Covid19
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 us to distinguish between Coronavirus (SARS-CoV-2) carriers and SARS-CoV-2-negative in comparison to the gold-standard testing methodology.
Interventions
DIAGNOSTIC_TESTBreath Biopsy Analysis
Analysis of a single breath Biopsy
Sponsors
Scentech Medical Technologies Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 6 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 6 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. | Comparison of Volatile Organic Compounds found among COVID-19 carriers and Healthy controls. |
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. |
| sensitivity level of biomarkers' algorithm. | Through the study completion, up to 3 months. | comparison of algorithm's sensitivity level to the sensitivity of COVID-19 swab TEST. |
Countries
Israel
Outcome results
None listed