Identify Coronavirus Disease by Chest X-ray

Coronavirus Disease 2019 Clinical Trial

Official title:

Diagnostic Accuracy of Chest X-ray in Coronavirus Disease 2019

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05216471
• Other study ID #: x-ray in covid19
• Status: Active, not recruiting
• Start date: May 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 1, 2023
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Disease 2019
• Coronavirus Infections
• COVID-19

Intervention

Radiation:
• chest X-ray
Chest Xray : postero-anterior view ,digital high resolution X-ray or ,full inspiratory

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30. — View Citation

Cheng VC, Lau SK, Woo PC, Yuen KY. Severe acute respiratory syndrome coronavirus as an agent of emerging and reemerging infection. Clin Microbiol Rev. 2007 Oct;20(4):660-94. Review. — View Citation

Custro N, Scafidi V, Borsellino T. [Changes in the thyroid hormone picture that may be found in severely decompensated type II diabetics]. Minerva Med. 1991 Jan-Feb;82(1-2):9-14. Italian. — View Citation

Litmanovich DE, Chung M, Kirkbride RR, Kicska G, Kanne JP. Review of Chest Radiograph Findings of COVID-19 Pneumonia and Suggested Reporting Language. J Thorac Imaging. 2020 Nov 1;35(6):354-360. doi: 10.1097/RTI.0000000000000541. Review. — View Citation

Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum in: JAMA. 2021 Mar 16;325(11):1113. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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