Early Detection of COVID-19 Using Breath Analysis

Study Overview
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Brief Summary
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EARLY DETECTION OF COVID-19 USING BREATH ANALYSIS- FIRST CROSS-SECTIONAL STUDY

Detailed Description
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Primary objective- to identify and evaluate a set of biomarkers that represent both the genetic expression of the virus itself (SARS-CoV-2) and the metabolic activity of the immune system's response to the virus.

Official Title
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Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis: First Cross-Sectional Study

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 55 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 Exclusion Criteria: 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 Pregnant women Treated with antiviral drugs upon admission or during hospitalization Novices and soldiers in initial training

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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>subjects who were found COVID-19 Positive according to swab test. | Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler<br>* Breath biopsy sampling using the ReCIVA Breath Sampler<br>|
| Other: Healthy subjects<br>subjects who were found COVID-19 Negative according to swab test. | Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler<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 and COVID-19 detection status. | Correlation between the set of Volatile Organic Compounds found in breath biopsy and COVID-19 detection presence 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 time from COVID-19 detection. | Correlation between the set of Volatile Organic Compounds found in breath biopsy and time since COVID-19 detected in a swab test. | Through the study completion, up to 3 months. | 
| Correlation between the set of Volatile Organic Compounds found in breath biopsy and disease intensity. | Correlation between the set of Volatile Organic Compounds found in breath biopsy and intensity of COVID-19 detected in a swab test. | Through the study completion, up to 3 months. |