Identify Coronavirus Disease by Chest X-ray

January 27, 2022 updated by: Mohamed Abdelwahab Elsadek Ibrahim, Assiut University

Diagnostic Accuracy of Chest X-ray in Coronavirus Disease 2019

to identify the diagnostic accuracy of chest X-ray in diagnosis of Coronavirus disease19 .

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The pandemic related to the coronavirus is now considered one of the deadliest epidemics. The numbers of cases exponentially increased with no specific treatment, creating havoc for the health and financial systems of the world [1-6]. Wuhan, the capital city of Hubei in China, reported the earliest cases that were treated as an unusual pneumonia. With the disease progression, the World Health Organization (WHO) announced the presence of several similar cases [7, 8]. Researchers revealed that a novel strain of the family Coronaviridae is the pathogen responsible for the respiratory illness of this disease and this is simulating two previous epidemics, namely MERS (Middle Eastern respiratory syndrome) and SARS (severe acute respiratory syndrome). The disease induced by SARS-CoV-2 was labelled as COVID-19 by the International Classification of Diseases (ICD) [9]. Chest radiographs are usually of limited value in the diagnosis of early stages especially in mild disease course; however, the CT findings may be present early even before the onset of the symptoms. Chest radiographs is very helpful in the intermediate to advanced stages of COVID-19 with features of acute respiratory distress syndrome (ARDS) as well as the follow-up [10-11]. This study to determine the COVID-19 disease course and severity using chest X-ray (CXR) scoring system and correlate these with patients' age, sex, and outcome.

Study Type

Observational

Enrollment (Actual)

150

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

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study will include 150 patients with suspected COVID-19 infection with positive RT_PCR, MSCT Chest , laboratory investigation. This sample size would be statistically significant. Each group comprises 50 patient , the radiolographic finding xray will be revising and tabulated in each one of the three group according to a standard scheme.

the finding will be correlated with clinical and laboratory finding . statistic of collected data will be performed as needed .

Description

Inclusion Criteria:

  • All individuals attending the Radiodiagnosis Department , who had paired posterior-anterior chest radiographs and RT-PCR nasopharyngeal swabs for COVID-19 at the time of initial attendance with moderate to advanced stage.
  • The patients have positive finding in the posterior-anterior chest radiographs , multislice computer tomography and RT-PCR nasopharyngeal swabs for COVID-19.
  • The patients with positive finding in the laboratory investigation (CBC, CRP ,ESR , S.Ferritin & D-Dimmer) .
  • Patients with positive chest-CT finding and laboratory finding despite of having negative PCR swab

Exclusion Criteria:

  • Patients exceeding 30 days after positive RT-PCR .
  • Patients diagnosed with mediastinal lymphadenopathy , masses ,Tree in bud appearance ,Pneumothorax. Or Cavitation.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mild illness
individuals who have any of the various signs and symptoms of covid-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging findings .
Radiation: chest X-ray
Chest Xray : postero-anterior view ,digital high resolution X-ray or ,full inspiratory
Moderate illness
individuals who show evidence of lower respiratory tract disease during clinical assessment or imaging and who have an oxygen saturation (SpO2) ≥94% on room air .
Radiation: chest X-ray
Chest Xray : postero-anterior view ,digital high resolution X-ray or ,full inspiratory
Severe illness
individuals who have spO2<94% on room air, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2)<300 mm hg, respiratory frequency>30 breaths/min, or lung infiltrate >50%.
Radiation: chest X-ray
Chest Xray : postero-anterior view ,digital high resolution X-ray or ,full inspiratory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity and specificity of initial CXR, where it is reported as having classic COVID-19 features in different clinical severity presentation correlation of xray finding with clinical and laboratory finding.
Time Frame: baseline
to identify the accuracy of chest x-ray in diagnosis of classical covid19 according to the severity of the clinical presentation and laboratory finding
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Nagham Nabil Mahmoud, Professor, Radiodiagnosis Department - Faculty of Medicine - Assiut University
  • Study Director: Hosameldeen Abozaid Yousef, Associate Professor, Radiodiagnosis Department - Faculty of Medicine - Assiut University
  • Study Director: Aliaa Abd-Raboh Mohamed, Professor, Department of Chest Diseases Faculty of Medicine - Assiut University
  • Principal Investigator: Mohamed abdelwahab Ibrahim, bachelor, Radiodiagnosis Resident, Assiut Chest Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

January 31, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • x-ray in covid19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

This sample size would be statistically significant. Each group comprises 50 patient , the radiolographic finding xray will be revising and tabulated in each one of the three group according to a standard scheme.

the finding will be correlated with clinical and laboratory finding . statistic of collected data will be performed as needed .

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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