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CompletedNCT04382469Updated May 12, 2020

Egyptian Initial Experience About 2019 Novel Corona Virus: Study of 48 Patients in Alexandria-Egypt Using Chest CT

An observational study in COVID, sponsored by Alexandria University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2020-05-12.

Sponsored by Alexandria University · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Retrospective
Enrollment
48
Sex
All
01

Study 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 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
  1. 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.
  2. 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)
  3. 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.
  4. 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.
  5. Statistical analysis:

Prevalence of clinico-laboratory data and HRCT findings estimated as the percentage of patients showing each criteria or abnormality.

02

Conditions studied

  • COVID
03

In context

Coronavirus Infections

929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.

This study's enrollment of 48 is below the median of 300 across 334 observational studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

Alexandria University is the lead sponsor of 570 studies on the registry; 126 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Probability sample

Study population

Primary care centers

Inclusion criteria

  • Positive COVID-19

Exclusion criteria

Exclusion Criteria:

  • Incomplete medical records, degrade CT images because of patient tachypnea and motions artifacts, also unremarkable CT scans.
05

Study design

Observational model
Case-crossover
Time perspective
Retrospective
Enrollment
48 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Radiological pattern of initial presentation, disease progress, healing and recovery

    HRCT findings

    Time frame: "through study completion, an average of 1 month"

  2. Survey of co-morbid lung diseases

    prevalence

    Time frame: "through study completion, an average of 1 month"

07

Study locations

1 site
  • Faculty of Medicine, University of Alexandria
    Alexandria, 21526, Egypt
08

References and documents

Individual participant data

Plan to share: No — The investigators will recommend further large group future researches for some notices in the study, but preferably not be biased

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04382469
Lead sponsor
Alexandria University
Responsible party
Ahmed Samir (Lecturer of radio-diagnosis, Alexandria University) — Principal investigator
First posted
May 11, 2020
Start date
Feb 1, 2020
Primary completion
Apr 30, 2020
Completion
May 1, 2020
Last update
May 12, 2020

Study contacts

Ahmed Samir, MD
principal investigator · Department of Radio-diagnosis.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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