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| Name | Class |
|---|---|
| Ludwig-Maximilians - University of Munich | OTHER |
| University College, London | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCoV-A-COVID |
| ||
| NCoV-A-CONTROL |
| ||
| NCoV-P-COVID |
| ||
| NCoV-P-CONTROL |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life in patients with COVID-19 compared to patients without COVID-19 after hospital discharge | 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)] | Day 90 |
| Length of hospital stay in patients with COVID-19 compared to patients without COVID-19 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Ehler, MD | University of Rostock | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Intensive Care Medicine, University Medical Center Rostock | Rostock | Mecklenburg-Vorpommern | D-18057 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39352661 | Derived | 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. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D000086382 | COVID-19 |
| D003693 | Delirium |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
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Blood samples
Cumulative days in hospital |
| 1 year |
| 90-day survival in patients with COVID-19 compared to patients without COVID-19 | Survival after 90 days | Day 90 |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002493 | Central Nervous System Diseases |