- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT05025839
Neurological Outcome After SARS-CoV-2 Infection (ATTRACT)
Long-term Neurological Outcome After SARS-CoV-2 Infection
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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Tyrol
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Innsbruck, Tyrol, Áustria, 6020
- Recrutamento
- Medical University Innsbruck, Department of Neurology
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Contato:
- Raimund Helbok, Priv.Doz. Dr.
- Número de telefone: 81689 +43 50 504
- E-mail: raimund.helbok@tirol-kliniken.at
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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
Descrição
Inclusion Criteria:
- (1) Patients of either sex, aged ≥18 years with
- (2) confirmed SARS-CoV-2 infection (according to the Austrian Federal Ministry of Social Affairs, Health, Care and Consumer Protection),
- (3) signed and dated declaration of consent by the patient according to ICH-GCP Guidelines,
- (4) being able to speak and understand the German language
Exclusion Criteria:
- (1) Pre-existing dementia,
- (2) confirmed pregnancy,
- (3) patients without the capacity to consent,
- (4) asymptomatic patients,
- (5) patients not presenting to the hospital
Specific Inclusion/exclusion criteria for the MRI substudy
Inclusion criteria:
- (1) Patients of either sex, aged ≥18 years with
- (2) confirmed SARS-CoV-2 infection (according to the Austrian Federal Ministry of Social Affairs, Health, Care and Consumer Protection),
- (3) signed and dated declaration of consent by the patient according to ICH-GCP Guidelines,
- (4) being able to speak and understand the German language
- (5) agree to participate for MRI
Exclusion criteria:
- (1) Pre-existing dementia,
- (2) confirmed pregnancy,
- (3) patients without the capacity to consent,
- (4) asymptomatic patients,
- (5) patients not presenting to the hospital
- (6) definite contraindication to MRI (e.g. pacemakers)
Controls Patients after pneumonia (Cpneum) We will enrol at least 50 hospitalized age- and sex matched patients with pneumonia based on disease severity during the acute disease as: (group One) hospitalized (moderate; n=25) and (group two) severe patients admitted to the ICU for mechanical ventilation (n=25).
Inclusion criteria:
- (1) Patients of either sex, aged ≥18 years with
- (2) bacterial pneumonia according to CDC criteria,
- (3) signed and dated declaration of consent by the patient according to ICH-GCP Guidelines, and
- (4) being able to speak and understand the German language,
- (5) agree to participate for MRI
Exclusion criteria:
- (1) Pre-existing dementia,
- (2) confirmed pregnancy,
- (3) patients without the capacity to consent,
- (4) definite contraindication to MRI (e.g. pacemakers)
Healthy referents (Chealthy) Currently n=38 MRI acquisitions of prospectively recruited healthy individuals are available, fulfilling the criteria of this proposal (age- and sex matched; same MR protocol). This cohort will be prospectively extended by n=42 to reach age and sex matched criteria.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Controle de caso
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
C healthy
Healthy control group
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No Intervention takes place, Patients are being observed and classified according to disease severity
Outros nomes:
|
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C pneum
Control group of patients who were hospitalised and diagnosed with pneumonia ( COVID-19 pneumonia excluded)
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No Intervention takes place, Patients are being observed and classified according to disease severity
Outros nomes:
|
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Mild
Outpatients presenting to the hospital with COVID-19
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No Intervention takes place, Patients are being observed and classified according to disease severity
Outros nomes:
|
|
Moderate
In-patients with COVID-19 not requiring ICU admission
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No Intervention takes place, Patients are being observed and classified according to disease severity
Outros nomes:
|
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Severe
Patients with COVID-19 admitted to the ICU
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No Intervention takes place, Patients are being observed and classified according to disease severity
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Prevalence of neurological manifestations in COVID-19 patients
Prazo: 3-months
|
3-month prevalence of neurological manifestations in COVID-19 patients presenting to the hospital in comparison to control patients (Cpneum)
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3-months
|
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Prevalence of neurological manifestations in COVID-19 patients
Prazo: 12-months
|
12-month prevalence of neurological manifestations in COVID-19 patients presenting to the hospital in comparison to control patients (Cpneum)
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12-months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Association, prevalence and classification of neurologic manifestations with structural neuroimaging in hospitalised COVID-19 patients after 3-months.
Prazo: 3-months
|
Association of neurologic manifestations (specifically neuropsychological deficits and smelling deficits) with structural neuroimaging (high-field MRI) in comparison to control patients (Cpneum).
Prevalence and classification of neuroimaging abnormalities in hospitalized COVID-19 patients in comparison to controls (Cpneum and Chealthy).
Other (exploratory) endpoints derived from the clinical database might be analyzed on data driven considerations 3-months after acute disease.
|
3-months
|
|
Association, prevalence and classification of neurologic manifestations with structural neuroimaging in hospitalised COVID-19 patients after 12-months.
Prazo: 12-months
|
Association of neurologic manifestations (specifically neuropsychological deficits and smelling deficits) with structural neuroimaging (high-field MRI) in comparison to control patients (Cpneum).
Prevalence and classification of neuroimaging abnormalities in hospitalized COVID-19 patients in comparison to controls (Cpneum and Chealthy).
Other (exploratory) endpoints derived from the clinical database might be analyzed on data driven considerations 12-months after acute disease.
|
12-months
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KLI 986
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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