跳至主要内容
临床试验/NCT04357938
NCT04357938已完成不适用

Risk Stratification With Chest Computed Tomography to Rule-out Suspected SARS-CoV-2 Infections of Unspecific Symptomatic Patients Before Hospital Admission

Jena University Hospital1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2020年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
145
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 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)

排除标准

  • < 18 years
  • Pregnancy cannot be excluded

结局指标

主要结局

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.

时间窗: At hospital admission

Positive likelihood ratio (LR+) Negative likelihood ratio (LR-)

次要结局

  • Sensitivity and specificity of chest CT in patients with cardiovascular comorbidities(At hospital admission)
  • Sensitivity and specificity of chest CT in patients with malignancy(At hospital admission)
  • Sensitivity and specificity of chest CT in patients with immunodeficiency(At hospital admission)
  • Sensitivity and specificity of chest CT in patients with pulmonary comorbidities(At hospital admission)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ulf Teichgräber

Professor of Radiology, Chairman of Radiology Dep.

Jena University Hospital

研究点 (1)

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