Breath Samples Collection Clinical Trial, for Development of the TERA BioStation T101, Intended for CoV-19 Exhalation Products Detection.

Study Overview
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Brief Summary
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The Sponsor has developed a rapid screening tool intended to determine if the subject tested has COVID-19.

Detailed Description
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According to recent scientific literature, the virus infection occurs mainly through the nasal cavity, and therefore, samples of nasal and pharyngeal fluids are expected to be high viral load samples. The proposed clinical trial is to test the mentioned for potential dominant virus particles absorbance frequencies according to which, it will be possible to perform a statistical analysis of spectral data of infected subjects' samples compared to healthy ones and to examine whether a statistical significance between 'Infected' and 'Healthy' can be demonstrated in terms spectroscopic measurements. Indication for Use: Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples. The study is aimed to collect data in order to assess whether a patient's COVID -19 status can be identified by a unique spectrophotometric pattern.

Official Title
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A Single Center, Two Arms, Non-interventional, Breath Samples Collection Clinical Trial, for Development of the TERA Bio Station T101, Intended for SARS-CoV-2 Exhalation Products Detection.

Conditions
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COVID-19

Intervention / Treatment
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* Device: BioStation T101 and TeraTube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General: Male or female subject aged 18 years and above Subject is able and willing to provide informed consent Subject is able to complete the breath test. Arm A: Requiring a diagnostic or screening RT-PCR test for COVID-19. Arm B: Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening. Exclusion Criteria: Male of female subject under the age of 18. Subject is unable to provide and informed consent, for any reason.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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: Single Group Assignment
Interventional Model Description: The participant's breath sample is taken by blowing preferably three times into a disposable TeraTube. Thereafter, the tube is sealed, sterilized, and scanned by the BioSafety Station for analysis of its bio-chemical spectral signature. This will take place once during the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Requiring a diagnostic or screening RT-PCR test for COVID-19. | Device: BioStation T101 and TeraTube<br>* Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.<br>|
| Experimental: Arm B<br>Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening. | Device: BioStation T101 and TeraTube<br>* Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome Measure | Rate of positive and negative cases in collected breath samples using breath analyzer test compare to PCR results. | The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample |