Detection of COVID-19 Using Breath Analysis - Validation Study
Study Details
Study Description
Brief Summary
DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: COVID-19 patients subjects who were found as COVID-19 positive patients by swab RT-PCR |
Diagnostic Test: Breath Biopsy Analysis
Analysis of a single breath Biopsy
|
Other: Healthy controls subjects who were found as COVID-19 Negative, by swab RT-PCR |
Diagnostic Test: Breath Biopsy Analysis
Analysis of a single breath Biopsy
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 6 to 75 years at the time of consent
-
Capable of understanding written and/or spoken language
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Able to provide informed consent
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Was not treated with Anti-viral drugs
Exclusion Criteria:
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Age under 6 years old
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Under guardianship or deprived of liberty
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Pregnant or lactating woman
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Shamir Medical Center | Be'er Ya'aqov | Israel |
Sponsors and Collaborators
- Scentech Medical Technologies Ltd
Investigators
- Study Director: Natalie Dror, PhD, Scentech Medical Technologies Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Cov-2-SMC-2020