Back to resultsDetection of COVID-19 Using Breath Analysis - Validation Study (COVID-19)
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Breath Biopsy Analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Age 6 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 6 years old
- Under guardianship or deprived of liberty
- Pregnant or lactating woman
Sites / Locations
- Shamir Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
COVID-19 patients
Healthy controls
Arm Description
subjects who were found as COVID-19 positive patients by swab RT-PCR
subjects who were found as COVID-19 Negative, by swab RT-PCR
Outcomes
Primary Outcome Measures
Presence of Volatile Organic Compounds indicating carriers of COVID-19.
Comparison of Volatile Organic Compounds found among COVID-19 carriers and Healthy controls.
Secondary Outcome Measures
Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.).
Correlation level between exhaled biomarkers and participants' demographic characteristics.
sensitivity level of biomarkers' algorithm.
comparison of algorithm's sensitivity level to the sensitivity of COVID-19 swab TEST.
Full Information
NCT ID
NCT04602949
First Posted
October 21, 2020
Last Updated
May 14, 2023
Sponsor
Scentech Medical Technologies Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04602949
Brief Title
Detection of COVID-19 Using Breath Analysis - Validation Study
Acronym
COVID-19
Official Title
Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Validation Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
May 28, 2022 (Actual)
Study Completion Date
January 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scentech Medical Technologies Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY
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 us to distinguish between Coronavirus (SARS-CoV-2) carriers and SARS-CoV-2-negative in comparison to the gold-standard testing methodology.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2558 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVID-19 patients
Arm Type
Experimental
Arm Description
subjects who were found as COVID-19 positive patients by swab RT-PCR
Arm Title
Healthy controls
Arm Type
Other
Arm Description
subjects who were found as COVID-19 Negative, by swab RT-PCR
Intervention Type
Diagnostic Test
Intervention Name(s)
Breath Biopsy Analysis
Intervention Description
Analysis of a single breath Biopsy
Primary Outcome Measure Information:
Title
Presence of Volatile Organic Compounds indicating carriers of COVID-19.
Description
Comparison of Volatile Organic Compounds found among COVID-19 carriers and Healthy controls.
Time Frame
Through the study completion, up to 3 months.
Secondary Outcome Measure Information:
Title
Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.).
Description
Correlation level between exhaled biomarkers and participants' demographic characteristics.
Time Frame
Through the study completion, up to 3 months.
Title
sensitivity level of biomarkers' algorithm.
Description
comparison of algorithm's sensitivity level to the sensitivity of COVID-19 swab TEST.
Time Frame
Through the study completion, up to 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 6 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 6 years old
Under guardianship or deprived of liberty
Pregnant or lactating woman
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Dror, PhD
Organizational Affiliation
Scentech Medical Technologies Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Shamir Medical Center
City
Be'er Ya'aqov
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD is to be shared with other researchers.
Learn more about this trial
Detection of COVID-19 Using Breath Analysis - Validation Study
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