-19 patients admitted to our Respiratory Unit will be enrolled. All demographic, anthropometric, laboratory, radiological, clinical and microbiological data will be collected and analyzed according to the primary and secondary outcomes (see the dedicated section).
During the hospitalization, patients will be treated according to the standard operating procedure of our Respiratory Unit, such as arterial gas analysis, Rx, pharmacological treatment, ventilation. This study is purely observational and no randomization will be performed.
After discharge, patients a 7 days, 30 days and 6 months follow up will be assessed.
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
- •Patients that can give written or oral informed consent
- •patients with microbiological diagnosis (i.e. rhinopharyngeal swab) of SARS-CoV2 infection
排除标准
- •severe cognitive impairment
- •absolute contraindication to non invasive ventilation or cpap therapy
- •rhinopharyngeal swab negative for SARS-CoV2
研究组 & 干预措施
Coronavirus Infection
All patients admitted to the Respiratory Unit with SARS-CoV-2 infection and respiratory failure
干预措施: standard operating procedures (Other)
结局指标
主要结局
Real life data of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
时间窗: 1-6 months
Data collection about the real life management of patients affected by SARS-CoV-2 infection with acute respiratory distress syndrome
次要结局
- Recurrence rate(1 month)
- Risk factor for COVID19(retrospective)
- Ultrasound findings(1 month)
- 6 months mortality(6 months)
- Time to Intubation(7 days)
- Non invasive to Invasive time(7 days)
- in-hospital mortality(1 month)
- Coinfections(1 month)
- Medical management(1 month)
- Recovery rate(1 month)
- Antiviral therapy(1 month)
- 30 days mortality(1 month)
- Intubation rate(7 days)
- Time to ventilation(7 days)
- Blood tests and outcome(1 month)
- Myocardial injury(1 month)
- Radiological findings(1 month)
研究者
Pierachille Santus, MD, PhD
Professor, Head of Respiratory Disease Unit H sacco
University of Milan