Follow-up of Respiratory Sequelae of Patients Hospitalized With SARS-CoV-2: a Prospective Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 332
- 试验地点
- 14
- 主要终点
- Presence of respiratory sequelae
研究概览
简要总结
The objective of this multicenter observational study is to describe respiratory sequelae of COVID-19 patients hospitalized for severe pneumonia requiring oxygen supply.
详细描述
Main objective To assess respiratory sequelae after SARS-CoV-2 infection in hospitalized patients with severe pneumonia requiring oxygen supply and followed up for 6 months after hospital discharge (see primary and secondary outcomes).
Secondary objectives
To describe pulmonary sequelae according to :
- the unit in which the patient was hospitalized,
- the maximum oxygen flow rate required during hospitalization,
- McCabe score,
- age,
- tobacco consumption,
- biological data (e.g. blood count, CRP, fibrinogen, LDH, albumin, D-dimer, ferritin),
- number of days from onset of symptoms to hospitalization,
- co-morbidities (e.g. diabetes, hypertension, coronary artery disease/heart failure, mild to moderate COPD/respiratory failure, overweight),
- concomitant treatments (e.g. non-steroidal anti-inflammatory drugs, corticosteroids, immunosuppressants, ACE inhibitors)
- specific drug treatments administered to treat COVID-19 infection,
- non-drug treatments (invasive ventilation, non-invasive ventilation, postural treatment) to manage respiratory disorders of COVID-19 infection.
To assess the impact of factors of social inequality on the severity of COVID-19 infection.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Presence of respiratory sequelae
时间窗: 6 months after hospital discharge
The presence of respiratory sequelae will be assessed by low dose thoracic tomodensitometry
次要结局
- RV/TLC ratio (%)(3 months after hospital discharge)
- Arterial oxygen partial pressure (PaO2, mmHg)(3 months after hospital discharge)
- Forced vital capacity (FVC, %)(3 months after hospital discharge)
- Forced expiratory volume in 1 second (FEV1, %)(3 months after hospital discharge)
- Tiffeneau-Pinelli index (FEV1/FVC, %)(3 months after hospital discharge)
- Diffusion capacity of the lungs for carbon monoxide (DLCO, %)(3 months after hospital discharge)
- pH(3 months after hospital discharge)
- Bicarbonate concentration (mmol/L)(3 months after hospital discharge)
- Six-minute walk test(3 months after hospital discharge)
- Presence of respiratory sequelae on low dose thoracic tomodensitometry(3 months after hospital discharge)
- Total lung capacity (TLC, %)(3 months after hospital discharge)
- Maximal expiratory pressure (MEP, %)(3 months after hospital discharge)
- Arterial oxygen saturation (SaO2, %)(3 months after hospital discharge)
- Residual volume (RV, %)(3 months after hospital discharge)
- Maximal inspiratory pressure (MIP, %)(3 months after hospital discharge)
- Arterial carbon dioxide partial pressure (PaCO2, mmHg)(3 months after hospital discharge)
