Detection of COVID-19 Using Breath Analysis - Validation Study.

Scentech Medical Technologies

Status: Completed

Conditions: COVID-19

Treatments: Diagnostic Test: VOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT05224622

COV-2-PMC-2021

Details and patient eligibility

About

Detection of the 2019 novel Coronavirus (SARS-CoV-2) using breath analysis - Validation study.

Full description

A diagnostic prospective single-site study, with no anticipated risks or constraints.

Primary objective- To validate the value of a set of breath VOC biomarkers that enable the investigator to distinguish between COVID-19 carriers and COVID-19 non-carriers in comparison to the gold-standard testing methodology.

Enrollment: 192 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 to 75 years at the time of consent
• Capable of understanding written and/or spoken language
• Able to provide informed consent
• Was not treated with Anti-viral drugs

Exclusion criteria

• Age under 18 years old
• Under guardianship or deprived of liberty
• Pregnant or lactating woman

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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192 participants in 3 patient groups

Drive In

Experimental group

Description:

Drive In attendees will undergo one breath sampling.

Treatment:

Diagnostic Test: VOX

Healthy

Experimental group

Description:

Healthy attendees will undergo two successive breath sampling.

Treatment:

Diagnostic Test: VOX

Corona Department

Experimental group

Description:

Healthy attendees will undergo five successive breath sampling.

Treatment:

Diagnostic Test: VOX