Early Detection of COVID-19 Using Breath Analysis

NCT ID: NCT04602884

Last Updated: 2022-02-07

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-22

Study Completion Date

2021-12-30

Brief Summary

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EARLY DETECTION OF COVID-19 USING BREATH ANALYSIS- FIRST CROSS-SECTIONAL STUDY

Detailed Description

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Primary objective- to identify and evaluate a set of biomarkers that represent both the genetic expression of the virus itself (SARS-CoV-2) and the metabolic activity of the immune system's response to the virus.

Conditions

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Covid19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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COVID-19 Positive patients

subjects who were found COVID-19 Positive according to swab test.

Group Type EXPERIMENTAL

Breath biopsy sampling using the ReCIVA Breath Sampler

Intervention Type DIAGNOSTIC_TEST

Breath biopsy sampling using the ReCIVA Breath Sampler

Healthy subjects

subjects who were found COVID-19 Negative according to swab test.

Group Type OTHER

Breath biopsy sampling using the ReCIVA Breath Sampler

Intervention Type DIAGNOSTIC_TEST

Breath biopsy sampling using the ReCIVA Breath Sampler

Interventions

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Breath biopsy sampling using the ReCIVA Breath Sampler

Breath biopsy sampling using the ReCIVA Breath Sampler

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 55 years at the time of consent
* Positive results for SARS-CoV-2
* Capable of understanding written and/or spoken language
* Able to provide informed consent

Exclusion Criteria

* Age under 18 years old
* (Anticipated) inability to complete breath sampling procedure due to e.g. hyper- or hypoventilation, respiratory failure, or claustrophobia when wearing the sampling mask
* Persons under guardianship or deprived of liberty
* Patients with the following diseases: Cancer, Asthma, Chronic Respiratory Disease
* Pregnant women
* Treated with antiviral drugs upon admission or during hospitalization
* Novices and soldiers in initial training
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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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Natalie Dror, PhD

Role: STUDY_DIRECTOR

Scentech Medical Technologies Ltd

Locations

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IDF COVID 19 Isolation Facility

Ashkelon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Cov-2-IDF

Identifier Type: -

Identifier Source: org_study_id

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