Early Detection of COVID-19 Using Breath Analysis

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler

• Registration Number: NCT04602884
• Lead Sponsor: Scentech Medical Technologies Ltd

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-09-22
• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-23
• Study First Posted: 2020-10-26
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy subjects	Breath biopsy sampling using the ReCIVA Breath Sampler	subjects who were found COVID-19 Negative according to swab test.
COVID-19 Positive patients	Breath biopsy sampling using the ReCIVA Breath Sampler	subjects who were found COVID-19 Positive according to swab test.

Primary Outcome Measures

Name	Time	Method
Correlation between Volatile Organic Compounds pattern and COVID-19 detection status.	Through the study completion, up to 3 months.	Correlation between the set of Volatile Organic Compounds found in breath biopsy and COVID-19 detection presence in a swab test.

Secondary Outcome Measures

Name	Time	Method
Correlation between Volatile Organic Compounds pattern and time from COVID-19 detection.	Through the study completion, up to 3 months.	Correlation between the set of Volatile Organic Compounds found in breath biopsy and time since COVID-19 detected in a swab test.
Correlation between the set of Volatile Organic Compounds found in breath biopsy and disease intensity.	Through the study completion, up to 3 months.	Correlation between the set of Volatile Organic Compounds found in breath biopsy and intensity of COVID-19 detected in a swab test.

Trial Locations

Locations (1)

IDF COVID 19 Isolation Facility; 🇮🇱 Ashkelon, Israel