COVID-19NCT04424849
Thorax Computed Tomography Severity Score and Outcome in COVID-19 Patients
An observational study of COVID-19, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The most common thorax Computed tomography (CT) findings are multifocal ground-glass opacities and peripheral consolidation in patients with COVID-19. Septal thickening, bronchiectasis, pleural thickening, and subpleural involvement may also be observed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- CT-Scan
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2020to 15 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: Patient admitted to the intensive care unit with COVID-19 pneumonia confirmed by RT-PCR
Who may be able to join
- Age ≥ 18 years
- COVID-19 confirmed by positive RT-PCR and/or antibody testing
- CT scan at intensive care unit admission
Who cannot join
- Loss of CT data
- Chronic lung disease findings by CT that may lead to misinterpretation
- RT-PCR results unavailable or negative
- Terminal cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tepecik Training and Research Hospital
Izmir, Izmir, Konak, 35170
Işıl Köse Güldoğan, +902324330810, isilkose66@hotmail.com
Kazim Rollas, +905532787535, kazim.rollas@yahoo.com
About this study
Official title: Initial Thoracic CT Findings and Mechanical Ventilation Requirement in Patients Admitted to Intensive Care Unit With COVID-19
The most common thorax Computed tomography (CT) findings are multifocal ground-glass opacities and peripheral consolidation in patients with COVID-19. Septal thickening, bronchiectasis, pleural thickening, and subpleural involvement may also be observed. Although these findings are not specific to COVID-19, the severity of pulmonary involvement is expected to be correlated with thorax CT findings.
Read the detailed description
Thorax computed tomography severity score defined by Yang et al. can be used to evaluate the severity of pulmonary involvement in COVID-19 patients. We aimed to investigate whether the initial thorax computed tomography severity score can predict mechanical ventilation requirement and mortality in COVID-19 patients.
- Conditions
- COVID-19
- Being tested
- CT-Scan
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-ScanDiagnostic test
Chest CT scan on admission to the intensive care unit
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients | Patient tested positive for COVID-19 who had a CT scan Receives: Diagnostic Test: CT-Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive respiratory support in patients with COVID-19
Whether Thorax CT findings predict invasive mechanical ventilation requirement of covid-19 patients
Measured: 120 days
Secondary outcomes (1)
Mortality in patients with COVID-19
Whether Thorax CT findings predict mortality of covid-19 patients
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start15 Mar 2020
- Primary completion15 Jun 2020 (estimated)
- Study completion15 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazim Rollas, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424849
- Sponsor's protocol ID
- 2020/5-4
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Thoracic CT Findings and Mechanical Ventilation Requirement in Patients Admitted to Intensive Care Unit With COVID-19
- ClinicalTrials.gov ID
- NCT04424849
- Acronym / sponsor ID
- 2020/5-4
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 15 Jul 2020 (estimated)
- First posted
- 11 Jun 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 most common thorax Computed tomography (CT) findings are multifocal ground-glass opacities and peripheral consolidation in patients with COVID-19. Septal thickening, bronchiectasis, pleural thickening, and subpleural involvement may also be observed. Although these findings are not specific to COVID-19, the severity of pulmonary involvement is expected to be correlated with thorax CT findings.
Detailed description
Thorax computed tomography severity score defined by Yang et al. can be used to evaluate the severity of pulmonary involvement in COVID-19 patients. We aimed to investigate whether the initial thorax computed tomography severity score can predict mechanical ventilation requirement and mortality in COVID-19 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients | – | Diagnostic Test: CT-ScanPatient tested positive for COVID-19 who had a CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted to the intensive care unit with COVID-19 pneumonia confirmed by RT-PCR
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- COVID-19 confirmed by positive RT-PCR and/or antibody testing
- CT scan at intensive care unit admission
Key exclusion criteria (4 listed)
- Loss of CT data
- Chronic lung disease findings by CT that may lead to misinterpretation
- RT-PCR results unavailable or negative
- Terminal cancer
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-ScanChest CT scan on admission to the intensive care unit | Diagnostic test | COVID-19 patients |
Primary outcome
Invasive respiratory support in patients with COVID-19
Time frame: 120 days
Whether Thorax CT findings predict invasive mechanical ventilation requirement of covid-19 patients
1 secondary outcome
Mortality in patients with COVID-19
Time frame: 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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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.
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 COVID-19, run by Tepecik Training and Research Hospital 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Işıl K Güldoğan (02324330810, isilkose66@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive respiratory support in patients with COVID-19 (time frame: 120 days). 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 11 Jun 2020.