SARS-CoV-2 Neurotropism, micRoglial ActivatioN and Cytokine dySregulaTiOn in COVID-19 Patients With Delirium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- PET imaging examination
研究概览
简要总结
Emerging evidence indicates that SARS-CoV-2, the etiologic agent of COVID-19, can cause neurological, neuropsychological and psychiatric complications. Given the global dimensions of the current pandemic, there is to consider the possible large-scale neurocognitive impact of COVID-19. Therefore, there is an urgent need for longitudinal studies to determine the acute and chronic effects that COVID-19 may have on the Central Nervous System. These putative effects include the possibility that the CNS serves as a reservoir for the virus, and that COVID-19 triggers CNS deleterious inflammatory cascades and neurodegenerative process. The public implications of these effects are very important in the long term.
详细描述
The BRAINSTORM project aims at creating a proof-of-concept dataset from severe COVID-19 patients with delirium. For the first time, this longitudinal study will rely on repeated and concomitant: i) SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF), ii) systemic and central immune response characterization, associated to the assessment of CNS damage biomarkers (peripheral blood and CSF), iii) in vivo brain PET-TSPO acquisitions (Positon Emission Tomography using a radioligand that targets the Translocator Protein, which is upregulated in activated microglia), iv) structural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity), v) multi-domains neurocognitive assessment. This dataset will be made FAIR to allow open data use and to prepare future studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (male or female > or = 18 years)
- •COVID-19 (positive respiratory track PCR test < 30 days)
- •Delirium (CAM-ICU criteria)
- •informed and written consent to participate in the study by patient's surrogate.
排除标准
- •medical decision of withdrawal of life sustaining treatments previous to patients recruitment
- •former neurological or psychiatric disability
- •MRI or PET scan contraindication
- •pregnancy
- •hemodynamic or respiratory failure precluding patient's transport / MRI or PET scanning
结局指标
主要结局
PET imaging examination
时间窗: Month 3
Intensity and topography of \[18F\]DPA-714-labeled microglial activation in vivo in PET imaging examination
次要结局
- SARS-CoV-2 quasispecies detection in acute delirium phase in blood specimen(Day 0)
- multimodal MRI in acute delirium phase(Day 0)
- multimodal MRI 3 months after the acute delirium phase(month 3)
- SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in blood specimen(Month 3)
- SARS-CoV-2 quasispecies detection in acute delirium phase in cerebrospinal fluid specimen(Day 0)
- SARS-CoV-2 quasispecies detection 3 month after the acute delirium phase in cerebrospinal fluid specimen(Month 3)