NCT04433039

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2020

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

21 days

First QC Date

June 14, 2020

Last Update Submit

June 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • COVID19 versus H1N1; radiological comparative study

    Find HRCT differences between COVID-19 and H1N1

    "through study completion, an average of 20 days"

Eligibility Criteria

Age4 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • Patients with COVID-19 or H1N1

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, University of Alexandria

Alexandria, 21526, Egypt

Location

Study Officials

  • Ahmed Samir, MD

    Department of Radio-diagnosis.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of radio-diagnosis

Study Record Dates

First Submitted

June 14, 2020

First Posted

June 16, 2020

Study Start

May 22, 2020

Primary Completion

June 12, 2020

Study Completion

June 14, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

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

Locations