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DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 patients | Experimental | subjects who were found as COVID-19 positive patients by swab RT-PCR |
|
| Healthy controls | Other | subjects who were found as COVID-19 Negative, by swab RT-PCR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath Biopsy Analysis | Diagnostic Test | Analysis of a single breath Biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Volatile Organic Compounds indicating carriers of COVID-19. | Comparison of Volatile Organic Compounds found among COVID-19 carriers and Healthy controls. | Through the study completion, up to 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.). | Correlation level between exhaled biomarkers and participants' demographic characteristics. | Through the study completion, up to 3 months. |
| sensitivity level of biomarkers' algorithm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Dror, PhD | Scentech Medical Technologies Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shamir Medical Center | Be’er Ya‘aqov | Israel |
No IPD is to be shared with other researchers.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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comparison of algorithm's sensitivity level to the sensitivity of COVID-19 swab TEST. |
| Through the study completion, up to 3 months. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |