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

J

Jena University Hospital

Status

Completed

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Treatments

Device: CT-imaging

Study type

Observational

Funder types

Other

Identifiers

NCT04357938
IDIR-001-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

145 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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