Back to resultsEarly Detection of COVID-19 Using Breath Analysis (COVID-19)
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Breath biopsy sampling using the ReCIVA Breath Sampler
Sponsored by
About this trial
This is an interventional diagnostic trial for Covid19
Eligibility Criteria
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
Sites / Locations
- IDF COVID 19 Isolation Facility
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
COVID-19 Positive patients
Healthy subjects
Arm Description
subjects who were found COVID-19 Positive according to swab test.
subjects who were found COVID-19 Negative according to swab test.
Outcomes
Primary Outcome Measures
Correlation between Volatile Organic Compounds pattern and COVID-19 detection status.
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.
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.
Correlation between the set of Volatile Organic Compounds found in breath biopsy and intensity of COVID-19 detected in a swab test.
Full Information
NCT ID
NCT04602884
First Posted
October 21, 2020
Last Updated
February 3, 2022
Sponsor
Scentech Medical Technologies Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04602884
Brief Title
Early Detection of COVID-19 Using Breath Analysis
Acronym
COVID-19
Official Title
Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis: First Cross-Sectional Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (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
EARLY DETECTION OF COVID-19 USING BREATH ANALYSIS- FIRST CROSS-SECTIONAL STUDY
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.
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
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVID-19 Positive patients
Arm Type
Experimental
Arm Description
subjects who were found COVID-19 Positive according to swab test.
Arm Title
Healthy subjects
Arm Type
Other
Arm Description
subjects who were found COVID-19 Negative according to swab test.
Intervention Type
Diagnostic Test
Intervention Name(s)
Breath biopsy sampling using the ReCIVA Breath Sampler
Intervention Description
Breath biopsy sampling using the ReCIVA Breath Sampler
Primary Outcome Measure Information:
Title
Correlation between Volatile Organic Compounds pattern and COVID-19 detection status.
Description
Correlation between the set of Volatile Organic Compounds found in breath biopsy and COVID-19 detection presence in a swab test.
Time Frame
Through the study completion, up to 3 months.
Secondary Outcome Measure Information:
Title
Correlation between Volatile Organic Compounds pattern and time from COVID-19 detection.
Description
Correlation between the set of Volatile Organic Compounds found in breath biopsy and time since COVID-19 detected in a swab test.
Time Frame
Through the study completion, up to 3 months.
Title
Correlation between the set of Volatile Organic Compounds found in breath biopsy and disease intensity.
Description
Correlation between the set of Volatile Organic Compounds found in breath biopsy and intensity of COVID-19 detected in a swab test.
Time Frame
Through the study completion, up to 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
IDF COVID 19 Isolation Facility
City
Ashkelon
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
Early Detection of COVID-19 Using Breath Analysis
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