Clinical trial NCT04357938: Risk Stratification With Chest CT to Rule-out Suspected SARS-CoV-2 Infections
Official title: Risk Stratification With Chest Computed Tomography to Rule-out Suspected SARS-CoV-2 Infections of Unspecific Symptomatic Patients Before Hospital Admission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: 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.
timeFrame: At hospital admission
Secondary outcomes:
measure: Sensitivity and specificity of chest CT in patients with pulmonary comorbidities
timeFrame: At hospital admission
measure: Sensitivity and specificity of chest CT in patients with cardiovascular comorbidities
timeFrame: At hospital admission
measure: Sensitivity and specificity of chest CT in patients with malignancy
timeFrame: At hospital admission
measure: Sensitivity and specificity of chest CT in patients with immunodeficiency
timeFrame: At hospital admission
Other outcomes:
measure: Predictive value of specific chest CT findings for detection of SARS-CoV-2
timeFrame: At hospital admission
Locations:
city: Jena
country: Germany
facility: Jena University Hospital
state: Thuringia
Study officials:
affiliation: Department of Radiology, Jena University Hospital, Germany
name: Ulf Teichgräber, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.