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

NCT04867213 | Unknown

• 1 other identifier: 12815
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Breath VOCs in covid positive and negative patients.

  To examine Volatile Organic Compounds (VOCs) by infrared spectroscopy in the breath of patients with SARS-CoV-2 and controls to determine if VOCs within a breath sample can differentiate Covid-19 positive from Covid-19 negative patients.

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Effect of time of symptom onset on VOCs in Covid-19 positive patients

  Through study completion, an average of 1 year

Study Arms (2)

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.

Eligibility Criteria

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

Study Population

Hospitalized patients

You may qualify if:

• 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).

You may not qualify if:

• \- Unable to provide a breath sample

Sponsors & Collaborators

• McMaster University: lead
• Breathe BioMedical Inc: collaborator

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8L 0A4, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 38382095 DERIVED

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

• Mylinh Duong, MD

  McMaster University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gail Gauvreau, PhD

CONTACT

9055259140; gauvreau@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Department of Medicine

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: April 30, 2021
• Study Start: February 15, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

CA (1)