Detection of COVID-19 Using Breath Analysis - Validation Study.

• Sponsor: Scentech Medical Technologies Ltd (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05224622
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 15.9
• Patients Per Site Per Month: 31.4

Study Details

Study Description

Brief Summary

Detection of the 2019 novel Coronavirus (SARS-CoV-2) using breath analysis - Validation study.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Diagnostic Test: VOX	N/A

Detailed 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 the investigator to distinguish between COVID-19 carriers and COVID-19 non-carriers in comparison to the gold-standard testing methodology.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Validation Study.
• Actual Study Start Date: Jan 18, 2022
• Anticipated Primary Completion Date: Mar 18, 2023
• Anticipated Study Completion Date: May 18, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Drive In Drive In attendees will undergo one breath sampling.	Diagnostic Test: VOX; Breath exhalation into the mouthpiece of the VOX breath diagnostic device.
Experimental: Healthy Healthy attendees will undergo two successive breath sampling.	Diagnostic Test: VOX; Breath exhalation into the mouthpiece of the VOX breath diagnostic device.
Experimental: Corona Department Healthy attendees will undergo five successive breath sampling.	Diagnostic Test: VOX; Breath exhalation into the mouthpiece of the VOX breath diagnostic device.

Outcome Measures

Primary Outcome Measures

1. Presence of Volatile Organic Compounds indicating carriers of COVID-19. [Through the study completion, up to 3 months.]

   Obtain early verification accuracy of measures for a set of VOCs biomarkers indicating carriers of Corona virus.

Secondary Outcome Measures

1. Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.) [Through the study completion, up to 3 months.]

   Correlation level between exhaled biomarkers and participants' demographic characteristics.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 18 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 18 years old

• Under guardianship or deprived of liberty

• Pregnant or lactating woman

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Poriya Medical Center	Poriyya		Israel	1528001

Sponsors and Collaborators

• Scentech Medical Technologies Ltd

Investigators

• Principal Investigator: Avi Peretz, PhD, Poriya Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Scentech Medical Technologies Ltd
• ClinicalTrials.gov Identifier: NCT05224622
• Other Study ID Numbers: COV-2-PMC-2021
• First Posted: Feb 4, 2022
• Last Update Posted: Aug 9, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Aug 9, 2022