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

N/ACompletedNCT04602871

Scentech Medical Technologies Ltd54 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Covid19

Interventions

Breath BiopsyDIAGNOSTIC_TEST

Breath Biopsy sampling using the ReCIVA® Breath Sampler

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Soroka Medical Center

Beersheba, Israel

Meir Medical Center

Kfar Saba, Israel

Outcomes

Primary Outcomes

Correlation between Volatile Organic Compounds pattern in-breath biopsy and COVID-19 detection.

Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection in a swab test.

Time frame: Through the study completion, up to 3 months.

Secondary Outcomes

Correlation between Volatile Organic Compounds pattern and the course of the disease

Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection intensity in a swab test.

Time frame: Through the study completion, up to 3 months.

Data from ClinicalTrials.gov

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