Detection of COVID-19 Using Breath Analysis - Validation Study.
Not Applicable
Completed
- Conditions
- COVID-19
- Registration Number
- NCT05224622
- 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 the investigator to distinguish between COVID-19 carriers and COVID-19 non-carriers in comparison to the gold-standard testing methodology.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Poriya Medical Center
🇮🇱Poriyya, Israel
Poriya Medical Center🇮🇱Poriyya, Israel