Clinical trial NCT05216471: Identify Coronavirus Disease by Chest X-ray
Official title: Diagnostic Accuracy of Chest X-ray in Coronavirus Disease 2019
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Disease 2019
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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 .

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Radiodiagnosis Department - Faculty of Medicine - Assiut University
name: Nagham Nabil Mahmoud, Professor
role: STUDY_CHAIR
affiliation: Radiodiagnosis Department - Faculty of Medicine - Assiut University
name: Hosameldeen Abozaid Yousef, Associate Professor
role: STUDY_DIRECTOR
affiliation: Department of Chest Diseases Faculty of Medicine - Assiut University
name: Aliaa Abd-Raboh Mohamed, Professor
role: STUDY_DIRECTOR
affiliation: Radiodiagnosis Resident, Assiut Chest Hospital
name: Mohamed abdelwahab Ibrahim, bachelor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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. doi: 10.1128/CMR.00023-07.
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.