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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Thuringia
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Jena, Thuringia, Duitsland, 07747
- Jena University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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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.
Tijdsspanne: At hospital admission
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Positive likelihood ratio (LR+) Negative likelihood ratio (LR-)
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At hospital admission
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Sensitivity and specificity of chest CT in patients with pulmonary comorbidities
Tijdsspanne: At hospital admission
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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
Tijdsspanne: At hospital admission
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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
Tijdsspanne: 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
Tijdsspanne: 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
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Predictive value of specific chest CT findings for detection of SARS-CoV-2
Tijdsspanne: At hospital admission
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Predictive value of chest CT
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At hospital admission
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ulf Teichgräber, Prof. Dr., Department of Radiology, Jena University Hospital, Germany
Publicaties en nuttige links
Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
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Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IDIR-001-2020
Plan Individuele Deelnemersgegevens (IPD)
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