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

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
Overall Status
Completed
CT.gov ID
NCT04789447
Collaborator
(none)
895
Enrollment
2
Locations
2.1
Actual Duration (Months)
447.5
Patients Per Site
216.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase

    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

    Study Type:
    Observational
    Actual Enrollment :
    895 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Mar 4, 2021
    Actual Primary Completion Date :
    May 6, 2021
    Actual Study Completion Date :
    May 6, 2021

    Arms and Interventions

    ArmIntervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. mortality [up to 30 days]

      mortality during hospitalization and within 14 days after hospitalization

    Secondary Outcome Measures

    1. need for intensive care [up to 30 days]

      need for intensive care during hospitalization and within 30 days after hospitalization

    2. need for intenvasive mechanical ventilation [up to 30 days]

      need for intenvasive mechanical ventilation during hospitalization and within 30 days after hospitalization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Sultan Abdülhamid Han Training and Research HospitalIstanbulTurkey34660
    2Sultan Abdülhamid Han Training and Research HospitalIstanbulTurkey

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elif Yıldırım Ayaz, Principal Investigator, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
    ClinicalTrials.gov Identifier:
    NCT04789447
    Other Study ID Numbers:
    • CT-19
    First Posted:
    Mar 9, 2021
    Last Update Posted:
    Jun 9, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Elif Yıldırım Ayaz, Principal Investigator, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 9, 2021