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

NCT ID: NCT05224622

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2023-01-18

Brief Summary

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Detection of the 2019 novel Coronavirus (SARS-CoV-2) using breath analysis - Validation study.

Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Drive In

Drive In attendees will undergo one breath sampling.

Group Type EXPERIMENTAL

VOX

Intervention Type DIAGNOSTIC_TEST

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

Healthy

Healthy attendees will undergo two successive breath sampling.

Group Type EXPERIMENTAL

VOX

Intervention Type DIAGNOSTIC_TEST

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

Corona Department

Healthy attendees will undergo five successive breath sampling.

Group Type EXPERIMENTAL

VOX

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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VOX

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Scentech Medical Technologies Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Avi Peretz, PhD

Role: PRINCIPAL_INVESTIGATOR

Poriya Medical Center

Locations

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Poriya Medical Center

Poria – Neve Oved, , Israel

Site Status

Countries

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Israel

Other Identifiers

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COV-2-PMC-2021

Identifier Type: -

Identifier Source: org_study_id

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