SequelaeCov: a Prospective Study on Lung Damage Caused by SARS-CoV-2 Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Reduction of Diffusion of Lung CO (DLCO, single breath technique)
研究概览
简要总结
Pneumonia is a recurrent element of COVID-19 infection, it is often associated with development of respiratory failure and patients frequently need various degrees of oxygen therapy up to non invasive ventilation (NIV-CPAP) and invasive mechanical ventilation (IMV).
Main purpose of this study is to evaluate with non invasive clinical instruments (pletysmography, Diffusion lung capacity for carbon monoxide -DLCO-, six minute walking test and dyspnea scores) and radiological tools (chest X-ray and chest CT scan) the development of medium-to-long term pulmonary sequelae caused by SARS-CoV-2 pneumonia.
详细描述
SARS-CoV-2 related disease started in December 2019 in the Chinese city of Wuhan, rapidly spread and became an international health emergency.
Pneumonia is a frequent element of COVID-19, its pathogenic mechanisms are not entirely known and some patients develop various degrees of respiratory failure and need oxygen therapy up to NIV-CPAP) and IMV.
Some pathology studies in COVID-19 pneumonia show ARDS-like lesions associated to inflammatory reaction. It is known that pulmonary inflammatory damage can lead to fibrotic sequelae or to the development of pulmonary emphysema.
The main target of the study is to use non invasive methods (pletysmography, DLCO assessment, six minute walking test and dyspnea scores) and radiological tools (chest X-ray and chest CT scan) to identify pulmonary sequelae in patients hospitalised because of respiratory failure in COVID-19 pneumonia.
Study design: multicentre observational cohort study. Patients will be divided in three arms according to maximum ventilatory/oxygen support received during hospital stay:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 80 years
- •Able to sign informed consent to participate in the study
- •Real time PCR diagnosis od SARS-CoV-2 infection
- •Hospital admission due to clinical/instrumental diagnosis of interstitial pneumonia
- •Presence of acute respiratory failure (PaO2/FiO2 <300 mm Hg) at the moment of hospital admission
排除标准
- •Severe renal failure defined as glomerular filtration rate (GFR) < 30 ml/min at hospital discharge
- •Cardiovascular failure NYHA class IV (patient unable to perform any activity) at hospital discharge
- •Active solid or hematological malignancies at hospital discharge
- •Prior diagnosis of chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, bronchiectasis associated or not associated to cystic fibrosis
- •Pregnancy or breastfeeding
- •Suspected bacterial or fungine pulmonary superinfection during hospital stay
结局指标
主要结局
Reduction of Diffusion of Lung CO (DLCO, single breath technique)
时间窗: T2 at 12 months from discharge
Reduction below 80% of predicted values of DLCO
次要结局
- Alterations in 6 minute walking test (6MWT)(T2 at 12 months from discharge)
- Alterations of pletismography(T2 at 12 months from discharge)
- Alterations of Arterial Blood Gas Analysis(T2 at 12 months from discharge)
- Abnormal Dyspnea Score(T2 at 12 months from discharge)
- Presence and extension of abnormal pulmonary lung sounds at auscultation(T2 at 12 months from discharge)
- Presence and extension of radiological alterations at chest X-ray(T1 at 6 months from discharge)
- Presence and extension of radiological alterations at chest CT scan(T2 at 12 months from discharge)