Breath Analysis of Patients Diagnosed With COVID-19 Using Infrared Spectroscopy

NCT ID: NCT04867213

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-15

Study Completion Date

2022-03-31

Brief Summary

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To analyze Volatile Organic Compounds (VOCs) in the breath of patients with SARS-CoV-2 and controls in SARS-CoV-2 breath specimens.

Detailed Description

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The study is a prospective cohort study, which enrol patients presenting to hospital and are tested for SARS-CoV-2. There will be two cohorts, COVID-19 positive and COVID-19 negative, who will have exhaled breath collection and analysis by infrared spectroscopy to characterize the composition of VOCs and identify differences in VOC profiles between the two groups.

Conditions

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SARS-CoV-2 Infection Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SARS-CoV-2 Positive

Clinically tested for SARS-CoV-2 (as completed by standard laboratory testing e.g. RT-PCR) and with a positive result and clinical features in keeping with COVID-19 illness. The investigators aim to collect breath samples within 7 days of symptom onset in 50% of Covid positive patients, with the remaining patients breath samples collected after 7 days of symptoms onset.

No interventions assigned to this group

SARS-CoV-2 Negative

Patients with a negative RT-PCR COVID-19 test and without any clinical features to suggest COVID-19 illness.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Clinically tested for SARS-CoV-2 (as completed by standard laboratory testing e.g. RT-PCR) with a positive result
* Clinical features in keeping with COVID-19 illness.


* Negative RT-PCR COVID-19 test
* Without any clinical features to suggest COVID-19 illness.
* No known or current features of respiratory infection, COPD, asthma, interstitial lung disease, other respiratory inflammatory conditions or lung cancer.
* Able to provide a breath sample (as based on clinical judgement).

Exclusion Criteria

\- Unable to provide a breath sample
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Breathe BioMedical Inc

INDUSTRY

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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MyLinh Duong

Professor Department of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mylinh Duong, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University Hospital

Locations

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Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Gail Gauvreau, PhD

Role: CONTACT

Phone: 9055259140

Email: [email protected]

Facility Contacts

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Mylinh Duong, MD

Role: primary

References

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Cusack RP, Larracy R, Morrell CB, Ranjbar M, Le Roux J, Whetstone CE, Boudreau M, Poitras PF, Srinathan T, Cheng E, Howie K, Obminski C, O'Shea T, Kruisselbrink RJ, Ho T, Scheme E, Graham S, Beydaghyan G, Gavreau GM, Duong M. Machine learning enabled detection of COVID-19 pneumonia using exhaled breath analysis: a proof-of-concept study. J Breath Res. 2024 Mar 13;18(2). doi: 10.1088/1752-7163/ad2b6e.

Reference Type DERIVED
PMID: 38382095 (View on PubMed)

Other Identifiers

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12815

Identifier Type: -

Identifier Source: org_study_id