Neurocognitive Impairment in Patients With COVID-19

NCT ID: NCT04359914

Last Updated: 2024-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-15

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness COVID-19 Central Nervous System Injury Delirium Encephalopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role collaborator

University of Rostock

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Johannes Ehler, MD

PD Dr. med. Johannes Ehler, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Johannes Ehler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rostock

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Rostock, Mecklenburg-Vorpommern, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39352661 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COVID-BRAIN

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Brain Injury and Cognitive Function
NCT05922748 RECRUITING NA