Biomarker-guided Assessment of Neurocognitive Impairment in Patients With COVID-19 - a Multicenter Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change in neuroaxonal injury biomarker levels in patients with COVID-19 compared to patients without COVID-19
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients of every age
- •admission to hospital with suspected COVID-19 disease
- •confirmed SARS-CoV-2 infection within 48 hours after admission
排除标准
- •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
结局指标
主要结局
Change in neuroaxonal injury biomarker levels in patients with COVID-19 compared to patients without COVID-19
时间窗: Change from baseline biomarker levels at day 28
Measurement of biomarker levels (e.g. NSE, S100B, neurofilament proteins) derived from blood samples
Incidence of delirium/neurocognitive impairment in adult and pediatric patients with COVID-19 compared to patients without COVID-19
时间窗: Day 90
Assessment of neurocognitive impairment using validated tools
Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19
时间窗: Change from baseline IQCODE results at day 90
Assessment of the change in the neurocognitive performance of patients using validated tests (e.g. IQCODE)
次要结局
- 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)
- Quality of life in patients with COVID-19 compared to patients without COVID-19 after hospital discharge(Day 90)
研究者
Dr. Johannes Ehler, MD
PD Dr. med. Johannes Ehler, MD
University of Rostock