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CompletedNCT05224622Updated May 31, 2023

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

An interventional study of VOX in COVID-19, sponsored by Scentech Medical Technologies Ltd. Completed at 1 site in Israel. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-31.

Sponsored by Scentech Medical Technologies Ltd · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
192
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • COVID-19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 192 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Scentech Medical Technologies Ltd is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

Exclusion Criteria:

  • Age under 18 years old
  • Under guardianship or deprived of liberty
  • Pregnant or lactating woman
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
192 participants (actual)

Study arms

  • Experimental
    Drive In

    Drive In attendees will undergo one breath sampling.

    Diagnostic Test: VOX

  • Experimental
    Healthy

    Healthy attendees will undergo two successive breath sampling.

    Diagnostic Test: VOX

  • Experimental
    Corona Department

    Healthy attendees will undergo five successive breath sampling.

    Diagnostic Test: VOX

Interventions

  • Diagnostic testVOX

    Breath exhalation into the mouthpiece of the VOX breath diagnostic device.

06

What researchers measure

Primary outcomes

  1. Presence of Volatile Organic Compounds indicating carriers of COVID-19.

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

    Time frame: Through the study completion, up to 3 months.

Secondary outcomes

  1. Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.)

    Correlation level between exhaled biomarkers and participants' demographic characteristics.

    Time frame: Through the study completion, up to 3 months.

07

Study locations

1 site
  • Poriya Medical Center
    Poriyya, 1528001, Israel
08

References and documents

Individual participant data

Plan to share: No — No IPD

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05224622
Lead sponsor
Scentech Medical Technologies Ltd
Responsible party
Sponsor
First posted
Feb 4, 2022
Start date
Jan 18, 2022
Primary completion
May 28, 2022
Completion
Jan 18, 2023
Last update
May 31, 2023

Study contacts

Avi Peretz, PhD
principal investigator · Poriya Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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