Neurocognitive Impairment in Patients With COVID-19

NCT04359914 | Completed

• 1 other identifier: COVID-BRAIN
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; COVID-19; Central Nervous System Injury; Delirium; Encephalopathy

Outcome Measures

Primary Outcomes (4)

• Incidence of delirium/neurocognitive impairment in adult and pediatric patients with COVID-19 compared to patients without COVID-19

  Assessment of neurocognitive impairment using validated tools

  Day 90

• Change in neuroaxonal injury biomarker levels in patients with COVID-19 compared to patients without COVID-19

  Measurement of biomarker levels (e.g. NSE, S100B, neurofilament proteins) derived from blood samples

  Change from baseline biomarker levels at day 28

• Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19

  Assessment of the neurocognitive performance of patients using validated tests (e.g. Short Blessed Test)

  Day 90

• Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19

  Assessment of the change in the neurocognitive performance of patients using validated tests (e.g. IQCODE)

  Change from baseline IQCODE results at day 90

Secondary Outcomes (3)

• Quality of life in patients with COVID-19 compared to patients without COVID-19 after hospital discharge

  Day 90

• Length of hospital stay in patients with COVID-19 compared to patients without COVID-19

  1 year

• 90-day survival in patients with COVID-19 compared to patients without COVID-19

  Day 90

Study Arms (4)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rostock: lead
• Ludwig-Maximilians - University of Munich: collaborator
• University College, London: collaborator

Study Sites (1)

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

Rostock, Mecklenburg-Vorpommern, D-18057, Germany

Location

Related Publications (1)

• 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.

  PMID: 39352661 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Critical Illness; COVID-19; Delirium; Brain Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Central Nervous System Diseases

Study Officials

• Johannes Ehler, MD

  University of Rostock

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Johannes Ehler, MD

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 24, 2020
• Study Start: April 15, 2020
• Primary Completion: March 31, 2021
• Study Completion: December 31, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)