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

April 28, 2021 updated by: MyLinh Duong, McMaster University
To analyze Volatile Organic Compounds (VOCs) in the breath of patients with SARS-CoV-2 and controls in SARS-CoV-2 breath specimens.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 0A4
        • Recruiting
        • Hamilton Health Sciences
        • Principal Investigator:
          • Mylinh Duong, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breath VOCs in covid positive and negative patients.
Time Frame: Through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of time of symptom onset on VOCs in Covid-19 positive patients
Time Frame: Through study completion, an average of 1 year
To examine the effect of time of symptom onset on VOCs in the breath of Covid-19 positive patients. 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.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Picomole Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

April 24, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12815

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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