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

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Diagnostic Test: Breath Biopsy

• Registration Number: NCT04602871
• Lead Sponsor: Scentech Medical Technologies Ltd

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.

Study Timeline

• Study Start: 2020-07-03
• Status Verified: 2020-10
• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-23
• Study First Posted: 2020-10-26
• Primary Completion: 2021-01-30
• Study Completion: 2021-01-30
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COVID 19 Positive patients	Breath Biopsy	Patients with COVID-19, qPCR for SARS-CoV-2 confirmed
Healthy subjects	Breath Biopsy	COVID-19 Negative subjects

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Soroka Medical Center; 🇮🇱 Be'er Sheva, Israel

Meir Medical Center; 🇮🇱 Kfar Saba, Israel