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

Scentech Medical Technologies Ltd1 site in 1 country2,558 target enrollmentNovember 12, 2020

ConditionsCovid19

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Covid19
Sponsor: Scentech Medical Technologies Ltd
Enrollment: 2558
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 us to distinguish between Coronavirus (SARS-CoV-2) carriers and SARS-CoV-2-negative in comparison to the gold-standard testing methodology.

Registry

clinicaltrials.gov

Start Date

November 12, 2020

End Date

January 18, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Scentech Medical Technologies Ltd

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: Through the study completion, up to 3 months.

Comparison of Volatile Organic Compounds found among COVID-19 carriers and Healthy controls.

Secondary Outcomes

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