COVIDNCT04382469
Egyptian Initial Experience About 2019 Novel Corona Virus: Study of 48 Patients in Alexandria-Egypt Using Chest CT
An observational study of COVID, run by Alexandria University at 1 site in Egypt.
Trial summary
Background: Corona virus disease 2019 (COVID-19) is a highly infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Purpose: To give initial experience about COVID-19 in Alexandria-Egypt describing radiological patterns of lung involvement, also surveying prevalence of co-morbid… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 1 May 2020
- 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
- Child, Adult, Older adult
Study population: Primary care centers
Who may be able to join
- Positive COVID-19
Who cannot join
- Incomplete medical records, degrade CT images because of patient tachypnea and motions artifacts, also unremarkable CT scans.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Egyptian Initial Experience About 2019 Novel Corona Virus Disease (COVID-19): Single-center Study Analysis of 48 Patients in Alexandria-Egypt Regarding Radiological Patterns and Co-morbid Lung Diseases
Background: Corona virus disease 2019 (COVID-19) is a highly infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Purpose: To give initial experience about COVID-19 in Alexandria-Egypt describing radiological patterns of lung involvement, also surveying prevalence of co-morbid lung diseases and their effect on COVID-19 presentation.
Methods: Retrospective study including 48 patients with positive polymerase chain reaction (PCR) test for COVID-19 during the period from February 2020 till May 2020 in Alexandria/Egypt. Full clinical and laboratory data are obtained. High resolution computed tomography (HRCT) findings are described. Serial follow up studies are done. Surveying co-morbid lung diseases done including tuberculosis (TB), interstitial lung diseases (ILDs), chronic obstructive lung disease (COPD), immune and vascular-related diseases. Prevalence rate is the predominant analysis.
Read the detailed description
- Study population and medical records review:
- This retrospective study in Alexandria/Egypt during the period from February 2020 till May 2020, approved by out Institutional Ethics Committee. Patient consent waived by the Research Ethics Board, assuring respect of patient and medical records confidentiality. No overlap with any previously published work.
- Forty-eight Egyptian patients with proved COVID-19 test results to be enrolled in this study without age or sex limitations.
- Complete medical records to be obtained including thorough history taking and clinical examination. This include patient age and sex, smoking history, exposure history (including direct contact to positive COVID-19 patient or recent travelling to high risk countries¬, also health care providers to positive COVID-19 patients).
- Present history to be taken regarding patient chest or general complaint.
- Past history to be acquired regarding general chronic or debilitating diseases and cardio-pulmonary co-morbid diseases including TB, ILDs, COPD, immune and vascular related diseases.
- Thorough general and local chest examination to be carried out.
- Initial lab investigations to be obtained including complete blood count (CBC) and C-reactive protein) CRP. Blood gases and O2 saturation to be also reported.
- Strict protocol of infection control to be followed during clinical assessment, laboratory work and radiological examinations according to the national and the international guidelines.
- Exclusion criteria were: Incomplete medical records, degrade CT images because of patient tachypnea and motions artifacts, also unremarkable CT scans.
- Clinical and laboratory data analysis:
- The clinical and laboratory data to be obtained and analyzed by four consultant pulmonogists and single consultant chest pediatrician (having long time experience in clinical practice of chest infectious diseases and ICU patients for 20 to 33 years)
- CT scanning and parameters:
- CT examinations using multiple MDCT machines including Philips Brilliant-16, Siemens Emotion-64, Toshiba Aquilion-16, Toshiba Aquilion-64 and Toshiba Aquilion CXL/CX 128.
- CT Scanning parameters: Slice thickness: 1 - 1.25 mm. Volumetric HRCT table speed that yields least cycles of breath holds as possible. Tube rotation: 0.6-0.9 second. Detector Collimation 1 mm. Helical mode (volumetric HRCT). kVp and mA per slice: 120 - 130 KVp and 200-400 mA, according to type of MSCT machine used, weight of the patient and clinical indication.
- Positive intra-venous contrast administration only when prescribed.
- CT analysis:
- CT images to be viewed by four consultant radiologists (having long time experience in thoracic imaging ranging from 11 to 25 years) using either specialized work stations or Di-com viewers on personal computers with analysis of the axial, sagittal and coronal planes. MIP and Min-IP reconstructions to be routinely analyzed.
- Statistical analysis:
Prevalence of clinico-laboratory data and HRCT findings estimated as the percentage of patients showing each criteria or abnormality.
