- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Kontakty a umístění
Studijní místa
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DK
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Aalborg, DK, Dánsko, 9000
- Aalborg University Hospital
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Aarhus, DK, Dánsko, 8200
- Aarhus University Hospital
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Holstebro, DK, Dánsko, 7500
- Regional Hospital West Jutland, Hostebro
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Viborg, DK, Dánsko, 8800
- Regional Hospital Central Jutland, Viborg
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Prevalence of COVID-19 infection in consecutive patients with neurological symptoms
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Three months cognitive function of COVID-19 positive patients
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Grethe Andersen, MD, Aarhus University Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Duševní poruchy
- Kardiovaskulární choroby
- Cévní onemocnění
- Cerebrovaskulární poruchy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Koronavirové infekce
- Infekce Coronaviridae
- Infekce Nidovirales
- RNA virové infekce
- Virová onemocnění
- Infekce
- Infekce dýchacích cest
- Nemoci dýchacích cest
- Pneumonie, virová
- Zápal plic
- Plicní onemocnění
- Neurologické projevy
- Neurokognitivní poruchy
- Mrtvice
- Epilepsie
- COVID-19
- Nemoci nervového systému
- Kognitivní dysfunkce
- Záchvaty
- Poruchy kognice
Další identifikační čísla studie
- Neuro-Covid-19
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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