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临床试验/NCT04405726
NCT04405726Unknown不适用

Study of Clinical, Biological and Genetic Prognostic Factors of SARS-CoV-2 Infection in Patients Admitted in the Strasbourg University Hospitals

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年3月27日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Clinical Presentation and Incidence of Covid-19 Infection in patients hospitalised in Strasbourg Hospital

研究概览

简要总结

COVID-19 is an emerging disease, for which no specific treatment options are currently available. Since the end of February 2020, and due to a SARS-CoV-2 superspreading event (religious meeting), the Strasbourg University Hospital (HUS) had faced a sudden increase of the number of COVID-19-positive patients in serious condition requiring hospitalization. At the same time, many people develop only mild or moderate symptoms. To date, the prognostic factors for the course of SARS-CoV-2 infection are unknown. The primary purpose of the "COVID-HUS" protocol is to investigate viral and host-related factors to understand the pathophysiology of COVID infection and to open the way for new diagnostic, prognostic and therapeutic strategies against SARS CoV-2 .

The secondary objectives are

  • Monitoring of viral replication of SARS-CoV-2 in the blood and respiratory tract in infected patients
  • Monitoring of the humoral and cellular response directed against SARS-CoV-2
  • Identification of factors leading to significant and / or prolonged viral replication of SARS-CoV-2 in the blood or respiratory samples
  • Evaluation of the benefit of possible treatments implemented following the diagnosis of SARS-CoV-2 infection
  • Exploration of the B and T immune repertoire sequences targeting SARS-CoV-2 in infected patients
  • Typing of the HLA system in infected patients

研究设计

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

入排标准

年龄范围
1 Year 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult and pediatric with suspicion or a confirmed SARS-CoV-2 infection
  • Patient who has signed a non-opposition form (or a form signed by a family member or a support person if the seriousness of the patient's condition and the emergency situation do not allow it) or who has given his oral agreement to the doctor

排除标准

  • Patient's explicit refusal to participate
  • Subject deprived of liberty or subject to the protection of justice
  • Subject under guardianship or trusteeship

结局指标

主要结局

Clinical Presentation and Incidence of Covid-19 Infection in patients hospitalised in Strasbourg Hospital

时间窗: From 1st March 2020 to 1st March 2021

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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