跳至主要内容
临床试验/NCT05075785
NCT05075785已完成不适用

National Epidemiological Cohort to Evaluate Covid-19 Respiratory Sequelae: a French Pneumologist Collaboration.

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 2,933 人开始时间: 2021年10月7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
2,933
试验地点
1
主要终点
desaturation during the "6 min walk test"

研究概览

简要总结

As the investigators need data on long term outcome of Covid-19, especially respiratory sequelae, a national cohort is required. To better evaluate the potential respiratory sequelae after SARS-CoV-2 infection, it is fundamental to include patients with different management at the acute phase of the Covid-19: ambulatory management, hospitalization in non ICU and in ICU units. That is why the investigators will conduct a national cohort study with all components of french pneumology which will give the investigators the opportunity to include patients in general hospital, in university hospital and in private structure. As it is a "real life" study, the investigators will include all patients who will have a consultation with a pneumologist for an evaluation 5 to 7 months after a Covid-19 infection whatever their acute disease management. The investigators will collect all available data on Covid-19 acute phase, on patients characteristics and comorbidities, on persistent symptoms after Covid-19, on exams results during the outcome evaluation (CT-scan, 6 min walk test, spirometry and DLCO, blood gas, VO2 max if realized).

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

  • adults, older than 18
  • SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) in nasopharyngeal swab in patients who are evaluated by a pneumologist 5 to 7 months after their Covid-19 disease

排除标准

  • patients for whom follow-up would be difficult owing to psychotic disorder
  • patients who have declined to participate.

结局指标

主要结局

desaturation during the "6 min walk test"

时间窗: at 7 months

DLCO alteration at 5 months after Covid-19 episode

时间窗: at 5 months

DLCO alteration at 7 months after Covid-19 episode

时间窗: at 7 months

Variation of vital capacity at 7 months after Covid-19 episode

时间窗: at 7 months

Variation of vital capacity at 5 months after Covid-19 episode

时间窗: at 5 months

次要结局

  • Variation of FEV1 spirometry parameters(at 7 months)
  • Variation of VC spirometry parameters(at 7 months)
  • Variation of FVC spirometry parameters(at 7 months)
  • Variation of DLCO spirometry parameters(at 7 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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