COVID-19MSCTNCT05235373
Prognostic Significance of COVID-19 MSCT Chest Findings on Short Term Disease Progression
An observational study of COVID-19 and Infection Viral, run by Benha University at 1 site in Egypt.
Trial summary
Background: CT has been used on a massive scale to help identify and investigate suspected or confirmed cases of COVID-19 pneumonia. This study aimed to assess the prognostic significance of the chest findings MSCT of Covid-19 patients and to determine if prognosis can rely on the initial CT imaging. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- COVID-19, Infection Viral
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 15 Oct 2021
- 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 20 to 90 years
- All sexes
- Adult, Older adult
Study population: presented to the chest outpatient clinics in Benha university hospitals and Elabbasyia chest hospital with clinical picture suggestive of COVID 19 infection during the period from April 2020 to December 2020.
Inclusion Criteria:• Patients who had positive RT-PCR test for COVID-19 infection and show positive chest CT findings.
-
Exclusion Criteria:• Patients with negative RT PCR test for COVID 19 infection.
- Patients with positive RT PCR test for COVID 19 and negative chest CT findings.
- Patients with other pre-existing lung pathologies in the chest CT.
Trial locations and contacts
1 site in 1 country.
About this study
Background: CT has been used on a massive scale to help identify and investigate suspected or confirmed cases of COVID-19 pneumonia. This study aimed to assess the prognostic significance of the chest findings MSCT of Covid-19 patients and to determine if prognosis can rely on the initial CT imaging. Methods: The study design was retrospective cohort study. It was carried out on 300 patients presented to the chest outpatient clinics in Benha university hospitals and Elabbasyia chest hospital with clinical picture suggestive of COVID 19 infection. The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive. According to the progression of the respiratory symptoms (include; dyspnea, respiratory rate and O2 saturation), the short-term clinical outcome of the patients was classified into 4 groups; Group A: (mild cases), Group B: (moderate cases), Group C: (sever cases), and Group D: (fatality cases).
Read the detailed description
Patients and methods The study design was retrospective cohort study. It was carried out on 300 patients presented to the chest outpatient clinics in Benha university hospitals and Elabbasyia chest hospital with clinical picture suggestive of COVID 19 infection during the period from April 2020 to December 2020.
Inclusion criteria:
- Patients who had positive RT-PCR test for COVID-19 infection and show positive chest CT findings.
Exclusion criteria:
- Patients with negative RT PCR test for COVID 19 infection.
- Patients with positive RT PCR test for COVID 19 and negative chest CT findings.
- Patients with other pre-existing lung pathologies in the chest CT.
Data were collected from patients files included; history including symptoms and co-morbidities , and previously available examination data.
Approval was taken from the ethics committee of researchers of Benha university. An informed consent was taken from all the participants.
The consent contains:
- Their approval that their studies and clinical data could be used for research purpose.
- All patients' clinical data is considered confidential.
- Signatures or fingerprints of the participants were taken. The picture archiving and communication systems (PACS) in both hospitals were revised during the period form the 1st of April 2020 to the 31st of December 2020. The included CT studies were revised first for technical appropriateness, and the studies with technical problems were excluded.
All chest CT examinations were performed using multislice CT equipment (Toshiba Activion 16 and Toshiba Alexion 16). The exams were performed with patients in supine position and breath-hold during full expiration. The scanning range was from the lower neck down to the level of the adrenal glands. The scanning parameters were as follows: helical scanning mode; tube voltage, 120 kV; tube current-time product, 50-350 mAs; pitch, 1.2 and 1.375; matrix, 512 × 512; slice thickness, 5 mm; reconstructed in distribution lung window; reconstructed slice thickness, 1.25 mm. Followed by sagittal and coronal reconstruction.
The technically accepted studies were extracted from the PACS system. They were interpreted by radiologists and pulmonologist (14 and 10 years in chest CT interpretation respectively) in blind manner.
