Initial CT Findings and CO-RADS Stage in COVID-19

June 4, 2021 updated by: Elif Yıldırım Ayaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

895

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

  • Turkey
      • Istanbul, Turkey, 34660
        • Sultan Abdülhamid Han Training and Research Hospital
      • Istanbul, Turkey
        • Sultan Abdülhamid Han Training and Research Hospital

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

Patients who are diagnosed with Covid-19 in a two tertier hospital in Turkey

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: up to 30 days
mortality during hospitalization and within 14 days after hospitalization
up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
need for intensive care
Time Frame: up to 30 days
need for intensive care during hospitalization and within 30 days after hospitalization
up to 30 days
need for intenvasive mechanical ventilation
Time Frame: up to 30 days
need for intenvasive mechanical ventilation during hospitalization and within 30 days after hospitalization
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

  • Principal Investigator: Elif Yıldırım Ayaz, M.D., Sultan Abdülhamid Han Training and Rsearch Hospital

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 4, 2021

Primary Completion (Actual)

May 6, 2021

Study Completion (Actual)

May 6, 2021

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

June 9, 2021

Last Update Submitted That Met QC Criteria

June 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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