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

1. september 2020 opdateret af: Grethe Andersen, Aarhus University Hospital

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

The purpose is to investigate the COVID-19 prevalence, associated morbidity and long-term cognitive deficits in consecutive patients presenting with acute neurological symptoms

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • DK
      • Aalborg, DK, Danmark, 9000
        • Aalborg University Hospital
      • Aarhus, DK, Danmark, 8200
        • Aarhus University Hospital
      • Holstebro, DK, Danmark, 7500
        • Regional Hospital West Jutland, Hostebro
      • Viborg, DK, Danmark, 8800
        • Regional Hospital Central Jutland, Viborg

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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
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

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

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prevalence of COVID-19 infection in consecutive patients with neurological symptoms
Tidsramme: 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)
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Three months cognitive function of COVID-19 positive patients
Tidsramme: 3 months
Three months cognitive function (Montreal Cognitive Assessment) of COVID-19 positive patients compared to COVID-19 negative patients
3 months
Clinical presentation of neurological symptoms in COVID-19 positive patients
Tidsramme: 6 months
Characterization of the neurological symptoms in neurological COVID-19 positive patients (exploratory endpoint)
6 months
Prevalence of pre- and asymptomatic COVID-19 positive patients in acutely admitted neurological patients
Tidsramme: 6 months
Prevalence of pre-symptomatic and asymptomatic COVID-19pos in acutely admitted patients with a primary complaint of neurological symptoms.
6 months
Anosmia in COVID-19 positive patients
Tidsramme: 6 months
Prevalence of anosmia in COVID-19pos patients compared to COVID-19neg patients
6 months
Exploratory analysis on neuro-specific and inflammatory blood and cerebrospinal fluid markers of COVID-19 infection
Tidsramme: 24 months
Neuro-specific and inflammatory blood- and cerebrospinal fluid markers in COVID-19 positive patients compared to COVID-19 negative matched controls
24 months
Exploratory analysis of the coagulation profile of COVID-19 positive patients compared to COVID-19neg patients
Tidsramme: 24 months
Functional and immunologic plasma assays will be employed to analyze proteins and pathways in coagulation and fibrinolysis
24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Grethe Andersen, MD, Aarhus University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

7. maj 2020

Primær færdiggørelse (Forventet)

29. november 2020

Studieafslutning (Forventet)

30. juni 2022

Datoer for studieregistrering

Først indsendt

29. april 2020

Først indsendt, der opfyldte QC-kriterier

5. maj 2020

Først opslået (Faktiske)

6. maj 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. september 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. september 2020

Sidst verificeret

1. september 2020

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

Upon reasonable request

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med COVID-19 swap test PCR

Abonner