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NCT04602949 Clinical Trial

Detection of COVID-19 Using Breath Analysis - Validation Study

Covid19 Clinical Trial

— COVID-19  

Official title:
Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Validation Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04602949
Other study ID # Cov-2-SMC-2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 12, 2020
Est. completion date January 18, 2023

Study information
Verified date February 2022
Source Scentech Medical Technologies Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY

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 information / eligibility
Status Completed
Enrollment 2558
Est. completion date January 18, 2023
Est. primary completion date May 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Breath Biopsy Analysis
Analysis of a single breath Biopsy

Locations
Country Name City State
Israel Shamir Medical Center Be'er Ya'aqov

Sponsors (1)
Lead Sponsor Collaborator
Scentech Medical Technologies Ltd

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of Volatile Organic Compounds indicating carriers of COVID-19. Comparison of Volatile Organic Compounds found among COVID-19 carriers and Healthy controls. Through the study completion, up to 3 months.
Secondary Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.). Correlation level between exhaled biomarkers and participants' demographic characteristics. Through the study completion, up to 3 months.
Secondary sensitivity level of biomarkers' algorithm. comparison of algorithm's sensitivity level to the sensitivity of COVID-19 swab TEST. Through the study completion, up to 3 months.
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