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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04377425
Other study ID # Neuro-Covid-19
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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