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

Primary Purpose

COVID-19

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

VOX

About this trial

This is an interventional diagnostic trial for COVID-19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Poriya Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Drive In

Healthy

Corona Department

Arm Description

Drive In attendees will undergo one breath sampling.

Healthy attendees will undergo two successive breath sampling.

Healthy attendees will undergo five successive breath sampling.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.)

Correlation level between exhaled biomarkers and participants' demographic characteristics.

Full Information

NCT ID

NCT05224622

First Posted

February 3, 2022

Last Updated

May 28, 2023

Sponsor

Scentech Medical Technologies Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05224622

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

January 18, 2022 (Actual)

Primary Completion Date

May 28, 2022 (Actual)

Study Completion Date

January 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Scentech Medical Technologies Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

192 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drive In

Arm Type

Experimental

Arm Description

Drive In attendees will undergo one breath sampling.

Arm Title

Healthy

Arm Type

Experimental

Arm Description

Healthy attendees will undergo two successive breath sampling.

Arm Title

Corona Department

Arm Type

Experimental

Arm Description

Healthy attendees will undergo five successive breath sampling.

Intervention Type

Diagnostic Test

Intervention Name(s)

VOX

Intervention Description

Breath exhalation into the mouthpiece of the VOX breath diagnostic device.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Through the study completion, up to 3 months.

Secondary Outcome Measure Information:

Title

Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.)

Description

Correlation level between exhaled biomarkers and participants' demographic characteristics.

Time Frame

Through the study completion, up to 3 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Avi Peretz, PhD

Organizational Affiliation

Poriya Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Poriya Medical Center

City

Poriyya

ZIP/Postal Code

1528001

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No IPD

Learn more about this trial

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

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