Identify Coronavirus Disease by Chest X-ray

• Conditions: Coronavirus Disease 2019
• Interventions: Radiation: chest X-ray

• Registration Number: NCT05216471
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Study Start: 2021-05-01
• Status Verified: 2022-01
• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-01-27
• Last Update Submitted: 2022-01-27
• Study First Posted: 2022-01-31
• Last Update Posted: 2022-01-31
• Primary Completion: 2022-04-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe illness	chest X-ray	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%.
Mild illness	chest X-ray	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 .
Moderate illness	chest X-ray	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 .

Primary Outcome Measures

Name	Time	Method
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.	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

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt