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临床试验/NCT04515225
NCT04515225Unknown不适用

Seroprevalence of SARS-CoV-2 Antibodies Among Adult Patients Living With HIV

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11月4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
Seroprevalence of SARS-CoV-2

研究概览

简要总结

North-east area of France was hit in February 2020 by the new coronavirus disease, more severely than other French regions. Factors affecting the evolution of the disease and its severity have been quickly identified, among them figuring different kinds of immune deficiency. Even if nowadays HIV infection is usually well controlled by ARV drugs, those patients with uncontrolled viral load and/or low CD4 cell counts, remain at higher risk of severe COVID infection. In this context, the primary objective of our study is aimed at evaluating the prevalence of SARS-CoV-2 antibodies in a cohort of HIV-infected patients followed-up in an HIV-infection care center. Secondary objectives are: evaluating whether the antibodies are protective or not, the kinetic of these antibodies, and HIV associated factors with the presence of antibodies.

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 (> 18 years)
  • HIV-infected patients
  • subjects with social insurance
  • subjects able to understand study purposes, and to give a written and informed consent
  • Exclusion Criteria :
  • subjects unable to understand informations on the study, and to provide informed consent
  • subjects under guardianship or curatorship
  • subjects under judicial protection

排除标准

  • 未提供

结局指标

主要结局

Seroprevalence of SARS-CoV-2

时间窗: From baseline to 12 months

SARS-CoV-2 antibodies will be detected with a rapid test detecting IgG and IgM, at inclusion, and during a 6-month and a 12-month visit, in order to assess the prevalence of the virus in this population.

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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