Detection of COVID-19 Using Breath Analysis - Validation Study
Not Applicable
Completed
- Conditions
- Covid19
- Registration Number
- NCT04602949
- Lead Sponsor
- Scentech Medical Technologies Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2558
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Shamir Medical Center
🇮🇱Be'er Ya'aqov, Israel
Shamir Medical Center🇮🇱Be'er Ya'aqov, Israel