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

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Diagnostic Test: VOX

• 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.

Study Timeline

• Study Start: 2022-01-18
• Status Verified: 2022-02
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-04
• Primary Completion: 2022-05-28
• Study Completion: 2023-01-18
• Last Update Submitted: 2023-05-28
• Last Update Posted: 2023-05-31

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

Arm && Interventions

Group	Intervention	Description
Corona Department	VOX	Healthy attendees will undergo five successive breath sampling.
Drive In	VOX	Drive In attendees will undergo one breath sampling.
Healthy	VOX	Healthy attendees will undergo two successive breath sampling.

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