Skip to main content
Clinical Trials/NCT04377425
NCT04377425
Withdrawn
Not Applicable

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

Aarhus University Hospital4 sites in 1 countryMay 7, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurological Diseases or Conditions
Sponsor
Aarhus University Hospital
Locations
4
Primary Endpoint
Prevalence of COVID-19 infection in consecutive patients with neurological symptoms
Status
Withdrawn
Last Updated
5 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 7, 2020
End Date
June 30, 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Aarhus University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Grethe Andersen

Professor, DMSc, senior consultant

Aarhus University Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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)

Secondary Outcomes

  • 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)

Study Sites (4)

Loading locations...

Similar Trials