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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-imaging | Device | Chest CT to rule out pneumonia in PCR negative, nonspecific symptomatic patients to prevent the spread of SARS-CoV-2 within the hospital. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Positive likelihood ratio (LR+) Negative likelihood ratio (LR-) | At hospital admission |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of chest CT in patients with pulmonary comorbidities | 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. | At hospital admission |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive value of specific chest CT findings for detection of SARS-CoV-2 | Predictive value of chest CT | At hospital admission |
Inclusion Criteria:
Exclusion Criteria:
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Patients with unspecific symptoms of SARS-CoV-2 infection who are to be admitted to hospital for any disease and who provide written informed consent to undergo rt-PCR, chest CT, and antibody test.
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| Name | Affiliation | Role |
|---|---|---|
| Ulf Teichgräber, Prof. Dr. | Department of Radiology, Jena University Hospital, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jena University Hospital | Jena | Thuringia | 07747 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33435973 | Derived | Teichgraber U, Malouhi A, Ingwersen M, Neumann R, Reljic M, Deinhardt-Emmer S, Loffler B, Behringer W, Lewejohann JC, Stallmach A, Reuken P. Ruling out COVID-19 by chest CT at emergency admission when prevalence is low: the prospective, observational SCOUT study. Respir Res. 2021 Jan 12;22(1):13. doi: 10.1186/s12931-020-01611-w. |
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There is not a plan to make IPD available.
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| ID | Term |
|---|---|
| D000097873 | Postmortem Imaging |
| ID | Term |
|---|---|
| D001344 | Autopsy |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003952 | Diagnostic Imaging |
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| Sensitivity and specificity of chest CT in patients with cardiovascular comorbidities |
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. |
| At hospital admission |
| Sensitivity and specificity of chest CT in patients with malignancy | 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. | At hospital admission |
| Sensitivity and specificity of chest CT in patients with immunodeficiency | 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. | At hospital admission |
| D008919 |
| Investigative Techniques |