Early Detection of COVID-19 Using Breath Analysis

Scentech Medical Technologies

Status: Completed

Conditions: Covid19

Treatments: Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler

Study type: Interventional

Funder types: Industry

Identifiers

NCT04602884

Cov-2-IDF

Details and patient eligibility

About

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

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

COVID-19 Positive patients

Experimental group

Description:

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

Treatment:

Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler

Healthy subjects

Other group

Description:

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

Treatment:

Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler