SCout: Risk Stratification With Chest CT to Rule-out Suspected SARS-CoV-2 Infections

Sponsor

Jena University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04357938

Collaborator

(none)

145

Enrollment

Location

2.5

Actual Duration (Months)

58.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Acute Respiratory Syndrome Coronavirus 2	Device: CT-imaging

Detailed Description

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 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.

Study Design

Study Type:

Observational

Actual Enrollment :

145 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 15, 2020

Actual Primary Completion Date :

May 20, 2020

Actual Study Completion Date :

Jun 30, 2020

Outcome Measures

Primary Outcome Measures

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. [At hospital admission]
Positive likelihood ratio (LR+) Negative likelihood ratio (LR-)

Secondary Outcome Measures

Sensitivity and specificity of chest CT in patients with pulmonary comorbidities [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.
Sensitivity and specificity of chest CT in patients with cardiovascular comorbidities [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.
Sensitivity and specificity of chest CT in patients with malignancy [At hospital admission]
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.
Sensitivity and specificity of chest CT in patients with immunodeficiency [At hospital admission]
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.

Other Outcome Measures

Predictive value of specific chest CT findings for detection of SARS-CoV-2 [At hospital admission]
Predictive value of chest CT

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jena University Hospital	Jena	Thuringia	Germany	07747

Sponsors and Collaborators

Jena University Hospital

Investigators

Principal Investigator: Ulf Teichgräber, Prof. Dr., Department of Radiology, Jena University Hospital, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ulf Teichgräber, Professor of Radiology, Chairman of Radiology Dep., Jena University Hospital

ClinicalTrials.gov Identifier:

NCT04357938

Other Study ID Numbers:

IDIR-001-2020

First Posted:

Apr 22, 2020

Last Update Posted:

Sep 20, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Severe Acute Respiratory Syndrome

Study Results

No Results Posted as of Sep 20, 2021