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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-08-01

Brief Summary

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

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm A

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

Group Type EXPERIMENTAL

BioStation T101 and TeraTube

Intervention Type DEVICE

Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.

Arm B

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

Group Type EXPERIMENTAL

BioStation T101 and TeraTube

Intervention Type DEVICE

Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.

Interventions

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BioStation T101 and TeraTube

Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.

Intervention Type DEVICE

Eligibility Criteria

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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.