COVID-19
Conditions
Brief summary
Detection of the 2019 novel Coronavirus (SARS-CoV-2) using breath analysis - Validation study.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTVOX
Breath exhalation into the mouthpiece of the VOX breath diagnostic device.
Sponsors
Scentech Medical Technologies Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Volatile Organic Compounds indicating carriers of COVID-19. | Through the study completion, up to 3 months. | Obtain early verification accuracy of measures for a set of VOCs biomarkers indicating carriers of Corona virus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.) | Through the study completion, up to 3 months. | Correlation level between exhaled biomarkers and participants' demographic characteristics. |
Countries
Israel
Outcome results
None listed