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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04602871

Acronym

COVID-19

Enrollment

Registered

2020-10-26

Start date

2020-07-03

Completion date

2021-01-30

Last updated

2022-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Brief summary

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

Detailed description

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

Interventions

DIAGNOSTIC_TESTBreath Biopsy

Breath Biopsy sampling using the ReCIVA® Breath Sampler

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Correlation between Volatile Organic Compounds pattern in-breath biopsy and COVID-19 detection.	Through the study completion, up to 3 months.	Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection in a swab test.

Secondary

Measure	Time frame	Description
Correlation between Volatile Organic Compounds pattern and the course of the disease	Through the study completion, up to 3 months.	Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection intensity in a swab test.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026