Screening for COVID-19

NCT04615208 | Withdrawn

• 1 other identifier: B2020:070 (HS24165)
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Canada is entering the important yet dangerous phase of the COVID-19 pandemic: the reopening of industry. As such, there is an urgent need for a quick and accurate screening tool to help ensure people re-entering the workplace are COVID-19 negative. This proposal offers an innovative, simple-to-implement and quick screening tool for this purpose. This study hypothesize that breathing sounds of a COVID-19 positive person would have different characteristics even if the person is asymptomatic. This study aim the development of an integrated diagnostic pattern recognition tool in the form of a smartphone app, using audio and temperature as inputs to identify COVID-19 positive individuals. The proposed digital technology will screen individuals as healthy or possibly COVID-19 positive. The latter group will then be recommended for further testing. The goal of the proposed app is to provide much more accurate early screening (currently only temperature is taken), and to reduce the burden of COVID-19 tests. This digital technology will be used and tested in Manitoba initially and later nationally in Canada, with the potential of being publicly available in the future. To use the proposed screening tool, a smartphone is held within 1 cm of an individual's mouth and the individual instructed to take five deep breaths through the mouth. The individuals' breathing sounds will be recorded by the smartphone, while the participant's temperature will also be recorded by the heat camera. The app will first use its acoustic analysis to identify sounds as healthy or abnormal. If the outcome is abnormal, then a questionnaire will be provided, along with a further acoustic analysis to rule out other common comorbid conditions (e.g. chronic lung disease). Finally, based on the inputs, the diagnostic algorithm will decide if the individual should be referred for further testing or not. Since the proposed end product is a smartphone app, the two software partner companies will play a crucial role in the final integration and development.

Conditions

Covid19

Keywords

Covid19; screnning; touches

Outcome Measures

Primary Outcomes (1)

• being positive or negative on COVID-19 swab fluid test

  Swab Fluid Test

  one week

Interventions

suspected of COVID-19 infection DIAGNOSTIC_TEST

suspected of COVID-19 infection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults suspected of COVID-19 infection

You may qualify if:

• Adults being tested for COVID-19 by swab fluid test
• Must have a smart phone and Internet access

You may not qualify if:

• age\<18 years
• cognitively impaired
• having no access to a smart phone or Internet

Sponsors & Collaborators

• University of Manitoba: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator
• ID Fusion Software, Inc.: collaborator
• Function Four Ltd.: collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zahra Moussavi, Ph.D.

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 4, 2020
• Study Start: December 19, 2020
• Primary Completion: October 30, 2021
• Study Completion: December 30, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-02

Locations

CA (1)