Coronavirus Disease 2019NCT05216471
Identify Coronavirus Disease by Chest X-ray
An observational study of Coronavirus Disease 2019, run by Assiut University at 1 site in Egypt.
Trial summary
to identify the diagnostic accuracy of chest X-ray in diagnosis of Coronavirus disease19 . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease 2019
- What is being tested?
- chest X-ray
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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 .
Who may be able to join
- 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
Who cannot join
- Patients exceeding 30 days after positive RT-PCR .
- Patients diagnosed with mediastinal lymphadenopathy , masses ,Tree in bud appearance ,Pneumothorax. Or Cavitation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Chest X-ray in Coronavirus Disease 2019
to identify the diagnostic accuracy of chest X-ray in diagnosis of Coronavirus disease19 .
Read the 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.
- Conditions
- Coronavirus Disease 2019
- Being tested
- chest X-ray
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest X-rayRadiation
Chest Xray : postero-anterior view ,digital high resolution X-ray or ,full inspiratory
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Radiation: chest X-ray | |
| 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 . Receives: Radiation: chest X-ray | |
| 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%. Receives: Radiation: chest X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 May 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease 2019Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelwahab Elsadek Ibrahim, Assiut University
- Investigators
- Nagham Nabil Mahmoud, Professor, Study chair, Radiodiagnosis Department - Faculty of Medicine - Assiut UniversityHosameldeen Abozaid Yousef, Associate Professor, Study director, Radiodiagnosis Department - Faculty of Medicine - Assiut UniversityAliaa Abd-Raboh Mohamed, Professor, Study director, Department of Chest Diseases Faculty of Medicine - Assiut UniversityMohamed abdelwahab Ibrahim, bachelor, Principal investigator, Radiodiagnosis Resident, Assiut Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216471
- Sponsor's protocol ID
- x-ray in covid19
- Status last verified
- Jan 2022
- First submitted
- 27 Jan 2022
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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 .
Publications
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.
PubMed 32007143Custro 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.
PubMed 2000180Litmanovich 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.
PubMed 32520846Cheng 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.
PubMed 17934078Wang 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.
PubMed 32031570
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Chest X-ray in Coronavirus Disease 2019
- ClinicalTrials.gov ID
- NCT05216471
- Acronym / sponsor ID
- x-ray in covid19
- Conditions
- Coronavirus Disease 2019
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild illness | – | Radiation: chest X-rayindividuals 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 | – | Radiation: chest X-rayindividuals who show evidence of lower respiratory tract disease during clinical assessment or imaging and who have an oxygen saturation (SpO2) ≥94% on room air . |
| Severe illness | – | Radiation: chest X-rayindividuals 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%. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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 .
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients exceeding 30 days after positive RT-PCR .
- Patients diagnosed with mediastinal lymphadenopathy , masses ,Tree in bud appearance ,Pneumothorax. Or Cavitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chest X-rayChest Xray : postero-anterior view ,digital high resolution X-ray or ,full inspiratory | Radiation | Mild illness, Moderate illness, Severe illness |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Background: PubMed 32007143Chen 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.
- Background: PubMed 2000180Custro 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.
- Background: PubMed 32520846Litmanovich 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.
- Background: PubMed 17934078Cheng 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.
- Background: PubMed 32031570Wang 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.
- Individual participant dataSharing planned: Undecided. 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 .
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagham Nabil Mahmoud, Professor study chair
Radiodiagnosis Department - Faculty of Medicine - Assiut University
Hosameldeen Abozaid Yousef, Associate Professor study director
Radiodiagnosis Department - Faculty of Medicine - Assiut University
Aliaa Abd-Raboh Mohamed, Professor study director
Department of Chest Diseases Faculty of Medicine - Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Disease 2019, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05216471, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.