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

McMaster University

Status: Unknown

Conditions: SARS-CoV-2 Infection; Covid19

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04867213

12815

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

200 participants in 2 patient groups

SARS-CoV-2 Positive

Description:

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

Description:

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