跳至主要内容
临床试验/NCT04775784
NCT04775784招募中不适用

Determination of SARS-Cov-2 Virus in Central Nervous System

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年12月17日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pietro Mortini, MD, Prof.

Professor

IRCCS San Raffaele

研究点 (1)

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