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临床试验/NCT04492267
NCT04492267Unknown不适用

SARS-CoV-2 Infection in Patients From Two Tertiary Inflammatory Bowel Disease (IBD) Centres: Frequency of Suspected and Confirmed Infections, Severity and Outcome Management

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2020年7月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
700
试验地点
1
主要终点
Retrospective analysis of severity and specific needs in case of SARS-CoV-2 infection in IBD patients

研究概览

简要总结

Most of the inflammatory bowel disease (IBD: Crohn's disease and ulcerative colitis) in a tertiary expert Centre are on immunosuppressive and/or biological therapy. Theoretically, these treatments may increase patients' risk of infection, in particular viral infection. Therefore, the current SARS-Cov-2 pandemia, with its unprecedent worldwide morbidity and mortality, may have a negative impact on IBD patients' clinical course. Identifying an increased risk in this particular patients' population as well as the risk/protective factors is of outstanding importance, in order to adapt their treatment and surveillance. As a consequence, our aims were (i) to measure retrospectively the risk of SARS-CoV-2 (proven by biological testing or suspected due to record of potential clinical symptoms of COVID-19 infection) in this patients' cohort (principal objective), (ii) to identify risk or protective factors for SARS-CoV-2 infection in IBD, and (iii) to analyze the outcome of patients in case of suspected or confirmed COVID-19. The results of this study may be important to adjust our surveillance and therapeutic strategy in these patients, in particular if high virus circulation will occur in the future.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

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

  • Patient over the age of 18 years
  • IBD patients (Crohn's disease, ulcerative colitis, indeterminate colitis)
  • Patient agreeing to participate in the study

排除标准

  • Patient unable to understand the study protocol or to answer simple anamnestic questions due to language barrier
  • Patient under guardianship or trusteeship
  • Patient under safeguard of justice

结局指标

主要结局

Retrospective analysis of severity and specific needs in case of SARS-CoV-2 infection in IBD patients

时间窗: Files analysed retrospectily from March 1st, 2020 to July 31, 2020 will be examined

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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