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

Scentech Medical Technologies

Status: Completed

Conditions: Covid19

Treatments: Diagnostic Test: Breath Biopsy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04602871

Cov-2-2020

Details and patient eligibility

About

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

Full description

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

Enrollment: 54 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

54 participants in 2 patient groups

COVID 19 Positive patients

Experimental group

Description:

Patients with COVID-19, qPCR for SARS-CoV-2 confirmed

Treatment:

Diagnostic Test: Breath Biopsy

Healthy subjects

Other group

Description:

COVID-19 Negative subjects

Treatment:

Diagnostic Test: Breath Biopsy