Covid19NCT04789447
Initial CT Findings and CO-RADS Stage in COVID-19
An observational study of Covid19 and SARS-CoV Infection, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to determine whether patients with different real-time reverse transcriptase-polymerase chain reaction (PCR), chest computed tomography (CT) and laboratory findings have different clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, SARS-CoV Infection, Pneumonia, Viral
- How many people
- 895 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 4 Mar 2021to 6 May 2021
- 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 who are diagnosed with Covid-19 in a two tertier hospital in Turkey
Who may be able to join
- Aged 18 years and over,
- Having SARS-CoV-2 RT-PCR test and chest CT examinations performed at the time of application or within 24 hours after admission
- RT-PCR positivity in nasopharyngeal swabs sample, and/or the presence of clinical and laboratory findings of SARS-CoV-2 infection and/or the presence of COVID-19-compatible radiological findings in chest CT, and being diagnosed with COVID-19
Who cannot join
- Patients with negative SARS-CoV-2 PCR test, pneumonia on CT but not given Covid-19 treatment by not considering Covid-19 by their doctor will not be included.
- Patients whose data are not available
- Patients with poor CT image quality
- Patients who were transferred to another hospital
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Sultan Abdülhamid Han Training and Research Hospital
Istanbul, 34660
Sultan Abdülhamid Han Training and Research Hospital
Istanbul
About this study
Official title: Comparison of Initial CT Findings and CO-RADS Stage in COVID-19 Patients With PCR, Inflammation and Coagulation Parameters in Diagnostic and Prognostic Perspectives
This study aims to determine whether patients with different real-time reverse transcriptase-polymerase chain reaction (PCR), chest computed tomography (CT) and laboratory findings have different clinical outcomes.
Read the detailed description
This study aims to determine the rates of PCR positivity and CT findings in hospitalized patients with a diagnosis of COVID-19, to determine whether there is a difference in mortality and need for ICU between patients grouped according to the PCR positivity and presence of CT findings, and to evaluate the effect of the CO-RADS stage on these outcomes. Moreover, it is to compare the effects of inflammation and coagulation markers and CO-RADS stage on the severity of the disease
- Conditions
- Covid19, SARS-CoV Infection, Pneumonia, Viral
- Keywords
- COVID-19, SARS-CoV2 RT-PCR Testing, Thorax, Computerized Tomography, Mortality, Prognosis
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients in hospital | All patients aged 18 years and over, positive for SARS-CoV-2 PCR test and / or Covid-19 treatment with signs of Covid-19 disease on CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
mortality during hospitalization and within 14 days after hospitalization
Measured: up to 30 days
Secondary outcomes (2)
need for intensive care
need for intensive care during hospitalization and within 30 days after hospitalization
Measured: up to 30 days
need for intenvasive mechanical ventilation
need for intenvasive mechanical ventilation during hospitalization and within 30 days after hospitalization
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start4 Mar 2021
- Primary completion6 May 2021
- Study completion6 May 2021
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 895 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Yıldırım Ayaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Elif Yıldırım Ayaz, M.D., Principal investigator, Sultan Abdülhamid Han Training and Rsearch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789447
- Sponsor's protocol ID
- CT-19
- Status last verified
- Jun 2021
- First submitted
- 4 Mar 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Initial CT Findings and CO-RADS Stage in COVID-19 Patients With PCR, Inflammation and Coagulation Parameters in Diagnostic and Prognostic Perspectives
- ClinicalTrials.gov ID
- NCT04789447
- Acronym / sponsor ID
- CT-19
- Conditions
- Covid19, SARS-CoV Infection, Pneumonia, Viral
- Keywords
- COVID-19, SARS-CoV2 RT-PCR Testing, Thorax, Computerized Tomography, Mortality, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 895 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 9 Mar 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.
This study aims to determine whether patients with different real-time reverse transcriptase-polymerase chain reaction (PCR), chest computed tomography (CT) and laboratory findings have different clinical outcomes.
Detailed description
This study aims to determine the rates of PCR positivity and CT findings in hospitalized patients with a diagnosis of COVID-19, to determine whether there is a difference in mortality and need for ICU between patients grouped according to the PCR positivity and presence of CT findings, and to evaluate the effect of the CO-RADS stage on these outcomes. Moreover, it is to compare the effects of inflammation and coagulation markers and CO-RADS stage on the severity of the disease
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients in hospital | – | –All patients aged 18 years and over, positive for SARS-CoV-2 PCR test and / or Covid-19 treatment with signs of Covid-19 disease on CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed with Covid-19 in a two tertier hospital in Turkey
Key inclusion criteria (3 listed)
- Aged 18 years and over,
- Having SARS-CoV-2 RT-PCR test and chest CT examinations performed at the time of application or within 24 hours after admission
- RT-PCR positivity in nasopharyngeal swabs sample, and/or the presence of clinical and laboratory findings of SARS-CoV-2 infection and/or the presence of COVID-19-compatible radiological findings in chest CT, and being diagnosed with COVID-19
Key exclusion criteria (4 listed)
- Patients with negative SARS-CoV-2 PCR test, pneumonia on CT but not given Covid-19 treatment by not considering Covid-19 by their doctor will not be included.
- Patients whose data are not available
- Patients with poor CT image quality
- Patients who were transferred to another hospital
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
mortality
Time frame: up to 30 days
mortality during hospitalization and within 14 days after hospitalization
2 secondary outcomes
need for intensive care
Time frame: up to 30 days
need for intenvasive mechanical ventilation
Time frame: up to 30 days
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 9 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Elif Yıldırım Ayaz, M.D. principal investigator
Sultan Abdülhamid Han Training and Rsearch Hospital
2 sites 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 SARS-CoV Infection, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 2 sites 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: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
mortality (time frame: up to 30 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 9 Jun 2021.