Early Detection of COVID-19 Using Breath Analysis - Feasibility Study

Study Overview
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Brief Summary
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Early Detection of COVID-19 Using Breath Analysis -Feasibility Study.

Detailed Description
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An interventional diagnostic prospective study study with risks and minimal constraints.

Official Title
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Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Feasibility Study

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: Breath Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized group: Age 18 to 75 years at the time of consent Positive results for SARS-CoV-2 Capable of understanding written and/or spoken language Able to provide informed consent Was not treated with Anti-viral drugs Not a pregnant woman Healthy group: Healthy volunteers Age 18 to 75 years at the time of consent No history of COVID-19 Capable of understanding written and/or spoken language Able to provide informed consent Was not treated with Anti-viral drugs Not a pregnant woman Sexes Eligible for Study: All Exclusion Criteria: Hospitalized group: Age under 18 years old (Anticipated) inability to complete breath sampling procedure due to e.g. hyper- or hypoventilation, respiratory failure or claustrophobia when wearing the sampling mask Persons under guardianship or deprived of liberty Patients with the following diseases: Cancer, Asthma, Chronic Respiratory Disease Healthy group: Age under 18 years old History of COVID-19 Persons under guardianship or deprived of liberty Subjects with the following diseases: Cancer, Asthma, Chronic Respiratory Disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVID 19 Positive patients<br>Patients with COVID-19, qPCR for SARS-CoV-2 confirmed | Diagnostic Test: Breath Biopsy<br>* Breath Biopsy sampling using the ReCIVA® Breath Sampler<br>|
| Other: Healthy subjects<br>COVID-19 Negative subjects | Diagnostic Test: Breath Biopsy<br>* Breath Biopsy sampling using the ReCIVA® Breath Sampler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between Volatile Organic Compounds pattern in-breath biopsy and COVID-19 detection. | Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection in a swab test. | Through the study completion, up to 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between Volatile Organic Compounds pattern and the course of the disease | Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection intensity in a swab test. | Through the study completion, up to 3 months. |