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临床试验/NCT04472013
NCT04472013已完成不适用

Systematic Assessment of SARS-CoV-2 Neurotropic Capacity in Modestly and Critically Ill Patients, and Patients Who Died From COVID-19

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Proteomic analysis

研究概览

简要总结

This study is to analyze the microglia reaction or direct neurotropic effects of CNS COVID-19 in pathogenesis and brain stem dysfunction in critically ill patients. A microglia-focused, brain-specific 50+ marker CODEX panel is used to assess the neuroinflammatory microenvironment in specific brain regions of deceased COVID-19 patients. The peripheral (cerebrospinal fluid and peripheral blood) cytokine response to SARS-CoV-2 is investigated in regard to CNS affection and consecutive blood brain barrier disruption leading to braininherent neuroinflammatory reactions

详细描述

This study is to analyze the microglia reaction or direct neurotropic effects of CNS COVID-19 in pathogenesis and brain stem dysfunction in critically ill patients. A microglia-focused, brain-specific 50+ marker CODEX panel is used to assess the neuroinflammatory microenvironment in specific brain regions of deceased COVID-19 patients. The peripheral (cerebrospinal fluid and peripheral blood) cytokine response to SARS-CoV-2 is investigated in regard to CNS affection and consecutive blood brain barrier disruption leading to braininherent neuroinflammatory reactions. Primary endpoints of this project are the multidimensional integration of the analysis from the procedures described above and assessment of the correlation between the gained clinical data (MRI, mental/neurological state), the body fluid proteomic and mass-cytometric analysis (CSF and Plasma proteomics, peripheral blood mass cytometry) and the CODEX analysis of defined brain regions on autopsy specimens.

Non-critically ill COVID-19 patients and critically ill COVID-19 patients needing mechanical ventilation at the ICU are included. Autopsy specimens from medulla oblongata, cortex, cerebellum and olfactory bulb are investigated, including only tissue samples, which have been submitted to the Institute of Pathology, University Hospital Basel.

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

  • COVID-19 positive tested

排除标准

  • COVID-19 negative tested
  • pregnant women

结局指标

主要结局

Proteomic analysis

时间窗: 10 minutes for blood draw at baseline

Description of proteomic biomarkers (CSF and Plasma) in comparison with control reference sample.

CODEX (high dimensional microscopy) workflow analysis of defined regions on brain autopsy specimens

时间窗: at baseline

In situ distribution assessment of marker expression (CD147 protein, ACE2 protein, Transmembrane protease serine subtype 2 (TMPRSS2))

Peripheral blood leukocyte Cytof Mass Cytometry Analysis for cell population frequency

时间窗: 10 minutes for blood draw at baseline

Mass cytometry will be performed form peripheral blood mononuclear cells to count cell population frequency.

MRI imaging data

时间窗: Project duration for each patient takes 1 hour for the MRI at baseline

Comparison of lesions from patients that are neurologically affected to non-affected individuals in terms of CNS involvement to describe encephalitic changes due to COVID-19 infection.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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