Early Detection of COVID-19 Using Breath Analysis
COVID-19
Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis: First Cross-Sectional Study
1 other identifier
interventional
50
1 country
1
Brief Summary
EARLY DETECTION OF COVID-19 USING BREATH ANALYSIS- FIRST CROSS-SECTIONAL STUDY
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started Sep 2020
Typical duration for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 22, 2020
CompletedFirst Submitted
Initial submission to the registry
October 21, 2020
CompletedFirst Posted
Study publicly available on registry
October 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedFebruary 7, 2022
February 1, 2022
1.3 years
October 21, 2020
February 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Through the study completion, up to 3 months.
Secondary Outcomes (2)
Correlation between Volatile Organic Compounds pattern and time from COVID-19 detection.
Through the study completion, up to 3 months.
Correlation between the set of Volatile Organic Compounds found in breath biopsy and disease intensity.
Through the study completion, up to 3 months.
Study Arms (2)
COVID-19 Positive patients
EXPERIMENTALsubjects who were found COVID-19 Positive according to swab test.
Healthy subjects
OTHERsubjects who were found COVID-19 Negative according to swab test.
Interventions
Breath biopsy sampling using the ReCIVA Breath Sampler
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IDF COVID 19 Isolation Facility
Ashkelon, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Natalie Dror, PhD
Scentech Medical Technologies Ltd
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2020
First Posted
October 26, 2020
Study Start
September 22, 2020
Primary Completion
December 30, 2021
Study Completion
December 30, 2021
Last Updated
February 7, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share
No IPD is to be shared with other researchers.