COVID-19 Prevalence and Cognitive Deficits in Neurological Patients
- Conditions
- Stroke, AcuteNeurological Diseases or ConditionsSeizure Disorder
- Interventions
- Diagnostic Test: COVID-19 swap test PCR
- Registration Number
- NCT04377425
- Lead Sponsor
- Aarhus University Hospital
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Adult patients
- New onset of neurological symptoms
- Independent in daily activities (modified Rankin Scale ≤ 2)
- Stroke or epilepsy/seizure
- Pre-existing neurodegenerative disease
- Diagnosed with cerebral neoplasm
- Pre-existing expected life expectancy < 3 months
- Suspected non-organic (functional) disorder
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Seizure/epilepsy COVID-19 swap test PCR COVID-19 positive patients will be asked to participate in the extended study together with matched COVID-19 negative controls. Extended study: Collection of cerebrospinal fluid and blood-samples, clinical and cognitive assessment at baseline and at 3-month follow-up Stroke patients COVID-19 swap test PCR COVID-19 positive patients will be asked to participate in the extended study together with matched COVID-19 negative controls. Extended study: Collection of cerebrospinal fluid and blood-samples, clinical and cognitive assessment at baseline and at 3-month follow-up Patients with acute neurological symptoms COVID-19 swap test PCR Consecutive patients with acute neurological disease admitted at the Neurology departments will be tested with a nasopharyngeal swap for SARS-COVID-19 RNA according to standard operating procedures at the department (if estimated hospital stay is \>24hours). Medical and clinical characteristics will be collected
- Primary Outcome Measures
Name Time Method Prevalence of COVID-19 infection in consecutive patients with neurological symptoms 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 Outcome Measures
Name Time Method Three months cognitive function of COVID-19 positive patients 3 months Three months cognitive function (Montreal Cognitive Assessment) of COVID-19 positive patients compared to COVID-19 negative patients
Clinical presentation of neurological symptoms in COVID-19 positive patients 6 months Characterization of the neurological symptoms in neurological COVID-19 positive patients (exploratory endpoint)
Prevalence of pre- and asymptomatic COVID-19 positive patients in acutely admitted neurological patients 6 months Prevalence of pre-symptomatic and asymptomatic COVID-19pos in acutely admitted patients with a primary complaint of neurological symptoms.
Anosmia in COVID-19 positive patients 6 months Prevalence of anosmia in COVID-19pos patients compared to COVID-19neg patients
Exploratory analysis on neuro-specific and inflammatory blood and cerebrospinal fluid markers of COVID-19 infection 24 months Neuro-specific and inflammatory blood- and cerebrospinal fluid markers in COVID-19 positive patients compared to COVID-19 negative matched controls
Exploratory analysis of the coagulation profile of COVID-19 positive patients compared to COVID-19neg patients 24 months Functional and immunologic plasma assays will be employed to analyze proteins and pathways in coagulation and fibrinolysis
Trial Locations
- Locations (4)
Aalborg University Hospital
🇩🇰Aalborg, DK, Denmark
Regional Hospital West Jutland, Hostebro
🇩🇰Holstebro, DK, Denmark
Aarhus University Hospital
🇩🇰Aarhus, DK, Denmark
Regional Hospital Central Jutland, Viborg
🇩🇰Viborg, DK, Denmark