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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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SARS-CoV-2 Infection, Covid19

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SARS-CoV-2 Positive<br>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<br>Patients with a negative RT-PCR COVID-19 test and without any clinical features to suggest COVID-19 illness. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |