COVID-19 Prevalence and Cognitive Deficits in Neurological Patients

Stroke, Acute Clinical Trial

— Neuro-Covid  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04377425
• Other study ID #: Neuro-Covid-19
• Status: Withdrawn
• Start date: May 7, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2020
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2022
• Est. primary completion date: November 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• Epilepsy
• Nervous System Diseases
• Neurological Diseases or Conditions
• Seizure Disorder
• Seizures
• Stroke
• Stroke, Acute

Intervention

Diagnostic Test:
• COVID-19 swap test PCR
COVID-19 swap test PCR performed according to hospital standard operating procedures

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg	DK
Denmark	Aarhus University Hospital	Aarhus	DK
Denmark	Regional Hospital West Jutland, Hostebro	Holstebro	DK
Denmark	Regional Hospital Central Jutland, Viborg	Viborg	DK

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of COVID-19 infection in consecutive patients with neurological symptoms	To investigate the prevalence of COVID-19 infections in consecutive patients with acute onset of neurological symptoms (with or without prior neurological disease)	6 months
Secondary	Three months cognitive function of COVID-19 positive patients	Three months cognitive function (Montreal Cognitive Assessment) of COVID-19 positive patients compared to COVID-19 negative patients	3 months
Secondary	Clinical presentation of neurological symptoms in COVID-19 positive patients	Characterization of the neurological symptoms in neurological COVID-19 positive patients (exploratory endpoint)	6 months
Secondary	Prevalence of pre- and asymptomatic COVID-19 positive patients in acutely admitted neurological patients	Prevalence of pre-symptomatic and asymptomatic COVID-19pos in acutely admitted patients with a primary complaint of neurological symptoms.	6 months
Secondary	Anosmia in COVID-19 positive patients	Prevalence of anosmia in COVID-19pos patients compared to COVID-19neg patients	6 months
Secondary	Exploratory analysis on neuro-specific and inflammatory blood and cerebrospinal fluid markers of COVID-19 infection	Neuro-specific and inflammatory blood- and cerebrospinal fluid markers in COVID-19 positive patients compared to COVID-19 negative matched controls	24 months
Secondary	Exploratory analysis of the coagulation profile of COVID-19 positive patients compared to COVID-19neg patients	Functional and immunologic plasma assays will be employed to analyze proteins and pathways in coagulation and fibrinolysis	24 months