Detection of COVID-19 Using Breath Analysis - Validation Study

Scentech Medical Technologies

Status: Completed

Conditions: Covid19

Treatments: Diagnostic Test: Breath Biopsy Analysis

Study type: Interventional

Funder types: Industry

Identifiers

NCT04602949

Cov-2-SMC-2020

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 us to distinguish between Coronavirus (SARS-CoV-2) carriers and SARS-CoV-2-negative in comparison to the gold-standard testing methodology.

Enrollment: 2,558 patients

Sex: All

Ages: 6 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 6 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 6 years old
• Under guardianship or deprived of liberty
• Pregnant or lactating woman

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,558 participants in 2 patient groups

COVID-19 patients

Experimental group

Description:

subjects who were found as COVID-19 positive patients by swab RT-PCR

Treatment:

Diagnostic Test: Breath Biopsy Analysis

Healthy controls

Other group

Description:

subjects who were found as COVID-19 Negative, by swab RT-PCR

Treatment:

Diagnostic Test: Breath Biopsy Analysis