- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04377425
COVID-19 Prevalence and Cognitive Deficits in Neurological Patients (Neuro-Covid)
COVID-19 Prevalence, Morbidity and Long Term Cognitive Deficits in Consecutive Patients Presenting With Acute Neurological Symptoms
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Kontakter og plasseringer
Studiesteder
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DK
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Aalborg, DK, Danmark, 9000
- Aalborg University Hospital
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Aarhus, DK, Danmark, 8200
- Aarhus University Hospital
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Holstebro, DK, Danmark, 7500
- Regional Hospital West Jutland, Hostebro
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Viborg, DK, Danmark, 8800
- Regional Hospital Central Jutland, Viborg
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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
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COVID-19 swap test PCR performed according to hospital standard operating procedures
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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
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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
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Prevalence of COVID-19 infection in consecutive patients with neurological symptoms
Tidsramme: 6 months
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To investigate the prevalence of COVID-19 infections in consecutive patients with acute onset of neurological symptoms (with or without prior neurological disease)
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6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Three months cognitive function of COVID-19 positive patients
Tidsramme: 3 months
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Three months cognitive function (Montreal Cognitive Assessment) of COVID-19 positive patients compared to COVID-19 negative patients
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3 months
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Clinical presentation of neurological symptoms in COVID-19 positive patients
Tidsramme: 6 months
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Characterization of the neurological symptoms in neurological COVID-19 positive patients (exploratory endpoint)
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6 months
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Prevalence of pre- and asymptomatic COVID-19 positive patients in acutely admitted neurological patients
Tidsramme: 6 months
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Prevalence of pre-symptomatic and asymptomatic COVID-19pos in acutely admitted patients with a primary complaint of neurological symptoms.
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6 months
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Anosmia in COVID-19 positive patients
Tidsramme: 6 months
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Prevalence of anosmia in COVID-19pos patients compared to COVID-19neg patients
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6 months
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Exploratory analysis on neuro-specific and inflammatory blood and cerebrospinal fluid markers of COVID-19 infection
Tidsramme: 24 months
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Neuro-specific and inflammatory blood- and cerebrospinal fluid markers in COVID-19 positive patients compared to COVID-19 negative matched controls
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24 months
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Exploratory analysis of the coagulation profile of COVID-19 positive patients compared to COVID-19neg patients
Tidsramme: 24 months
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Functional and immunologic plasma assays will be employed to analyze proteins and pathways in coagulation and fibrinolysis
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24 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Grethe Andersen, MD, Aarhus University Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Coronavirus-infeksjoner
- Coronaviridae-infeksjoner
- Nidovirales infeksjoner
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Luftveisinfeksjoner
- Sykdommer i luftveiene
- Lungebetennelse, viral
- Lungebetennelse
- Lungesykdommer
- Nevrologiske manifestasjoner
- Nevrokognitive lidelser
- Slag
- Epilepsi
- Covid-19
- Sykdommer i nervesystemet
- Kognitiv dysfunksjon
- Anfall
- Kognisjonsforstyrrelser
Andre studie-ID-numre
- Neuro-Covid-19
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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