Early Detection of COVID-19 Using Breath Analysis

Sponsor

Scentech Medical Technologies Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT04602884

Collaborator

(none)

Enrollment

Location

Arms

15.2

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid19	Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis: First Cross-Sectional Study

Actual Study Start Date :

Sep 22, 2020

Actual Primary Completion Date :

Dec 30, 2021

Actual Study Completion Date :

Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: COVID-19 Positive patients subjects who were found COVID-19 Positive according to swab test.	Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler Breath biopsy sampling using the ReCIVA Breath Sampler
Other: Healthy subjects subjects who were found COVID-19 Negative according to swab test.	Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler Breath biopsy sampling using the ReCIVA Breath Sampler

Arm

Intervention/Treatment

Experimental: COVID-19 Positive patients

subjects who were found COVID-19 Positive according to swab test.

Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler

Breath biopsy sampling using the ReCIVA Breath Sampler

Other: Healthy subjects

subjects who were found COVID-19 Negative according to swab test.

Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler

Breath biopsy sampling using the ReCIVA Breath Sampler

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IDF COVID 19 Isolation Facility	Ashkelon		Israel

Sponsors and Collaborators

Scentech Medical Technologies Ltd

Investigators

Study Director: Natalie Dror, PhD, Scentech Medical Technologies Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Scentech Medical Technologies Ltd

ClinicalTrials.gov Identifier:

NCT04602884

Other Study ID Numbers:

Cov-2-IDF

First Posted:

Oct 26, 2020

Last Update Posted:

Feb 7, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Feb 7, 2022