The following CT features were assessed: (peripheral, central, or central and peripheral), number of lobes involved (one, two or three, four or five), shape (patchy, nodular), appearance (ground-glass opacity [GGO], consolidation, or GGO with consolidation), specific signs within the lesions (vascular thickening, crazy paving pattern, air bronchogram sign, halo sign, and fibrosis), size of largest lesion (< 1 cm, 1-3 cm, > 3 cm), and extra-pulmonary manifestations (mediastinal and hilar lymph node enlargement, pleural effusion, pleural thickening). CT severity scoring was calculated for each case (2).
The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive. According to the progression of the respiratory symptoms (dyspnea, respiratory rate and O2 saturation), the short-term clinical outcome of patients was classified into 4 groups, as follows:
- Group A: (mild cases): with no progression of the respiratory symptoms.
- Group B: (moderate cases): who have worsened disease but not requiring ICU admission.
- Group C: (sever cases): patient who needed ICU admission.
- Group D: (fatality cases): cases who died with or without ICU admission). Statistical Analysis Data were collected, revised, coded and entered to the Statistical Package for Social Science (IBM SPSS) version 20. The qualitative data were presented as number and percentages while quantitative data were presented as mean, standard deviations and ranges when their distribution found parametric. The comparison between two groups with qualitative data were done by using Chi-square test and/or Fisher exact test which was used instead of Chi-square test when the expected count in any cell was found less than 5. The comparison between more than two independent groups with quantitative data and parametric distribution was done by using One Way ANOVA Test. The confidence interval was set to 95% and the margin of error accepted was set to 5%. So, the p-value was considered significant as the following: P> 0.05 = non-significant (NS), P < 0.05 = significant (S), P < 0.001 = highly significant (HS)
- Conditions
- COVID-19, Infection Viral
- Keywords
- COVID-19, MSCT, chest
- Medical subject headings
- COVID-19, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group A: (mild cases): with no progression of the respiratory symptoms. | multislice CT finding,The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive. | |
| group B: (moderate cases): who have worsened disease but not requiring ICU admission. | multislice CT finding,The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive. | |
| Group C: (sever cases): patient who needed ICU admission. | multislice CT finding,The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive. | |
| Group D: (fatality cases): cases who died with or without ICU admission). | multislice CT finding,The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive. |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between initial CT findings with short term clinical outcome
The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive; respiratory symptoms (dyspnea, respiratory rate and O2 saturation),
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Apr 2020
- Primary completion30 Dec 2020
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Benha 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMIRA HUSSEIN ALLAM, Benha University
- Investigators
- AMIRA HM Allam, MD, Principal investigator, chest department, Faculty of medicine, Benha University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235373
- Sponsor's protocol ID
- TEJB-D-22-00019
- Acronym
- MSCT
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance of COVID-19 MSCT Chest Findings on Short Term Disease Progression
- ClinicalTrials.gov ID
- NCT05235373
- Acronym / sponsor ID
- MSCT / TEJB-D-22-00019
- Conditions
- COVID-19, Infection Viral
- Keywords
- COVID-19, MSCT, chest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 11 Feb 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.
Background: CT has been used on a massive scale to help identify and investigate suspected or confirmed cases of COVID-19 pneumonia. This study aimed to assess the prognostic significance of the chest findings MSCT of Covid-19 patients and to determine if prognosis can rely on the initial CT imaging. Methods: The study design was retrospective cohort study. It was carried out on 300 patients presented to the chest outpatient clinics in Benha university hospitals and Elabbasyia chest hospital with clinical picture suggestive of COVID 19 infection. The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive. According to the progression of the respiratory symptoms (include; dyspnea, respiratory rate and O2 saturation), the short-term clinical outcome of the patients was classified into 4 groups; Group A: (mild cases), Group B: (moderate cases), Group C: (sever cases), and Group D: (fatality cases).
Detailed description
Patients and methods The study design was retrospective cohort study. It was carried out on 300 patients presented to the chest outpatient clinics in Benha university hospitals and Elabbasyia chest hospital with clinical picture suggestive of COVID 19 infection during the period from April 2020 to December 2020.
Inclusion criteria:
- Patients who had positive RT-PCR test for COVID-19 infection and show positive chest CT findings.
Exclusion criteria:
- Patients with negative RT PCR test for COVID 19 infection.
- Patients with positive RT PCR test for COVID 19 and negative chest CT findings.
- Patients with other pre-existing lung pathologies in the chest CT.
