Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
118 participants
OBSERVATIONAL
2020-04-15
2023-12-31
Brief Summary
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Biomarkers of neuroaxonal injury are therefore not only of great interest to detect neurocognitive impairment but also to quantify the severity of brain injury in patients with COVID-19.
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Detailed Description
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A group of patients with a comparable severity of disease but without the detection of SARS-Cov-2 will serve as control group and will undergo the same clinical and laboratory examinations.
We hypothesize, that:
* patients with COVID-19 are more likely to develop delirium and neurocognitive impairment than patients without COVID-19
* patients with a preexisting neurocognitive deficit are more vulnerable to neurocognitive impairment in the course of COVID-19 than patients without a preexisting neurocognitive deficit
* Specific biomarkers of neuroaxonal injury correlate with the clinical severity of acute neurocognitive impairment and can predict the 3-month neurocognitive outcome of patients with COVID-19
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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NCoV-A-COVID
* adult patients of every age
* admission to hospital with suspected COVID-19 disease
* confirmed SARS-CoV-2 infection within 48 hours after admission
No interventions assigned to this group
NCoV-A-CONTROL
* adult patients of every age
* admission to hospital with suspected COVID-19 disease
* exclusion of SARS-CoV-2 infection within 48 hours after admission
No interventions assigned to this group
NCoV-P-COVID
* pediatric patients
* admission to hospital with suspected COVID-19 disease
* confirmed SARS-CoV-2 infection within 48 hours after admission
No interventions assigned to this group
NCoV-P-CONTROL
* pediatric patient
* admission to hospital with suspected COVID-19 disease
* exclusion of SARS-CoV-2 infection within 48 hours after admission
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* admission to hospital with suspected COVID-19 disease
* confirmed SARS-CoV-2 infection within 48 hours after admission
Exclusion Criteria
* other acute central nervous system diseases (e.g. meningoencephalitis, intracerebral ischemia or hemorrhage)
* confirmed SARS-CoV-2 infection later than 48 hours after hospital admission
* participation in another interventional study
* no written informed consent from patient or legal representative
ALL
No
Sponsors
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Ludwig-Maximilians - University of Munich
OTHER
University College, London
OTHER
University of Rostock
OTHER
Responsible Party
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Dr. Johannes Ehler, MD
PD Dr. med. Johannes Ehler, MD
Principal Investigators
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Johannes Ehler, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rostock
Locations
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Department of Anesthesiology and Intensive Care Medicine, University Medical Center Rostock
Rostock, Mecklenburg-Vorpommern, Germany
Countries
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References
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Ehler J, Klawitter F, von Mollendorff F, Zacharias M, Fischer DC, Danckert L, Bajorat R, Hackenberg J, Bertsche A, Loebermann M, Geerdes-Fenge H, Fleischmann R, Klinkmann G, Schramm P, Schober S, Petzold A, Perneczky R, Saller T. No substantial neurocognitive impact of COVID-19 across ages and disease severity: a multicenter biomarker study of SARS-CoV-2 positive and negative adult and pediatric patients with acute respiratory tract infections. Infection. 2025 Apr;53(2):593-605. doi: 10.1007/s15010-024-02406-7. Epub 2024 Oct 1.
Other Identifiers
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COVID-BRAIN
Identifier Type: -
Identifier Source: org_study_id
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