Determination of SARS-Cov-2 Virus in Central Nervous System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Determination of SARS-CoV-2 presence in the CNS
研究概览
简要总结
Coronavirus disease 2019 (COVID-19) is a highly infectious pandemic disease caused by SARS-CoV-2 virus. Central Nervous System (CNS) complications associated with COVID-19 might be secondary sequelae due to exuberant systemic innate-mediated hyper-inflammation, which may impair neurovascular endothelial function, disrupt blood brain barrier (BBB), activates CNS innate immune signaling pathways, and induces parainfectious autoimmunity, potentially contributing to the CNS manifestations. Although the predominant clinical manifestation of SARS-CoV-2 is characterized by dyspnea, unremitting fever and hypoxemic respiratory failure, neurologic manifestations do occur in most hospitalized SARS-CoV-2 patients and include non-specific encephalopathy, psychosis, meningitis/encephalitis, myelitis, cerebrovascular events, Guillain-Barre' syndrome, and cranial or peripheral neuropathies, such as anosmia and ageusia. To date, data about primary CNS involvement due to neurotropism and direct neuroinvasion are still lacking.
详细描述
Determination of SARS-CoV-2 presence in central nervous system
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
- •Patients candidate for CNS surgery
- •Patients who have been tested for nasopharyngeal swab for SARS-CoV-2
- •Patients who have been tested for serology test for anti SARS-CoV-2 immunoglobulinG (IgG) and immunoglobulinM (IgM) antibodies
- •Patients able to sign informed consent
排除标准
- •Patients not meeting inclusion criteria
结局指标
主要结局
Determination of SARS-CoV-2 presence in the CNS
时间窗: Surgery
Brain tissue sampling analysis
次要结局
未报告次要终点
研究者
Pietro Mortini, MD, Prof.
Professor
IRCCS San Raffaele
