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COVID-19 Prevalence and Cognitive Deficits in Neurological Patients (Neuro-Covid)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377425
Recruitment Status : Withdrawn (No acute neurological patients presented with concomitant COVID-19)
First Posted : May 6, 2020
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Grethe Andersen, 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

Condition or disease Intervention/treatment
Neurological Diseases or Conditions Stroke, Acute Seizure Disorder Diagnostic Test: COVID-19 swap test PCR

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 Prevalence, Morbidity and Long Term Cognitive Deficits in Consecutive Patients Presenting With Acute Neurological Symptoms
Estimated Study Start Date : May 7, 2020
Estimated Primary Completion Date : November 29, 2020
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with acute neurological symptoms
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
Diagnostic Test: COVID-19 swap test PCR
COVID-19 swap test PCR performed according to hospital standard operating procedures

Stroke patients

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

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

Seizure/epilepsy

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

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Three months cognitive function of COVID-19 positive patients [ Time Frame: 3 months ]
    Three months cognitive function (Montreal Cognitive Assessment) of COVID-19 positive patients compared to COVID-19 negative patients

  2. Clinical presentation of neurological symptoms in COVID-19 positive patients [ Time Frame: 6 months ]
    Characterization of the neurological symptoms in neurological COVID-19 positive patients (exploratory endpoint)

  3. Prevalence of pre- and asymptomatic COVID-19 positive patients in acutely admitted neurological patients [ Time Frame: 6 months ]
    Prevalence of pre-symptomatic and asymptomatic COVID-19pos in acutely admitted patients with a primary complaint of neurological symptoms.

  4. Anosmia in COVID-19 positive patients [ Time Frame: 6 months ]
    Prevalence of anosmia in COVID-19pos patients compared to COVID-19neg patients

  5. Exploratory analysis on neuro-specific and inflammatory blood and cerebrospinal fluid markers of COVID-19 infection [ Time Frame: 24 months ]
    Neuro-specific and inflammatory blood- and cerebrospinal fluid markers in COVID-19 positive patients compared to COVID-19 negative matched controls

  6. Exploratory analysis of the coagulation profile of COVID-19 positive patients compared to COVID-19neg patients [ Time Frame: 24 months ]
    Functional and immunologic plasma assays will be employed to analyze proteins and pathways in coagulation and fibrinolysis


Biospecimen Retention:   Samples Without DNA

For study participants in the extended study:

Blood samples (13mL) and cerebrospinal fluid (7mL) will be collected at baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377425


Locations
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Denmark
Aalborg University Hospital
Aalborg, DK, Denmark, 9000
Aarhus University Hospital
Aarhus, DK, Denmark, 8200
Regional Hospital West Jutland, Hostebro
Holstebro, DK, Denmark, 7500
Regional Hospital Central Jutland, Viborg
Viborg, DK, Denmark, 8800
Sponsors and Collaborators
Aarhus University Hospital
Investigators
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Principal Investigator: Grethe Andersen, MD Aarhus University Hospital
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Responsible Party: Grethe Andersen, Professor, DMSc, senior consultant, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT04377425    
Other Study ID Numbers: Neuro-Covid-19
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Upon reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Grethe Andersen, Aarhus University Hospital:
COVID-19
Neurological disease
Prevalence
Cognitive outcome
Stroke
Seizure/epilepsy
Additional relevant MeSH terms:
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Stroke
Seizures
Nervous System Diseases
Epilepsy
Cognition Disorders
Cognitive Dysfunction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Neurocognitive Disorders
Mental Disorders