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Clinical Trials/NCT04472013
NCT04472013
Completed
Not Applicable

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 site in 1 country40 target enrollmentAugust 12, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19 Disease
Sponsor
University Hospital, Basel, Switzerland
Enrollment
40
Locations
1
Primary Endpoint
Proteomic analysis
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 12, 2020
End Date
November 9, 2022
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • COVID-19 positive tested

Exclusion Criteria

  • COVID-19 negative tested
  • pregnant women

Outcomes

Primary Outcomes

Proteomic analysis

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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