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

1 de setembro de 2020 atualizado por: 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

Visão geral do estudo

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

Observacional

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

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

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Prevalence of COVID-19 infection in consecutive patients with neurological symptoms
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Three months cognitive function of COVID-19 positive patients
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 24 months
Functional and immunologic plasma assays will be employed to analyze proteins and pathways in coagulation and fibrinolysis
24 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Grethe Andersen, MD, Aarhus University Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Antecipado)

7 de maio de 2020

Conclusão Primária (Antecipado)

29 de novembro de 2020

Conclusão do estudo (Antecipado)

30 de junho de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

29 de abril de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de maio de 2020

Primeira postagem (Real)

6 de maio de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de setembro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de setembro de 2020

Última verificação

1 de setembro de 2020

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

Upon reasonable request

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em COVID-19 swap test PCR

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