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临床试验/NCT04505631
NCT04505631已完成不适用

Follow-up of Respiratory Sequelae of Patients Hospitalized With SARS-CoV-2: a Prospective Multicenter Observational Study

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace14 个研究点 分布在 1 个国家目标入组 332 人开始时间: 2020年6月10日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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