COVID19 Versus H1N1: Radiological Challenge During Next Influenza Season Rising

June 14, 2020 updated by: Ahmed Samir, Alexandria University

COVID-19 Versus H1N1 Viral Pneumonia: A Retrospective Comparative Study for Spectrum of HRCT Findings Among 130 Patients

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Alexandria, Egypt, 21526
        • Faculty of Medicine, University of Alexandria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

130 patients; 65 patients known with COVID19 (registered during the period from February till May 2020) and 65 patients known with H1N1 (registered during the period from January 2010 till January 2020).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID19 versus H1N1; radiological comparative study
Time Frame: "through study completion, an average of 20 days"
Find HRCT differences between COVID-19 and H1N1
"through study completion, an average of 20 days"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2020

Primary Completion (Actual)

June 12, 2020

Study Completion (Actual)

June 14, 2020

Study Registration Dates

First Submitted

June 14, 2020

First Submitted That Met QC Criteria

June 14, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 14, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • IRB (00012098), SN (0304669)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The investigators will recommend further large group future researches for some notices in the study, but preferably not be biased

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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