An observational study in Critical Illness, COVID-19 and Central Nervous System Injury, sponsored by University of Rostock. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by University of Rostock · 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.
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:
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 118 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →University of Rostock is the lead sponsor of 46 studies on the registry; 3 are open to participants now.
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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.
Exclusion Criteria:
* adult patients of every age * admission to hospital with suspected COVID-19 disease * confirmed SARS-CoV-2 infection within 48 hours after admission
* adult patients of every age * admission to hospital with suspected COVID-19 disease * exclusion of SARS-CoV-2 infection within 48 hours after admission
* pediatric patients * admission to hospital with suspected COVID-19 disease * confirmed SARS-CoV-2 infection within 48 hours after admission
* pediatric patient * admission to hospital with suspected COVID-19 disease * exclusion of SARS-CoV-2 infection within 48 hours after admission
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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Change from baseline IQCODE results at day 90
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 \[e.g. Modified Rankin Scale with a range from 0 (no symptoms) to 6 (dead)\]
Time frame: Day 90
Length of hospital stay in patients with COVID-19 compared to patients without COVID-19
Cumulative days in hospital
Time frame: 1 year
90-day survival in patients with COVID-19 compared to patients without COVID-19
Survival after 90 days
Time frame: Day 90
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University of Rostock