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

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 Disease	Intervention/Treatment	Phase
Covid19 SARS-CoV Infection Pneumonia, Viral

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

Arm	Intervention/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

mortality [up to 30 days]
mortality during hospitalization and within 14 days after hospitalization

Secondary Outcome Measures

need for intensive care [up to 30 days]
need for intensive care during hospitalization and within 30 days after hospitalization
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:

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