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

NCT ID: NCT04357938

Last Updated: 2021-09-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 145 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-15
• Study Completion Date: 2020-06-30

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.

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 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.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Chest computed tomography

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jena University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ulf Teichgräber

Professor of Radiology, Chairman of Radiology Dep.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulf Teichgräber, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Radiology, Jena University Hospital, Germany

Locations

Jena University Hospital

Jena, Thuringia, Germany

Countries

Germany

References

Teichgraber U, Malouhi A, Ingwersen M, Neumann R, Reljic M, Deinhardt-Emmer S, Loffler B, Behringer W, Lewejohann JC, Stallmach A, Reuken P. Ruling out COVID-19 by chest CT at emergency admission when prevalence is low: the prospective, observational SCOUT study. Respir Res. 2021 Jan 12;22(1):13. doi: 10.1186/s12931-020-01611-w.

Reference Type: DERIVED

PMID: 33435973 (View on PubMed)

Other Identifiers

IDIR-001-2020

Identifier Type: -

Identifier Source: org_study_id