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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04789447
• Other study ID #: CT-19
• Status: Completed
• Start date: March 4, 2021
• Est. completion date: May 6, 2021

Study information

• Verified date: June 2021
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 895
• Est. completion date: May 6, 2021
• Est. primary completion date: May 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Pneumonia
• Pneumonia, Viral
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
Turkey	Sultan Abdülhamid Han Training and Research Hospital	Istanbul
Turkey	Sultan Abdülhamid Han Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	mortality during hospitalization and within 14 days after hospitalization	up to 30 days
Secondary	need for intensive care	need for intensive care during hospitalization and within 30 days after hospitalization	up to 30 days
Secondary	need for intenvasive mechanical ventilation	need for intenvasive mechanical ventilation during hospitalization and within 30 days after hospitalization	up to 30 days