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- Ensaio Clínico 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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Contactos e Locais
Locais de estudo
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DK
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Aalborg, DK, Dinamarca, 9000
- Aalborg University Hospital
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Aarhus, DK, Dinamarca, 8200
- Aarhus University Hospital
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Holstebro, DK, Dinamarca, 7500
- Regional Hospital West Jutland, Hostebro
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Viborg, DK, Dinamarca, 8800
- Regional Hospital Central Jutland, Viborg
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Prevalence of COVID-19 infection in consecutive patients with neurological symptoms
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Three months cognitive function of COVID-19 positive patients
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Grethe Andersen, MD, Aarhus University Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Doenças cardiovasculares
- Doenças Vasculares
- Distúrbios Cerebrovasculares
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Infecções por coronavírus
- Infecções por Coronaviridae
- Infecções por Nidovírus
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções do Trato Respiratório
- Doenças Respiratórias
- Pneumonia Viral
- Pneumonia
- Doenças pulmonares
- Manifestações Neurológicas
- Distúrbios Neurocognitivos
- Derrame
- Epilepsia
- COVID-19
- Doenças do Sistema Nervoso
- Disfunção cognitiva
- Convulsões
- Distúrbios Cognitivos
Outros números de identificação do estudo
- Neuro-Covid-19
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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