Detection of COVID-19 Using Breath Analysis - Validation Study

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Diagnostic Test: Breath Biopsy Analysis

• Registration Number: NCT04602949
• 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 us to distinguish between Coronavirus (SARS-CoV-2) carriers and SARS-CoV-2-negative in comparison to the gold-standard testing methodology.

Study Timeline

• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-23
• Study First Posted: 2020-10-26
• Study Start: 2020-11-12
• Status Verified: 2022-02
• Primary Completion: 2022-05-28
• Study Completion: 2023-01-18
• Last Update Submitted: 2023-05-14
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2558

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COVID-19 patients	Breath Biopsy Analysis	subjects who were found as COVID-19 positive patients by swab RT-PCR
Healthy controls	Breath Biopsy Analysis	subjects who were found as COVID-19 Negative, by swab RT-PCR

Primary Outcome Measures

Name	Time	Method
Presence of Volatile Organic Compounds indicating carriers of COVID-19.	Through the study completion, up to 3 months.	Comparison of Volatile Organic Compounds found among COVID-19 carriers and Healthy controls.

Secondary Outcome Measures

Name	Time	Method
sensitivity level of biomarkers' algorithm.	Through the study completion, up to 3 months.	comparison of algorithm's sensitivity level to the sensitivity of COVID-19 swab TEST.
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)

Shamir Medical Center; 🇮🇱 Be'er Ya'aqov, Israel