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

Severe Acute Respiratory Syndrome Coronavirus 2 Clinical Trial

— SCout  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357938
• Other study ID #: IDIR-001-2020
• Status: Completed
• Start date: April 15, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2021
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: June 30, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2

Intervention

Device:
• CT-imaging
Chest CT to rule out pneumonia in PCR negative, nonspecific symptomatic patients to prevent the spread of SARS-CoV-2 within the hospital.

Locations

Country	Name	City	State
Germany	Jena University Hospital	Jena	Thuringia

Sponsors (1)

Lead Sponsor	Collaborator
Jena University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Predictive value of specific chest CT findings for detection of SARS-CoV-2	Predictive value of chest CT	At hospital admission
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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