Risk Stratification With Chest CT to Rule-out Suspected SARS-CoV-2 Infections (SCout)
Risk Stratification With Chest Computed Tomography to Rule-out Suspected SARS-CoV-2 Infections of Unspecific Symptomatic Patients Before Hospital Admission
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
To prevent spreading of the new coronavirus (SARS-CoV-2) from patients who are infected but in whom infection was not detected by means of Reverse transcription polymerase chain reaction (RT-PCR) and who are to be admitted to ordinary wards of hospitals, we aimed to determine validity of exclusion of pneumonia immediately before admission by means of chest computed tomography.
Patients admitted to the emergency department of the university hospital Jena with Covid-19 symptoms (temperature > 37.5°C; respiratory and/or gastrointestinal symptoms) whose RT-PCR test resulted negative, undergo a chest CT scan. Those patients without pulmonary infiltrates can be safely ruled out for Covid-19. Thus, CT has perfect selectivity evidence regarding pulmonary infiltrates; it has limited selectivity concerning the pathogenesis of the infiltration.
The study objective is to investigate the diagnostic value and consistency of chest CT as compared with comparison to RT-PCR assay in COVID-19 in patients which were stratified for hospital admission.
The hypothesis is that chest CT has the greatest clinical evidence (no detection of lung infiltration) when the RT-PCT is tested negative. We assume that chest CT has a high sensitivity for diagnosis of respiratory dominant COVID-19. A pulmonary COVID-19 in epidemic areas can be best ruled out when chest CT is negative for the presence of infiltrations of the lung parenchyma. This is described by the SNOUT principle which is an acronym for 'Sensitive test when Negative rules OUT the disease' under the condition of a low pretest probability.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Thuringia
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Jena, Thuringia, Alemanha, 07747
- Jena University Hospital
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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:
- ≥ 18 years
- Provided written informed consent
- Intended hospital admission for any reason
- Symptoms that suggest infection with SARS-CoV-2
- Participant agrees to rt PCR and antibody test (SARS-CoV-2)
Exclusion Criteria:
- < 18 years
- Pregnancy cannot be excluded
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.
Prazo: At hospital admission
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Positive likelihood ratio (LR+) Negative likelihood ratio (LR-)
|
At hospital admission
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sensitivity and specificity of chest CT in patients with pulmonary comorbidities
Prazo: At hospital admission
|
Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with pulmonary comorbidities who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.
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At hospital admission
|
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Sensitivity and specificity of chest CT in patients with cardiovascular comorbidities
Prazo: At hospital admission
|
Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with cardiovascular comorbidities who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.
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At hospital admission
|
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Sensitivity and specificity of chest CT in patients with malignancy
Prazo: At hospital admission
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Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with malignancy who are to be admitted to hospital and who are rt-PCR negative for infection with SARS-CoV-2.
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At hospital admission
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Sensitivity and specificity of chest CT in patients with immunodeficiency
Prazo: At hospital admission
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Sensitivity and specificity of chest CT in detecting pneumonia in unspecific symptomatic patients with immunodeficiency who are to be admitted to hospital and who are rt-PCR negative for SARS-CoV-2.
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At hospital admission
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Predictive value of specific chest CT findings for detection of SARS-CoV-2
Prazo: At hospital admission
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Predictive value of chest CT
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At hospital admission
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ulf Teichgräber, Prof. Dr., Department of Radiology, Jena University Hospital, Germany
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- IDIR-001-2020
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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