- Conditions
- COVID
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological pattern of initial presentation, disease progress, healing and recovery
HRCT findings
Measured: "through study completion, an average of 1 month"
Survey of co-morbid lung diseases
prevalence
Measured: "through study completion, an average of 1 month"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 Feb 2020
- Primary completion30 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samir, Alexandria University
- Investigators
- Ahmed Samir, MD, Principal investigator, Department of Radio-diagnosis.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382469
- Sponsor's protocol ID
- IRB (00012098), FWA (00018699)
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will recommend further large group future researches for some notices in the study, but preferably not be biased
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Egyptian Initial Experience About 2019 Novel Corona Virus Disease (COVID-19): Single-center Study Analysis of 48 Patients in Alexandria-Egypt Regarding Radiological Patterns and Co-morbid Lung Diseases
- ClinicalTrials.gov ID
- NCT04382469
- Acronym / sponsor ID
- IRB (00012098), FWA (00018699)
- Conditions
- COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 11 May 2020 (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: Corona virus disease 2019 (COVID-19) is a highly infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Purpose: To give initial experience about COVID-19 in Alexandria-Egypt describing radiological patterns of lung involvement, also surveying prevalence of co-morbid lung diseases and their effect on COVID-19 presentation.
Methods: Retrospective study including 48 patients with positive polymerase chain reaction (PCR) test for COVID-19 during the period from February 2020 till May 2020 in Alexandria/Egypt. Full clinical and laboratory data are obtained. High resolution computed tomography (HRCT) findings are described. Serial follow up studies are done. Surveying co-morbid lung diseases done including tuberculosis (TB), interstitial lung diseases (ILDs), chronic obstructive lung disease (COPD), immune and vascular-related diseases. Prevalence rate is the predominant analysis.
Detailed description
- Study population and medical records review:
- This retrospective study in Alexandria/Egypt during the period from February 2020 till May 2020, approved by out Institutional Ethics Committee. Patient consent waived by the Research Ethics Board, assuring respect of patient and medical records confidentiality. No overlap with any previously published work.
- Forty-eight Egyptian patients with proved COVID-19 test results to be enrolled in this study without age or sex limitations.
- Complete medical records to be obtained including thorough history taking and clinical examination. This include patient age and sex, smoking history, exposure history (including direct contact to positive COVID-19 patient or recent travelling to high risk countries¬, also health care providers to positive COVID-19 patients).
- Present history to be taken regarding patient chest or general complaint.
- Past history to be acquired regarding general chronic or debilitating diseases and cardio-pulmonary co-morbid diseases including TB, ILDs, COPD, immune and vascular related diseases.
- Thorough general and local chest examination to be carried out.
- Initial lab investigations to be obtained including complete blood count (CBC) and C-reactive protein) CRP. Blood gases and O2 saturation to be also reported.
- Strict protocol of infection control to be followed during clinical assessment, laboratory work and radiological examinations according to the national and the international guidelines.
- Exclusion criteria were: Incomplete medical records, degrade CT images because of patient tachypnea and motions artifacts, also unremarkable CT scans.
- Clinical and laboratory data analysis:
- The clinical and laboratory data to be obtained and analyzed by four consultant pulmonogists and single consultant chest pediatrician (having long time experience in clinical practice of chest infectious diseases and ICU patients for 20 to 33 years)
- CT scanning and parameters:
- CT examinations using multiple MDCT machines including Philips Brilliant-16, Siemens Emotion-64, Toshiba Aquilion-16, Toshiba Aquilion-64 and Toshiba Aquilion CXL/CX 128.
- CT Scanning parameters: Slice thickness: 1 - 1.25 mm. Volumetric HRCT table speed that yields least cycles of breath holds as possible. Tube rotation: 0.6-0.9 second. Detector Collimation 1 mm. Helical mode (volumetric HRCT). kVp and mA per slice: 120 - 130 KVp and 200-400 mA, according to type of MSCT machine used, weight of the patient and clinical indication.
- Positive intra-venous contrast administration only when prescribed.
- CT analysis:
- CT images to be viewed by four consultant radiologists (having long time experience in thoracic imaging ranging from 11 to 25 years) using either specialized work stations or Di-com viewers on personal computers with analysis of the axial, sagittal and coronal planes. MIP and Min-IP reconstructions to be routinely analyzed.
- Statistical analysis:
Prevalence of clinico-laboratory data and HRCT findings estimated as the percentage of patients showing each criteria or abnormality.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care centers
Key inclusion criteria (1 listed)
- Positive COVID-19
Key exclusion criteria (1 listed)
- Incomplete medical records, degrade CT images because of patient tachypnea and motions artifacts, also unremarkable CT scans.
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
Radiological pattern of initial presentation, disease progress, healing and recovery
Time frame: "through study completion, an average of 1 month"
HRCT findings
Survey of co-morbid lung diseases
Time frame: "through study completion, an average of 1 month"
prevalence
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 12 May 2020.
- Individual participant dataSharing planned: No. The investigators will recommend further large group future researches for some notices in the study, but preferably not be biased
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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.
Ahmed Samir, MD principal investigator
Department of Radio-diagnosis.
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, run by Alexandria 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 May 2020. 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?
Radiological pattern of initial presentation, disease progress, healing and recovery (time frame: "through study completion, an average of 1 month"). The study lists 2 primary outcomes in all. 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 12 May 2020.