Data were collected from patients files included; history including symptoms and co-morbidities , and previously available examination data.
Approval was taken from the ethics committee of researchers of Benha university. An informed consent was taken from all the participants.
The consent contains:
- Their approval that their studies and clinical data could be used for research purpose.
- All patients' clinical data is considered confidential.
- Signatures or fingerprints of the participants were taken. The picture archiving and communication systems (PACS) in both hospitals were revised during the period form the 1st of April 2020 to the 31st of December 2020. The included CT studies were revised first for technical appropriateness, and the studies with technical problems were excluded.
All chest CT examinations were performed using multislice CT equipment (Toshiba Activion 16 and Toshiba Alexion 16). The exams were performed with patients in supine position and breath-hold during full expiration. The scanning range was from the lower neck down to the level of the adrenal glands. The scanning parameters were as follows: helical scanning mode; tube voltage, 120 kV; tube current-time product, 50-350 mAs; pitch, 1.2 and 1.375; matrix, 512 × 512; slice thickness, 5 mm; reconstructed in distribution lung window; reconstructed slice thickness, 1.25 mm. Followed by sagittal and coronal reconstruction.
The technically accepted studies were extracted from the PACS system. They were interpreted by radiologists and pulmonologist (14 and 10 years in chest CT interpretation respectively) in blind manner.
The following CT features were assessed: (peripheral, central, or central and peripheral), number of lobes involved (one, two or three, four or five), shape (patchy, nodular), appearance (ground-glass opacity [GGO], consolidation, or GGO with consolidation), specific signs within the lesions (vascular thickening, crazy paving pattern, air bronchogram sign, halo sign, and fibrosis), size of largest lesion (< 1 cm, 1-3 cm, > 3 cm), and extra-pulmonary manifestations (mediastinal and hilar lymph node enlargement, pleural effusion, pleural thickening). CT severity scoring was calculated for each case (2).
The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive. According to the progression of the respiratory symptoms (dyspnea, respiratory rate and O2 saturation), the short-term clinical outcome of patients was classified into 4 groups, as follows:
- Group A: (mild cases): with no progression of the respiratory symptoms.
- Group B: (moderate cases): who have worsened disease but not requiring ICU admission.
- Group C: (sever cases): patient who needed ICU admission.
- Group D: (fatality cases): cases who died with or without ICU admission). Statistical Analysis Data were collected, revised, coded and entered to the Statistical Package for Social Science (IBM SPSS) version 20. The qualitative data were presented as number and percentages while quantitative data were presented as mean, standard deviations and ranges when their distribution found parametric. The comparison between two groups with qualitative data were done by using Chi-square test and/or Fisher exact test which was used instead of Chi-square test when the expected count in any cell was found less than 5. The comparison between more than two independent groups with quantitative data and parametric distribution was done by using One Way ANOVA Test. The confidence interval was set to 95% and the margin of error accepted was set to 5%. So, the p-value was considered significant as the following: P> 0.05 = non-significant (NS), P < 0.05 = significant (S), P < 0.001 = highly significant (HS)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group A: (mild cases): with no progression of the respiratory symptoms. | – | –multislice CT finding,The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive. |
| group B: (moderate cases): who have worsened disease but not requiring ICU admission. | – | –multislice CT finding,The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive. |
| Group C: (sever cases): patient who needed ICU admission. | – | –multislice CT finding,The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive. |
| Group D: (fatality cases): cases who died with or without ICU admission). | – | –multislice CT finding,The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- presented to the chest outpatient clinics in Benha university hospitals and Elabbasyia chest hospital with clinical picture suggestive of COVID 19 infection during the period from April 2020 to December 2020.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation between initial CT findings with short term clinical outcome
Time frame: 3 weeks
The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive; respiratory symptoms (dyspnea, respiratory rate and O2 saturation),
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Individual participant dataSharing planned: No
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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.
AMIRA HM Allam, MD principal investigator
chest department, Faculty of medicine, Benha University, Egypt
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 COVID-19 and Infection Viral, run by Benha 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?
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: finished, as of the sponsor's last update on 11 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
correlation between initial CT findings with short term clinical outcome (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2022.