Severe Acute Respiratory Syndrome Coronavirus 2 Clinical Trial
— SCoutOfficial title:
Risk Stratification With Chest Computed Tomography to Rule-out Suspected SARS-CoV-2 Infections of Unspecific Symptomatic Patients Before Hospital Admission
NCT number | NCT04357938 |
Other study ID # | IDIR-001-2020 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 15, 2020 |
Est. completion date | June 30, 2020 |
Verified date | September 2021 |
Source | Jena University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 145 |
Est. completion date | June 30, 2020 |
Est. primary completion date | May 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Jena University Hospital | Jena | Thuringia |
Lead Sponsor | Collaborator |
---|---|
Jena University Hospital |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Predictive value of specific chest CT findings for detection of SARS-CoV-2 | Predictive value of chest CT | At hospital admission | |
Primary | 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 | Sensitivity and specificity of chest CT in patients with pulmonary comorbidities | 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. | At hospital admission | |
Secondary | Sensitivity and specificity of chest CT in patients with cardiovascular comorbidities | 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. | At hospital admission | |
Secondary | Sensitivity and specificity of chest CT in patients with malignancy | 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. | At hospital admission | |
Secondary | Sensitivity and specificity of chest CT in patients with immunodeficiency | 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. | At hospital admission |
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