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

Scentech Medical Technologies Ltd1 site in 1 country192 target enrollmentJanuary 18, 2022

ConditionsCOVID-19

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: COVID-19
Sponsor: Scentech Medical Technologies Ltd
Enrollment: 192
Locations: 1
Primary Endpoint: Presence of Volatile Organic Compounds indicating carriers of COVID-19.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 18, 2022

End Date

January 18, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Scentech Medical Technologies Ltd

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Presence of Volatile Organic Compounds indicating carriers of COVID-19.

Time Frame: 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 Outcomes

Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.)(Through the study completion, up to 3 months.)