- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04424849
Thorax Computed Tomography Severity Score and Outcome in COVID-19 Patients
June 8, 2020 updated by: Kazim Rollas, Tepecik Training and Research Hospital
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.
Study Overview
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 Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Izmir, Konak
-
Izmir, Izmir, Konak, Turkey, 35170
- Recruiting
- Tepecik Training and Research Hospital
-
Contact:
- Işıl Köse Güldoğan
- Phone Number: +902324330810
- Email: isilkose66@hotmail.com
-
Contact:
- KAZIM ROLLAS
- Phone Number: +905532787535
- Email: kazim.rollas@yahoo.com
-
Principal Investigator:
- Işıl Köse Güldoğan
-
Sub-Investigator:
- Yeliz Pekçevik
-
Sub-Investigator:
- Naciye Sinem GEZER
-
Sub-Investigator:
- Kazım Rollas
-
Sub-Investigator:
- Çiler Zincircioğlu
-
Sub-Investigator:
- Uğur Uzun
-
Sub-Investigator:
- İsa Sahar
-
Sub-Investigator:
- Taner Çalışkan
-
Sub-Investigator:
- Aykut Sarıtaş
-
Sub-Investigator:
- Nimet Şenoğlu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient admitted to the intensive care unit with COVID-19 pneumonia confirmed by RT-PCR
Description
Inclusion Criteria:
- Age ≥ 18 years
- COVID-19 confirmed by positive RT-PCR and/or antibody testing
- CT scan at intensive care unit admission
Exclusion Criteria:
- Loss of CT data
- Chronic lung disease findings by CT that may lead to misinterpretation
- RT-PCR results unavailable or negative
- Terminal cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
COVID-19 patients
Patient tested positive for COVID-19 who had a CT scan
|
Chest CT scan on admission to the intensive care unit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
120 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality in patients with COVID-19
Time Frame: 120 days
|
Whether Thorax CT findings predict mortality of covid-19 patients
|
120 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2020
Primary Completion (Anticipated)
June 15, 2020
Study Completion (Anticipated)
July 15, 2020
Study Registration Dates
First Submitted
June 8, 2020
First Submitted That Met QC Criteria
June 8, 2020
First Posted (Actual)
June 11, 2020
Study Record Updates
Last Update Posted (Actual)
June 11, 2020
Last Update Submitted That Met QC Criteria
June 8, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/5-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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