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

Covid19 Clinical Trial

— BREATH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04867213
• Other study ID #: 12815
• Status: Recruiting
• Start date: February 15, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2021
• Source: McMaster University
• Contact: Gail Gauvreau, PhD
• Phone: 9055259140
• Email: gauvreau[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• SARS-CoV-2 Infection

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Picomole Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effect of time of symptom onset on VOCs in Covid-19 positive patients	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