Severe Acute Respiratory Syndrome Coronavirus 2SCoutNCT04357938
Risk Stratification With Chest CT to Rule-out Suspected SARS-CoV-2 Infections
An observational study of Severe Acute Respiratory Syndrome Coronavirus 2, run by Jena University Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2
- What is being tested?
- CT-imaging
- Type of treatment
- Medical device
- How many people
- 145 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2020to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 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)
Who cannot join
- < 18 years
- Pregnancy cannot be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Stratification With Chest Computed Tomography to Rule-out Suspected SARS-CoV-2 Infections of Unspecific Symptomatic Patients Before Hospital Admission
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.
Read the 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.
- Being tested
- CT-imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-imagingDevice
Also called Chest computed tomography
Chest CT to rule out pneumonia in PCR negative, nonspecific symptomatic patients to prevent the spread of SARS-CoV-2 within the hospital.
What is being measured
The primary outcome is the main question the study is designed to answer.
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-)
Measured: At hospital admission
Secondary outcomes (4)
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.
Measured: At hospital admission
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.
Measured: At hospital admission
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.
Measured: At hospital admission
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.
Measured: At hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start15 Apr 2020
- Primary completion20 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulf Teichgräber, Jena University Hospital
- Investigators
- Ulf Teichgräber, Prof. Dr., Principal investigator, Department of Radiology, Jena University Hospital, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357938
- Sponsor's protocol ID
- IDIR-001-2020
- Acronym
- SCout
- Status last verified
- Sep 2021
- First submitted
- 20 Apr 2020
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
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.
PubMed 33435973
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification With Chest Computed Tomography to Rule-out Suspected SARS-CoV-2 Infections of Unspecific Symptomatic Patients Before Hospital Admission
- ClinicalTrials.gov ID
- NCT04357938
- Acronym / sponsor ID
- SCout / IDIR-001-2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- ≥ 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)
Key exclusion criteria (2 listed)
- < 18 years
- Pregnancy cannot be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-imagingAlso: Chest computed tomographyChest CT to rule out pneumonia in PCR negative, nonspecific symptomatic patients to prevent the spread of SARS-CoV-2 within the hospital. | Device | – |
Primary outcome
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.
Time frame: At hospital admission
Positive likelihood ratio (LR+) Negative likelihood ratio (LR-)
4 secondary outcomes
Sensitivity and specificity of chest CT in patients with pulmonary comorbidities
Time frame: At hospital admission
Sensitivity and specificity of chest CT in patients with cardiovascular comorbidities
Time frame: At hospital admission
Sensitivity and specificity of chest CT in patients with malignancy
Time frame: At hospital admission
Sensitivity and specificity of chest CT in patients with immunodeficiency
Time frame: At hospital admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Derived from this study: PubMed 33435973Teichgraber 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf Teichgräber, Prof. Dr. principal investigator
Department of Radiology, Jena University Hospital, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Acute Respiratory Syndrome Coronavirus 2, run by Jena University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: At hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04357938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.