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NCT05224622 Clinical Trial

Detection of COVID-19 Using Breath Analysis - Validation Study.

COVID-19 Clinical Trial

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 NCT05224622
Other study ID # COV-2-PMC-2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 18, 2022
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 the investigator to distinguish between COVID-19 carriers and COVID-19 non-carriers in comparison to the gold-standard testing methodology.

Recruitment information / eligibility
Status Completed
Enrollment 192
Est. completion date January 18, 2023
Est. primary completion date May 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• VOX
Breath exhalation into the mouthpiece of the VOX breath diagnostic device.

Locations
Country Name City State
Israel Poriya Medical Center Poriyya

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. Obtain early verification accuracy of measures for a set of VOCs biomarkers indicating carriers of Corona virus. 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.
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