- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05224622
Detection of COVID-19 Using Breath Analysis - Validation Study.
May 28, 2023 updated by: Scentech Medical Technologies Ltd
Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Validation Study.
Detection of the 2019 novel Coronavirus (SARS-CoV-2) using breath analysis - Validation study.
Study Overview
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 Type
Interventional
Enrollment (Actual)
192
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Poriyya, Israel, 1528001
- Poriya Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Drive In
Drive In attendees will undergo one breath sampling.
|
Breath exhalation into the mouthpiece of the VOX breath diagnostic device.
|
Experimental: Healthy
Healthy attendees will undergo two successive breath sampling.
|
Breath exhalation into the mouthpiece of the VOX breath diagnostic device.
|
Experimental: Corona Department
Healthy attendees will undergo five successive breath sampling.
|
Breath exhalation into the mouthpiece of the VOX breath diagnostic device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of Volatile Organic Compounds indicating carriers of COVID-19.
Time Frame: 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.
|
Through the study completion, up to 3 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.)
Time Frame: Through the study completion, up to 3 months.
|
Correlation level between exhaled biomarkers and participants' demographic characteristics.
|
Through the study completion, up to 3 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Avi Peretz, PhD, Poriya Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 18, 2022
Primary Completion (Actual)
May 28, 2022
Study Completion (Actual)
January 18, 2023
Study Registration Dates
First Submitted
February 3, 2022
First Submitted That Met QC Criteria
February 3, 2022
First Posted (Actual)
February 4, 2022
Study Record Updates
Last Update Posted (Actual)
May 31, 2023
Last Update Submitted That Met QC Criteria
May 28, 2023
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COV-2-PMC-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No IPD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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