Early Detection of COVID-19 Using Breath Analysis - Feasibility Study

NCT ID: NCT04602871

Last Updated: 2022-05-10

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-03

Study Completion Date

2021-01-30

Brief Summary

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Early Detection of COVID-19 Using Breath Analysis -Feasibility Study.

Detailed Description

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An interventional diagnostic prospective study study with risks and minimal constraints.

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

Patients with COVID-19, qPCR for SARS-CoV-2 confirmed

Group Type EXPERIMENTAL

Breath Biopsy

Intervention Type DIAGNOSTIC_TEST

Breath Biopsy sampling using the ReCIVA® Breath Sampler

Healthy subjects

COVID-19 Negative subjects

Group Type OTHER

Breath Biopsy

Intervention Type DIAGNOSTIC_TEST

Breath Biopsy sampling using the ReCIVA® Breath Sampler

Interventions

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Breath Biopsy

Breath Biopsy sampling using the ReCIVA® Breath Sampler

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Hospitalized group:

* Age 18 to 75 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
* Was not treated with Anti-viral drugs
* Not a pregnant woman

Healthy group:

* Healthy volunteers
* Age 18 to 75 years at the time of consent
* No history of COVID-19
* Capable of understanding written and/or spoken language
* Able to provide informed consent
* Was not treated with Anti-viral drugs
* Not a pregnant woman

Sexes Eligible for Study: All

Exclusion Criteria

Hospitalized group:

* 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

Healthy group:

* Age under 18 years old
* History of COVID-19
* Persons under guardianship or deprived of liberty
* Subjects with the following diseases: Cancer, Asthma, Chronic Respiratory Disease
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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David Shitrit, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center, Kfar Saba, Israel

Locations

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Soroka Medical Center

Beersheba, , Israel

Site Status

Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Cov-2-2020

Identifier Type: -

Identifier Source: org_study_id

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