COVID Clinical Trial
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.
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.
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