COVID19 Versus H1N1: Radiological Challenge During Next Influenza Season Rising

NCT ID: NCT04433039

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-22
• Study Completion Date: 2020-06-14

Brief Summary

Background: Till the moment of editing this paperwork, WHO announced that there is no specific drugs or vaccines for treatment or prophylaxis of COVID-19. Additionally during the global gradual unlocking of community restrictions, WHO warned form another wave of the disease during the next few months. So clinicians and radiologists during this second wave would face great challenges in differentiation between COVID-19 and other virulent influenza viruses, mainly H1N1.

Objective: to establish comparative radiological study between COVID19 and H1N1 to find differentiating criteria that would help during their expected clinico-laboratory and radiological overlap in next Influenza season.

Material and methods: Retrospective study was including 130 patients; 65 COVID-19 patients and 65 H1N1 patients. HRCT findings to be analyzed by three expert consultant radiologists.

Detailed Description

A. Study population and medical records review:

Inclusion criteria: 65 COVID-19 and 65 H1N1 patients to be enrolled. Exclusion criteria: (1) Degraded quality of CT scans due to patient unavoidable tachypnea with respiratory motion artifacts. (2) Unremarkable CT scans were also excluded. (3) Past history of large airway disease, asthma, COPD or bronchiectasis. (4) Patients with secondary bacterial infection.

B. CT scanning and parameters:

CT examinations conducted using multiple MDCT machines including: GE LightSpeed Plus 4 slice CT scanner (USA), Philips Brilliant-16 (USA), Siemens SOMATOM Emotion 16 and Siemens SOMATOM Sensation 64 (Germany), Toshiba Aquilion 64 and Toshiba Aquilion CXL/CX 128 (USA).

CT Scanning parameters : Slice thickness: 1 - 1.25 mm. Volumetric HRCT table speed with 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 the type of MSCT machine used, the weight of the patient and the clinical indication.

C. CT analysis:

CT images to be assessed by three consultant radiologists (having long time experience in chest imaging). Image analysis in axial, sagittal and coronal planes done using both maximum intensity projection (MIP) and minimum intensity projection (Min-IP) reconstructions. The following CT features to be compared between each pathological process:

A. Site of the pathology: unilateral or bilateral - focal, multi-focal or diffuse.

B. Mosaic pattern; including ground glass opacities (GGO), mosaic perfusion, air trapping and "head cheese pattern".

C. Reticular pattern; including interlobular septal thickening, "crazy paving pattern", bronchial wall thickening, mucous plugging, traction bronchiectasis/bronchiolectasis and honeycombing.

D. Nodular pattern; including GG nodules and solid nodules; including solid nodules with "halo sign" and tree in bud nodules.

E. Relevant CT findings: including pleural, pericardial and nodal lesions.

D. Statistical analysis:

The prevalence of HRCT findings estimated as the percentage of patients showing each criteria or abnormality.

Conditions

COVID

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients with COVID-19 or H1N1

Exclusion Criteria

(1) Degraded quality of CT scans due to patient unavoidable tachypnea with respiratory motion artifacts. (2) Unremarkable CT scans were also excluded. (3) Past history of large airway disease, asthma, COPD or bronchiectasis. (4) Patients with secondary bacterial infection.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Samir

Lecturer of radio-diagnosis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Samir, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Radio-diagnosis.

Locations

Faculty of Medicine, University of Alexandria

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

IRB (00012098), SN (0304669)

Identifier Type: -

Identifier Source: org_study_id