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

NCT04357938 | Completed

• 1 other identifier: IDIR-001-2020
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Outcome Measures

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.

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

  At hospital admission

Secondary Outcomes (4)

• Sensitivity and specificity of chest CT in patients with pulmonary comorbidities

  At hospital admission

• Sensitivity and specificity of chest CT in patients with cardiovascular comorbidities

  At hospital admission

• Sensitivity and specificity of chest CT in patients with malignancy

  At hospital admission

• Sensitivity and specificity of chest CT in patients with immunodeficiency

  At hospital admission

Other Outcomes (1)

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

  At hospital admission

Interventions

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.

Also known as: Chest computed tomography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with unspecific symptoms of SARS-CoV-2 infection who are to be admitted to hospital for any disease and who provide written informed consent to undergo rt-PCR, chest CT, and antibody test.

You may qualify if:

• ≥ 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)

You may not qualify if:

• \< 18 years
• Pregnancy cannot be excluded

Sponsors & Collaborators

• Jena University Hospital: lead

Study Sites (1)

Jena University Hospital

Jena, Thuringia, 07747, Germany

Location

Related Publications (1)

• 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.

  PMID: 33435973 DERIVED

MeSH Terms

Interventions

Postmortem Imaging

Intervention Hierarchy (Ancestors)

Autopsy; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Investigative Techniques

Study Officials

• Ulf Teichgräber, Prof. Dr.

  Department of Radiology, Jena University Hospital, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology, Chairman of Radiology Dep.

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: April 15, 2020
• Primary Completion: May 20, 2020
• Study Completion: June 30, 2020
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)