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临床试验/NCT04377425
NCT04377425撤回不适用

COVID-19 Prevalence, Morbidity and Long Term Cognitive Deficits in Consecutive Patients Presenting With Acute Neurological Symptoms

Aarhus University Hospital4 个研究点 分布在 1 个国家开始时间: 2020年5月7日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
4
主要终点
Prevalence of COVID-19 infection in consecutive patients with neurological symptoms

研究概览

简要总结

The purpose is to investigate the COVID-19 prevalence, associated morbidity and long-term cognitive deficits in consecutive patients presenting with acute neurological symptoms

详细描述

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is spreading in nearly every country in the world. Patients with coronavirus disease 2019 (COVID-19) typically present with cough, fever and respiratory illness. In another coronavirus (SARS-COV-1) causing the SARS outbreak in 2002 to 2003, neurons have been found to be highly susceptible for infection and the virus can cause extensive neuronal damage with only minimal respiratory affection. Similar to SARS-CoV-1, COVID-19 virus exploits the angiotensin-converting enzyme 2 (ACE-2) receptor to gain entry and infect cells. Both glial and neurons express ACE-2 receptors and makes them potential targets, however the neurotropic potential in humans remain largely undescribed. Neurological manifestations of COVID-19 have only been sporadically described in single or short series of case reports together with a case of COVID-19 RNA in the cerebrospinal fluid.

Loss of smell (anosmia) may be a presenting symptom in COVID-19. Interestingly, in a study from Italy anosmia was present in 19,4% and not typical accompanied by nasal obstruction, rhinitis or sinusitis, making direct damage and invasion of the olfactory nerve more likely. A Chinese study have found that 36.6% of COVID-19 patients experience neurological symptoms and that severely affected COVID-19 patients reported more neurological symptoms.

In general, neurological manifestations to viral disease may occur as a direct result of viral invasion and damage to either the central or peripheral nervous system or from an immune mediated neurological damage either during (para) or after (post) the viral infection. Furthermore, the inflammation in itself can increase the risk of arterial thrombosis and thus ischemic stroke.

Early reports from Italy stresses the need to pay attention to neurological symptoms, as they are often neglected due to the systemic and respiratory impairment. Further, concerning reports from the Center for Disease Control (CDC) in USA, have estimated that out of COVID-19pos patients up to 46.5% may be asymptomatic/pre-symptomatic and 17,5% never develop classical COVID-19 symptoms. The COVID-19 infection is likely to be missed if patients present with symptoms from another organ system. Moreover, it poses a transmission risk for other admitted patients and healthcare workers and a risk that a possible association between e.g. neurological symptoms/diseases and a COVID-19 infection are missed. The role and presence of COVID-19 infection in patients presenting with acute neurological symptoms is currently unknown.

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
  • New onset of neurological symptoms
  • Independent in daily activities (modified Rankin Scale ≤ 2)
  • Stroke or epilepsy/seizure

排除标准

  • Pre-existing neurodegenerative disease
  • Diagnosed with cerebral neoplasm
  • Pre-existing expected life expectancy < 3 months
  • Suspected non-organic (functional) disorder

结局指标

主要结局

Prevalence of COVID-19 infection in consecutive patients with neurological symptoms

时间窗: 6 months

To investigate the prevalence of COVID-19 infections in consecutive patients with acute onset of neurological symptoms (with or without prior neurological disease)

次要结局

  • Three months cognitive function of COVID-19 positive patients(3 months)
  • Clinical presentation of neurological symptoms in COVID-19 positive patients(6 months)
  • Prevalence of pre- and asymptomatic COVID-19 positive patients in acutely admitted neurological patients(6 months)
  • Anosmia in COVID-19 positive patients(6 months)
  • Exploratory analysis on neuro-specific and inflammatory blood and cerebrospinal fluid markers of COVID-19 infection(24 months)
  • Exploratory analysis of the coagulation profile of COVID-19 positive patients compared to COVID-19neg patients(24 months)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Grethe Andersen

Professor, DMSc, senior consultant

Aarhus University Hospital

研究点 (4)

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