Covid19NCT04615208
Screening for COVID-19
An observational study of Covid19, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- suspected of COVID-19 infection
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 19 Dec 2020to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults suspected of COVID-19 infection
Who may be able to join
- Adults being tested for COVID-19 by swab fluid test
- Must have a smart phone and Internet access
Who cannot join
- age<18 years
- cognitively impaired
- having no access to a smart phone or Internet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Touchless Tool to Screen for COVID-19 for Reopening Industries
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.
Read the detailed description
The goal of this project is to develop a digital technology including an interactive app on a dedicated smartphones to record, analyze and classify a person as likely COVID-19 positive or negative. The specific objectives are:
- Develop an initial simple app to record breathing sounds, check the quality of sounds in real time, message and instruct if the sounds fail the quality check.
- Recruit and collect breathing sounds of at least up to 200 individuals at one of the COVID-19 testing stations in Winnipeg.
- Using data of 50 COVID-19 positive cases and 50 negative ones of the above collection as the training data, develop a breathing sounds analysis algorithm with high sensitivity and specificity for smartphones to classify the recorded breathings sounds as healthy or abnormal. Our current database allows for immediate detection of some underlying unrelated pathologies, which in the initial stages will be supported by the included questionnaire. This can be further enhanced at the end-product stage as each worker's history is built up and daily compared.
- Develop a smart diagnostic algorithm for smartphones as an app using the above sound analysis outcome, the subject's temperature and answers to a few questions and screen for possibility of having Covid-19 in less than 30 seconds.
- Evaluate the above diagnostic algorithm for the remaining collected data (100 subjects), and plan for the next phase of study as a triage in one of the city's hospitals.
- Prepare the final market prototype of the technology and disseminate the results.
- Conditions
- Covid19
- Being tested
- suspected of COVID-19 infection
- Keywords
- Covid19, screnning, touches
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suspected of COVID-19 infectionDiagnostic test
suspected of COVID-19 infection
What is being measured
The primary outcome is the main question the study is designed to answer.
being positive or negative on COVID-19 swab fluid test
Swab Fluid Test
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start19 Dec 2020
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Why it stopped: due to complete lack of cooperation from Winnipeg Health authorities we were not able to recruit and enrolled any participant. We needed to recruit from visitors to testing stations and we were never allowed to do that.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, ID Fusion Software, Inc., Function Four Ltd.
- Responsible party
- Sponsor
- Investigators
- Zahra Moussavi, Ph.D., Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615208
- Sponsor's protocol ID
- B2020:070 (HS24165)
- Status last verified
- Feb 2021
- First submitted
- 2 Nov 2020
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon Ethics approval, we would like to share our recorded breathing sounds with public.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Touchless Tool to Screen for COVID-19 for Reopening Industries
- ClinicalTrials.gov ID
- NCT04615208
- Acronym / sponsor ID
- B2020:070 (HS24165)
- Conditions
- Covid19
- Keywords
- Covid19, screnning, touches
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: due to complete lack of cooperation from Winnipeg Health authorities we were not able to recruit and enrolled any participant. We needed to recruit from visitors to testing stations and we were never allowed to do that.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, ID Fusion Software, Inc., Function Four Ltd.
- Study start
- 19 Dec 2020 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this project is to develop a digital technology including an interactive app on a dedicated smartphones to record, analyze and classify a person as likely COVID-19 positive or negative. The specific objectives are:
- Develop an initial simple app to record breathing sounds, check the quality of sounds in real time, message and instruct if the sounds fail the quality check.
- Recruit and collect breathing sounds of at least up to 200 individuals at one of the COVID-19 testing stations in Winnipeg.
- Using data of 50 COVID-19 positive cases and 50 negative ones of the above collection as the training data, develop a breathing sounds analysis algorithm with high sensitivity and specificity for smartphones to classify the recorded breathings sounds as healthy or abnormal. Our current database allows for immediate detection of some underlying unrelated pathologies, which in the initial stages will be supported by the included questionnaire. This can be further enhanced at the end-product stage as each worker's history is built up and daily compared.
- Develop a smart diagnostic algorithm for smartphones as an app using the above sound analysis outcome, the subject's temperature and answers to a few questions and screen for possibility of having Covid-19 in less than 30 seconds.
- Evaluate the above diagnostic algorithm for the remaining collected data (100 subjects), and plan for the next phase of study as a triage in one of the city's hospitals.
- Prepare the final market prototype of the technology and disseminate the results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults suspected of COVID-19 infection
Key inclusion criteria (2 listed)
- Adults being tested for COVID-19 by swab fluid test
- Must have a smart phone and Internet access
Key exclusion criteria (3 listed)
- age<18 years
- cognitively impaired
- having no access to a smart phone or Internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suspected of COVID-19 infectionsuspected of COVID-19 infection | Diagnostic test | – |
Primary outcome
being positive or negative on COVID-19 swab fluid test
Time frame: one week
Swab Fluid Test
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: Undecided. Upon Ethics approval, we would like to share our recorded breathing sounds with public.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahra Moussavi, Ph.D. principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
being positive or negative on COVID-19 swab fluid test (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.