Recruiting

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

Sponsor:

McMaster University

Code:

NCT04867213

Conditions

SARS-CoV-2 Infection

Covid19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

SARS-CoV-2 Infection

Covid19

Study ID

NCT04867213

Start date

Feb 15, 2021

Status verified date

Apr, 2021

Completion date

Mar 31, 2022

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria for Covid-19 positive patients:

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.

Inclusion criteria for Covid-19 negative patients:

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 for Covid-19 positive and negative patients:

- Unable to provide a breath sample

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

SARS-CoV-2 Negative

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

Primary outcome measure

Breath VOCs in covid positive and negative patients. [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Gail Gauvreau, PhD

9055259140 gauvreau@mcmaster.ca

Locations

Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8L 0A4

Contacts

Mylinh Duong, MD

905 525-9140 duongmy@mcmaster.ca

Principal Investigator:

Mylinh Duong, MD

More Information

Sponsor

McMaster University

Last update posted

Apr 30, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by McMaster University on 2021-04-30.