Covid19NCT04754633
Comparison of Chest CT Findings Related to COVID-19 With RSNA and BSTI Guidelines
An observational study of Covid19 and Infection Viral, run by Seyhmus Kavak at 1 site in Turkey (Türkiye).
Trial summary
To present the first admission chest computed tomography (CT) findings of patients followed up with a diagnosis of COVID-19, and to compare the two classification systems by evaluating these findings according to the BSTI and RSNA guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Infection Viral, CT Scan
- How many people
- 764 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 20 Jul 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: Subjects who applied to the emergency department with the diagnosis of COVID-19 and had chest CT examination between 07.01.2020 and 07.20.2020.
Who may be able to join
- Who had single negative RT-PCR
- Non-optimal chest CT , insufficient data
- <18 age of year
- Thoracic trauma
- Chest CT Negative
Who cannot join
- RT-PCR positive and chest CT positive findings
- At least two RT-PCR negative and chest CT positive findings
- >18 age of year
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlik Bilimleri Üniversitesi Training and Research Hospital
Diyarbakır, 21600
About this study
Official title: Comparison of Chest CT Findings Related to COVID-19 With RSNA and BSTI Guidelines: Correlation Between Radiologists
To present the first admission chest computed tomography (CT) findings of patients followed up with a diagnosis of COVID-19, and to compare the two classification systems by evaluating these findings according to the BSTI and RSNA guidelines.
Read the detailed description
A total of 764 adult patients who were diagnosed with COVID-19 inpatient of researchers' hospital 2020 were included in this study. The findings were recorded as typical, indeterminate, and atypical by the RSNA guidelines and as classical COVID-19, possible COVID-19, indeterminate, and non-COVID-19 by the BSTI classification. The data obtained according to both classification systems were compared with each other.
- Conditions
- Covid19, Infection Viral, CT Scan
- Keywords
- Coronavirus, Computed Thomography, PCR
- Medical subject headings
- COVID-19, Virus Diseases, Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Current study evaluating the success of the guidelines recommended by RSNA and BSTI in detecting COVID-19 disease
Kappa correlation analysis was performed between radiologists in the evaluation of chest CT findings of COVID-19 disease according to BSTI and RSNA guidelines.
Measured: 1st week from the moment of first admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Jul 2020
- Primary completion20 Jul 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seyhmus Kavak
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Responsible party
- Sponsor-investigator, Seyhmus Kavak, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754633
- Sponsor's protocol ID
- 2020/588
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Chest CT Findings Related to COVID-19 With RSNA and BSTI Guidelines: Correlation Between Radiologists
- ClinicalTrials.gov ID
- NCT04754633
- Acronym / sponsor ID
- 2020/588
- Conditions
- Covid19, Infection Viral, CT Scan
- Keywords
- Coronavirus, Computed Thomography, PCR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 764 participants (actual)
- Lead sponsor
- Seyhmus KavakUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 15 Feb 2021 (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.
To present the first admission chest computed tomography (CT) findings of patients followed up with a diagnosis of COVID-19, and to compare the two classification systems by evaluating these findings according to the BSTI and RSNA guidelines.
Detailed description
A total of 764 adult patients who were diagnosed with COVID-19 inpatient of researchers' hospital 2020 were included in this study. The findings were recorded as typical, indeterminate, and atypical by the RSNA guidelines and as classical COVID-19, possible COVID-19, indeterminate, and non-COVID-19 by the BSTI classification. The data obtained according to both classification systems were compared with each other.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who applied to the emergency department with the diagnosis of COVID-19 and had chest CT examination between 07.01.2020 and 07.20.2020.
Key inclusion criteria (5 listed)
- Who had single negative RT-PCR
- Non-optimal chest CT , insufficient data
- <18 age of year
- Thoracic trauma
- Chest CT Negative
Key exclusion criteria (3 listed)
- RT-PCR positive and chest CT positive findings
- At least two RT-PCR negative and chest CT positive findings
- >18 age of year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Current study evaluating the success of the guidelines recommended by RSNA and BSTI in detecting COVID-19 disease
Time frame: 1st week from the moment of first admission
Kappa correlation analysis was performed between radiologists in the evaluation of chest CT findings of COVID-19 disease according to BSTI and RSNA guidelines.
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 15 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19 and Infection Viral, run by Seyhmus Kavak at 1 site in Turkey (Türkiye).
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 3 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 15 Feb 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 Turkey (Türkiye). 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?
Current study evaluating the success of the guidelines recommended by RSNA and BSTI in detecting COVID-19 disease (time frame: 1st week from the moment of first admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2021.