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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04867213

Acronym

BREATH

Enrollment

200

Registered

2021-04-30

Start date

2021-02-15

Completion date

2022-03-31

Last updated

2021-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, SARS-CoV-2 Infection

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Breath VOCs in covid positive and negative patients.	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.

Secondary

Measure	Time frame	Description
Effect of time of symptom onset on VOCs in Covid-19 positive patients	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.

Countries

Canada

Contacts

Primary ContactGail Gauvreau, PhD

gauvreau@mcmaster.ca9055259140

Outcome results