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NCT Number: NCT04359914

Neurocognitive Impairment in Patients With COVID-19

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.

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Key information

Conditions

Critical Illness Brain Diseases COVID-19 Central Nervous System Diseases Central Nervous System Injury Confusion Coronaviridae Infections Coronavirus Infections Delirium Disease Attributes Encephalopathy Infections Lung Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Intensive Care Medicine, University Medical Center Rostock

Rostock, Mecklenburg-Vorpommern, D-18057, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Collaborators

  • Ludwig-Maximilians - University of Munich
  • University College, London

Registry information

Official study title

Biomarker-guided Assessment of Neurocognitive Impairment in Patients With COVID-19 - a Multicenter Case-control Study

Acronym: NCoV

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Apr 24, 2020
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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