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Completed

NCT Number: NCT04357938

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jena University Hospital

Jena, Thuringia, 07747, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Chest computed tomography

Primary outcomes

  1. 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.

    Time frame: At hospital admission

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

Secondary outcomes

  1. Sensitivity and specificity of chest CT in patients with pulmonary comorbidities

    Time frame: 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.

  2. Sensitivity and specificity of chest CT in patients with cardiovascular comorbidities

    Time frame: 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.

  3. Sensitivity and specificity of chest CT in patients with malignancy

    Time frame: 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.

  4. Sensitivity and specificity of chest CT in patients with immunodeficiency

    Time frame: 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 outcomes

  1. Predictive value of specific chest CT findings for detection of SARS-CoV-2

    Time frame: At hospital admission

    Predictive value of chest CT

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Registry information

Official study title

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

Acronym: SCout

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2020
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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