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Clinical Trials/NCT04578197
NCT04578197
Unknown
Not Applicable

NeuroCOVID - A Study of Activation and Inhibition of the Immune and Coagulation Systems, the Presence of Biochemical (Blood / CSF) and Structural Brain Changes and Their Association With Long-term Cognitive Dysfunction in Intensive Care-requiring Covid-19 Patients

Karolinska University Hospital1 site in 1 country100 target enrollmentAugust 18, 2020
ConditionsCovid19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Karolinska University Hospital
Enrollment
100
Locations
1
Primary Endpoint
The association between changes in blood biomarkers for neurodegeneration and the presence of neuroradiologically verified brain injury and neurocognitive disorder
Last Updated
5 years ago

Overview

Brief Summary

Critically ill patients requiring intensive care suffer to a large extent from cognitive deficits involving higher brain functions that primarily affect memory, learning and the ability to concentrate. While the background to this effect is not fully understood, there are growing evidence to support mechanisms related to neuro inflammation and changes in blood flow with concomitant ischemic brain damage. Patients with covid-19 often suffer from severe inflammatory activity with an increased risk of coagulation abnormalities and brain damage. Covid-19 patients requiring intensive care develope more severe impairment of neurological and cognitive function than critically ill intensive care patients who have not covid-19. This project therefore aims to map the link between inflammation, immunology and coagulation systems as well as biochemical and structural changes in the brain with cognitive effects in patients in intensive care for covid-19.

Registry
clinicaltrials.gov
Start Date
August 18, 2020
End Date
November 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Karolinska University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Lars I Eriksson

Professor

Karolinska University Hospital

Eligibility Criteria

Inclusion Criteria

  • Age ≥18 years
  • Need for Intensive care
  • Positive PCR test for SARS-CoV-2

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The association between changes in blood biomarkers for neurodegeneration and the presence of neuroradiologically verified brain injury and neurocognitive disorder

Time Frame: Up to 12 months

The association between changes in blood biomarkers for inflammation and the presence of neuroradiologically verified brain injury and neurocognitive disorder

Time Frame: Up to 12 months

The association between changes in blood biomarkers for nerve cell damage and the presence of neuroradiologically verified brain injury and neurocognitive disorder

Time Frame: Up to 12 months

Secondary Outcomes

  • Blood biomarker changes of neurological impact(Up to 3 months)
  • Clinical course - Pulmonary gas exchange(Up to 3 months)
  • Clinical course - Lung function recording(Up to 3 months)
  • The association between changes in coagulation factors and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder(Up to 12 months)
  • The association between changes in coagulation ability (ROTEM analysis - rotational thromboelastometry) and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder(Up to 12 months)
  • The association between changes in inflammatory biomarkers and the presence of neuroradiologically verified brain injury and / or neurocognitive disorder(Up to 12 month)
  • Blood biomarker changes of inflammation impact(Up to 3 months)
  • Neuroradiological changes(Up to 3 months)
  • Patient characteristics(Up to 3 months)

Study Sites (1)

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