COVID-19 Prevalence and Cognitive Deficits in Neurological Patients

NCT04377425 | Withdrawn

• 1 other identifier: Neuro-Covid-19
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 4

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

Conditions

Neurological Diseases or Conditions; Stroke, Acute; Seizure Disorder

Keywords

COVID-19; Neurological disease; Prevalence; Cognitive outcome; Stroke; Seizure/epilepsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Three months cognitive function of COVID-19 positive patients

  3 months

• Clinical presentation of neurological symptoms in COVID-19 positive patients

  6 months

• Prevalence of pre- and asymptomatic COVID-19 positive patients in acutely admitted neurological patients

  6 months

• Anosmia in COVID-19 positive patients

  6 months

• Exploratory analysis on neuro-specific and inflammatory blood and cerebrospinal fluid markers of COVID-19 infection

  24 months

Study Arms (3)

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

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

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

Interventions

COVID-19 swap test PCR DIAGNOSTIC_TEST

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

Patients with acute neurological symptoms; Seizure/epilepsy; Stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Adult patients
• New onset of neurological symptoms
• Independent in daily activities (modified Rankin Scale ≤ 2)
• Stroke or epilepsy/seizure

You may not qualify if:

• Pre-existing neurodegenerative disease
• Diagnosed with cerebral neoplasm
• Pre-existing expected life expectancy \< 3 months
• Suspected non-organic (functional) disorder

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (4)

Aalborg University Hospital

Aalborg, DK, 9000, Denmark

Location

Aarhus University Hospital

Aarhus, DK, 8200, Denmark

Location

Regional Hospital West Jutland, Hostebro

Holstebro, DK, 7500, Denmark

Location

Regional Hospital Central Jutland, Viborg

Viborg, DK, 8800, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

For study participants in the extended study: Blood samples (13mL) and cerebrospinal fluid (7mL) will be collected at baseline

MeSH Terms

Conditions

Stroke; Epilepsy; COVID-19; Nervous System Diseases; Seizures

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Grethe Andersen, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, DMSc, senior consultant

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 6, 2020
• Study Start: May 7, 2020
• Primary Completion: November 29, 2020
• Study Completion: June 30, 2022
• Last Updated: September 3, 2020

Record last verified: 2020-09

Locations

DK (4)