- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04433039
COVID19 Versus H1N1: Radiological Challenge During Next Influenza Season Rising
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
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Alexandria, Egypt, 21526
- Faculty of Medicine, University of Alexandria
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on COVID
-
European Institute of OncologyFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta; Azienda Ospedaliera... and other collaboratorsCompleted
-
Owlstone LtdCambridge University Hospitals NHS Foundation TrustCompleted
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Sultan Qaboos UniversityCompletedCOVID-19 | Non-CovidOman
-
Assiut UniversityRecruiting
-
Jilin UniversityUnknown
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Miami VA Healthcare SystemNot yet recruiting