Early Detection of COVID-19 Using Breath Analysis - Feasibility Study (COVID-19)
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Breath Biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Covid19
Eligibility Criteria
Inclusion Criteria:
Hospitalized group:
- Age 18 to 75 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
- Was not treated with Anti-viral drugs
- Not a pregnant woman
Healthy group:
- Healthy volunteers
- Age 18 to 75 years at the time of consent
- No history of COVID-19
- Capable of understanding written and/or spoken language
- Able to provide informed consent
- Was not treated with Anti-viral drugs
- Not a pregnant woman
Sexes Eligible for Study: All
Exclusion Criteria:
Hospitalized group:
- 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
Healthy group:
- Age under 18 years old
- History of COVID-19
- Persons under guardianship or deprived of liberty
- Subjects with the following diseases: Cancer, Asthma, Chronic Respiratory Disease
Sites / Locations
- Soroka Medical Center
- Meir Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
COVID 19 Positive patients
Healthy subjects
Arm Description
Patients with COVID-19, qPCR for SARS-CoV-2 confirmed
COVID-19 Negative subjects
Outcomes
Primary Outcome Measures
Correlation between Volatile Organic Compounds pattern in-breath biopsy and COVID-19 detection.
Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection in a swab test.
Secondary Outcome Measures
Correlation between Volatile Organic Compounds pattern and the course of the disease
Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection intensity in a swab test.
Full Information
NCT ID
NCT04602871
First Posted
October 21, 2020
Last Updated
May 9, 2022
Sponsor
Scentech Medical Technologies Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04602871
Brief Title
Early Detection of COVID-19 Using Breath Analysis - Feasibility Study
Acronym
COVID-19
Official Title
Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 3, 2020 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
January 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 -Feasibility Study.
Detailed Description
An interventional diagnostic prospective study study with risks and minimal constraints.
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
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVID 19 Positive patients
Arm Type
Experimental
Arm Description
Patients with COVID-19, qPCR for SARS-CoV-2 confirmed
Arm Title
Healthy subjects
Arm Type
Other
Arm Description
COVID-19 Negative subjects
Intervention Type
Diagnostic Test
Intervention Name(s)
Breath Biopsy
Intervention Description
Breath Biopsy sampling using the ReCIVA® Breath Sampler
Primary Outcome Measure Information:
Title
Correlation between Volatile Organic Compounds pattern in-breath biopsy and COVID-19 detection.
Description
Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection 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 the course of the disease
Description
Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection intensity 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
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Hospitalized group:
Age 18 to 75 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
Was not treated with Anti-viral drugs
Not a pregnant woman
Healthy group:
Healthy volunteers
Age 18 to 75 years at the time of consent
No history of COVID-19
Capable of understanding written and/or spoken language
Able to provide informed consent
Was not treated with Anti-viral drugs
Not a pregnant woman
Sexes Eligible for Study: All
Exclusion Criteria:
Hospitalized group:
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
Healthy group:
Age under 18 years old
History of COVID-19
Persons under guardianship or deprived of liberty
Subjects with the following diseases: Cancer, Asthma, Chronic Respiratory Disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Shitrit, MD
Organizational Affiliation
Meir Medical Center, Kfar Saba, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka Medical Center
City
Be'er Sheva
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPDs are to be shared with other researchers.
Learn more about this trial
Early Detection of COVID-19 Using Breath Analysis - Feasibility Study
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