Early Detection of COVID-19 Using Breath Analysis - Feasibility Study
NCT ID: NCT04602871
Last Updated: 2022-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2020-07-03
2021-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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COVID 19 Positive patients
Patients with COVID-19, qPCR for SARS-CoV-2 confirmed
Breath Biopsy
Breath Biopsy sampling using the ReCIVA® Breath Sampler
Healthy subjects
COVID-19 Negative subjects
Breath Biopsy
Breath Biopsy sampling using the ReCIVA® Breath Sampler
Interventions
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Breath Biopsy
Breath Biopsy sampling using the ReCIVA® Breath Sampler
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Scentech Medical Technologies Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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David Shitrit, MD
Role: PRINCIPAL_INVESTIGATOR
Meir Medical Center, Kfar Saba, Israel
Locations
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Soroka Medical Center
Beersheba, , Israel
Meir Medical Center
Kfar Saba, , Israel
Countries
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Other Identifiers
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Cov-2-2020
Identifier Type: -
Identifier Source: org_study_id
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