跳至主要内容
临床试验/NCT04418609
NCT04418609已完成不适用

Neuro-COVID-19: Neurological Complications of COVID-19

Emanuela Keller1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
1
主要终点
Prevalence of neurological complications

研究概览

简要总结

The prevalence and typical patterns of neurological complications in hospitalized COVID-19 patients admitted to the intensive care units of the University Hospital Zurich will be investigated. The impact of neurological complications among COVID-19 patients on mortality, functional outcome, and organizational outcomes will be analyzed.

详细描述

This study is a prospective observational cohort study to document prevalence and severity of neurological symptoms among patients requiring critical care admission for confirmed novel coronavirus disease (COVID-19). COVID-19 is classified as severe acute respiratory syndrome 2 (SARS-CoV-2) and shares significant structural and biological similarities with SARS-CoV, which has neuroinvasive properties and brainstem involvement. Early reports of COVID-19 progression indicate presence of severe neurological complications, including seizures, coma, encephalitis, and cerebrovascular events including ischemic stroke, intracranial hemorrhage, and cerebral venous sinus thromboses. In addition, recent data from Zika-virus and H1N1 influenza pandemics reveal a high incidence of neurological complications, including Guillain Barré syndrome and neonatal microcephaly for Zika-virus and narcolepsy with H1N1 infections. Early reports from China suggest neurological symptoms may occur in approximately 36% of SARS-CoV-2 positive patients, with increased prevalence among more severe cases, and fall into three categories: central nervous system symptoms or diseases, peripheral nervous system symptoms, and skeletal muscular symptoms. However, the exact prevalence of these conditions and impact on patient disease severity and outcomes is unknown. As the incidence and severity of COVID-19 infection continues to rapidly rise on an international level, it is imperative to capture prospective data to accurately document prevalence, severity and clinical characterization of neurological components of COVID-19, the influence of treatment regimens of neurological complications, and role of these confounders on patient and organizational outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

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

  • Adults (age > 18 years old) treated at ICUs
  • Admitted with confirmed COVID-19 infection
  • Patient exhibiting acute neurological manifestations
  • General consent of the Institute of Intensive Care Medicine available from patient or legal representative

排除标准

  • Pre-existing severe neurologic dysfunction

结局指标

主要结局

Prevalence of neurological complications

时间窗: through study completion, on an average of 3 weeks

Determine the prevalence of neurological complications in hospitalized COVID-19 patients admitted to the intensive care unit.

Prevalence and outcome of severe neurological complications

时间窗: through study completion, on an average of 3 weeks

Examine if empiric COVID-19 therapies are associated with difference in the prevalence and outcome of severe neurological complications of COVID-19.

Impact of neurological complications

时间窗: through study completion, on an average of 3 weeks

Determine the impact of neurological complications among COVID-19 patients on mortality, functional outcome, and organizational outcomes (ICU length of stay, hospital length of stay) among patients with confirmed COVID-19.

Characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF)

时间窗: through study completion, on an average of 3 weeks

Analyze characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF) of patients, in whom a lumbar puncture has been performed for clinical reasons

Brain for pathological changes and histopathological findings (if patient dies).

时间窗: through study completion, on an average of 3 weeks

Analyze the brain for pathological changes and histopathological findings, if the patient dies.

次要结局

未报告次要终点

研究者

发起方
Emanuela Keller
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emanuela Keller

Prof. Dr. Emanuela Keller

University of Zurich

研究点 (1)

Loading locations...

相似试验