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

Tera Group

Status: Unknown

Conditions: COVID-19

Treatments: Device: BioStation T101 and TeraTube

Study type: Interventional

Funder types: Industry

Identifiers

NCT05162495

TERA-COV-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Arm A

Experimental group

Description:

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

Treatment:

Device: BioStation T101 and TeraTube

Arm B

Experimental group

Description:

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

Treatment:

Device: BioStation T101 and TeraTube