COVID-19 Clinical Trial
— NCoVOfficial title:
Biomarker-guided Assessment of Neurocognitive Impairment in Patients With COVID-19 - a Multicenter Case-control Study
Verified date | January 2024 |
Source | University of Rostock |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 118 |
Est. completion date | December 31, 2023 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Anesthesiology and Intensive Care Medicine, University Medical Center Rostock | Rostock | Mecklenburg-Vorpommern |
Lead Sponsor | Collaborator |
---|---|
University of Rostock | Ludwig-Maximilians - University of Munich, University College, London |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Length of hospital stay in patients with COVID-19 compared to patients without COVID-19 | Cumulative days in hospital | 1 year | |
Secondary | 90-day survival in patients with COVID-19 compared to patients without COVID-19 | Survival after 90 days | Day 90 |
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