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

Not Applicable

• Conditions: COVID-19
• Interventions: Device: BioStation T101 and TeraTube

• Registration Number: NCT05162495
• Lead Sponsor: Tera Group

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-12
• Study First Submitted QC: 2021-12-12
• Study First Posted: 2021-12-17
• Last Update Submitted: 2021-12-20
• Study Start: 2022-01-01
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-06-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

General:

1. Male or female subject aged 18 years and above

2. Subject is able and willing to provide informed consent

3. Subject is able to complete the breath test.

   Arm A:

4. Requiring a diagnostic or screening RT-PCR test for COVID-19.

   Arm B:

5. Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening.

Exclusion Criteria

1. Male of female subject under the age of 18.
2. Subject is unable to provide and informed consent, for any reason.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	BioStation T101 and TeraTube	Requiring a diagnostic or screening RT-PCR test for COVID-19.
Arm B	BioStation T101 and TeraTube	Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening.

Primary Outcome Measures

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