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临床试验/NCT04934202
NCT04934202Unknown不适用

Cohort Follow-up at 6-12 Months of Survivors of Hospitalization for COVID-19 During the 2nd Wave of the Epidemic From a University Hospital in France

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年5月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
Prevalence of respiratory, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19.

研究概览

简要总结

From July to September 2020, in a first uncontrolled cohort study, 478 patients who were hospitalized at Bicêtre hospital for COVID-19 and who survived were evaluated at 4 months (publication accepted at JAMA). The current project aims to bring together the means to continue this work during the 2nd epidemic wave.

详细描述

From 15th July to 18th September, 2020, in a first uncontrolled cohort study (Multi-Expertise Consultation of Bicêtre After Covid-19, COMEBAC), we evaluated at four months the surviving patients who were hospitalized at the Bicêtre hospital for COVID-19 during the 1st wave of the epidemic in France and having survived this hospitalization. This cohort included 478 patients. The article resulting from the analysis of the data collected is accepted for publication in JAMA.

This evaluation, the aim of which was both clinical and scientific, was carried out largely thanks to human and material resources then demobilized because of the epidemic and thanks to the investment of doctors and psychologists who carried out the work in addition to their usual work.

The response to the current call for projects aims to bring together the means to continue this monitoring work during the 2nd epidemic wave, while the means and staff are this time completely mobilized by the care of patients with COVID-19 and other. It also aims to raise funds that will allow an in-depth analysis of the residual symptoms presented by the patients.

The current project aims to continue the work started with the COMEBAC "1st wave" cohort with:

  • The inclusion of patients hospitalized after the 1st wave.
  • An assessment of symptoms according to the SARS-CoV-2 variant.
  • A 12-month follow-up of symptomatic patients during the evaluation in COMEBAC "1st wave".

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

Prevalence of respiratory, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19.

时间窗: 6 months

nature and prevalence of symptoms persisting at 6 months of an episode of COVID-19 requiring hospitalization

次要结局

  • Association between residual symptoms and the type of SARS-CoV-2 variant(6 months)
  • Prevalence of respiratory, neurological, cognitive and psychological symptoms presented at 6 months of hospitalization for COVID-19 which occurred during the 1st epidemic wave.(6 months)
  • Association between patient characteristics and the prevalence of residual symptoms.(6 months)
  • Difference between the prevalence of residual symptoms between patients hospitalized during the 1st wave of the epidemic in France (from the COMEBAC "1st wave" study) and those of the current study(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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