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Neurocognitive Impairment in Patients With COVID-19 (NCoV)

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ClinicalTrials.gov Identifier: NCT04359914
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborators:
Ludwig-Maximilians - University of Munich
University College, London
Information provided by (Responsible Party):
Dr. Johannes Ehler, MD, University of Rostock

Study Description
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Brief Summary:

Delirium and acute neurocognitive impairment are increasingly observed in adult and pediatric patients with COVID-19. Prospective clinical studies combining clinical and laboratory examinations including specific biomarkers of neuroaxonal injury were not performed for COVID-19. The value of biomarkers of neuroaxonal injury was proven in preliminary studies. These biomarkers could thus contribute to the systematic detection of neurocognitive impairment in patients with COVID-19. Due to worldwide increasing numbers of hospitalized patients with COVID-19, biomarkers of neuroaxonal injury are highly valuable to detect and monitor cognitive impairment, especially with regard to limited resources available to perform time-consuming brain imaging.

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.


Condition or disease
Critical Illness COVID-19 Central Nervous System Injury Delirium Encephalopathy

Detailed Description:

This is a multicenter observational study evaluating the incidence and severity of neurocognitive impairment in adult and pediatric patients with COVID-19. All study participants will be assessed by clinical and neurological examination as well as comprehensive laboratory tests using biomarkers of neuroaxonal injury at study day 1 (day of study inclusion), day 3, day 7 and day of hospital discharge. A panel of biomarkers (among others NSE, S100B and neurofilament proteins) will be measured. Clinical assessment will be performed using validated delirium tests (among others CAM-ICU, ICDSC) and scales to assess the neurocognitive performance of study participants before and three months after study inclusion (among others Short Blessed Test).

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
Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biomarker-guided Assessment of Neurocognitive Impairment in Patients With COVID-19 - a Multicenter Case-control Study
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : April 1, 2021
Groups and Cohorts
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Group/Cohort
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
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
NCoV-P-COVID
  • pediatric patients
  • admission to hospital with suspected COVID-19 disease
  • confirmed SARS-CoV-2 infection within 48 hours after admission
NCoV-P-CONTROL
  • pediatric patient
  • admission to hospital with suspected COVID-19 disease
  • exclusion of SARS-CoV-2 infection within 48 hours after admission


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of delirium/neurocognitive impairment in adult and pediatric patients with COVID-19 compared to patients without COVID-19 [ Time Frame: Day 90 ]
    Assessment of neurocognitive impairment using validated tools

  2. Change in neuroaxonal injury biomarker levels in patients with COVID-19 compared to patients without COVID-19 [ Time Frame: Change from baseline biomarker levels at day 28 ]
    Measurement of biomarker levels (e.g. NSE, S100B, neurofilament proteins) derived from blood samples

  3. Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19 [ Time Frame: Day 90 ]
    Assessment of the neurocognitive performance of patients using validated tests (e.g. Short Blessed Test)

  4. Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19 [ Time Frame: Change from baseline IQCODE results at day 90 ]
    Assessment of the change in the neurocognitive performance of patients using validated tests (e.g. IQCODE)


Secondary Outcome Measures :
  1. Quality of life in patients with COVID-19 compared to patients without COVID-19 after hospital discharge [ Time Frame: Day 90 ]
    Assessment of the overall quality of life using validated tests [e.g. Modified Rankin Scale with a range from 0 (no symptoms) to 6 (dead)]

  2. Length of hospital stay in patients with COVID-19 compared to patients without COVID-19 [ Time Frame: 1 year ]
    Cumulative days in hospital

  3. 90-day survival in patients with COVID-19 compared to patients without COVID-19 [ Time Frame: Day 90 ]
    Survival after 90 days


Biospecimen Retention:   Samples Without DNA
Blood samples

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with suspected SARS-CoV-2 infection who are admitted to the study centers will be screened for study eligibility according to the inclusion and exclusion criteria.
Criteria

Inclusion Criteria:

  • adult patients of every age
  • admission to hospital with suspected COVID-19 disease
  • confirmed SARS-CoV-2 infection within 48 hours after admission

Exclusion Criteria:

  • transferral from another hospital
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359914


Contacts
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Contact: Johannes Ehler, MD +49381494146467 johannes.ehler@med.uni-rostock.de
Contact: Gerd Klinkmann, MD +49381494146469 Gerd.Klinkmann@med.uni-rostock.de

Locations
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Germany
Department of Anesthesiology and Intensive Care Medicine, University Medical Center Rostock Recruiting
Rostock, Mecklenburg-Vorpommern, Germany, D-18057
Contact: Johannes Ehler, MD    +49381494146467    johannes.ehler@med.uni-rostock.de   
Sponsors and Collaborators
University of Rostock
Ludwig-Maximilians - University of Munich
University College, London
Investigators
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Principal Investigator: Johannes Ehler, MD University of Rostock
More Information
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Responsible Party: Dr. Johannes Ehler, MD, PD Dr. med. Johannes Ehler, MD, University of Rostock
ClinicalTrials.gov Identifier: NCT04359914    
Other Study ID Numbers: COVID-BRAIN
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Brain Diseases
Trauma, Nervous System
Critical Illness
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Central Nervous System Diseases
Wounds and Injuries