Clinical trial NCT04377425: COVID-19 Prevalence and Cognitive Deficits in Neurological Patients
Official title: COVID-19 Prevalence, Morbidity and Long Term Cognitive Deficits in Consecutive Patients Presenting With Acute Neurological Symptoms
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Neurological Diseases or Conditions
Stroke, Acute
Seizure Disorder
Keywords: COVID-19
Neurological disease
Prevalence
Cognitive outcome
Stroke
Seizure/epilepsy
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Base study: Consecutive patients with acute neurological disease admitted at the Neurology department at Aarhus University Hospital will be tested with a nasopharyngeal swap for SARS-COVID-19 RNA

Extended study: Patients fulfilling the extended study criteria will be asked to participate in extended study depending on their COVID-19 status and whether study criteria are fulfilled

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.

Eligibility criteria: Eligibility criteria for the extended study:

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

Primary outcomes:
measure: Prevalence of COVID-19 infection in consecutive patients with neurological symptoms
timeFrame: 6 months
Secondary outcomes:
measure: Three months cognitive function of COVID-19 positive patients
timeFrame: 3 months
measure: Clinical presentation of neurological symptoms in COVID-19 positive patients
timeFrame: 6 months
measure: Prevalence of pre- and asymptomatic COVID-19 positive patients in acutely admitted neurological patients
timeFrame: 6 months
measure: Anosmia in COVID-19 positive patients
timeFrame: 6 months
measure: Exploratory analysis on neuro-specific and inflammatory blood and cerebrospinal fluid markers of COVID-19 infection
timeFrame: 24 months
measure: Exploratory analysis of the coagulation profile of COVID-19 positive patients compared to COVID-19neg patients
timeFrame: 24 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: DK
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: DK
city: Holstebro
country: Denmark
facility: Regional Hospital West Jutland, Hostebro
state: DK
city: Viborg
country: Denmark
facility: Regional Hospital Central Jutland, Viborg
state: DK
Study officials:
affiliation: Aarhus University Hospital
name: Grethe Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References: