Detection of COVID-19 Using Breath Analysis - Validation Study.

Scentech Medical Technologies Ltd192 enrolled

Overview

Detection of the 2019 novel Coronavirus (SARS-CoV-2) using breath analysis - Validation study.

A diagnostic prospective single-site study, with no anticipated risks or constraints. Primary objective- To validate the value of a set of breath VOC biomarkers that enable the investigator to distinguish between COVID-19 carriers and COVID-19 non-carriers in comparison to the gold-standard testing methodology.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

192

Conditions

COVID-19

Interventions

VOXDIAGNOSTIC_TEST

Breath exhalation into the mouthpiece of the VOX breath diagnostic device.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 to 75 years at the time of consent * Capable of understanding written and/or spoken language * Able to provide informed consent * Was not treated with Anti-viral drugs Exclusion Criteria: * Age under 18 years old * Under guardianship or deprived of liberty * Pregnant or lactating woman

Locations (1)

Poriya Medical Center

Poria – Neve Oved, Israel

Outcomes

Primary Outcomes

Presence of Volatile Organic Compounds indicating carriers of COVID-19.

Obtain early verification accuracy of measures for a set of VOCs biomarkers indicating carriers of Corona virus.

Time frame: Through the study completion, up to 3 months.

Secondary Outcomes

Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.)

Correlation level between exhaled biomarkers and participants' demographic characteristics.

Time frame: Through the study completion, up to 3 months.

Data from ClinicalTrials.gov

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