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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 the investigator to distinguish between COVID-19 carriers and COVID-19 non-carriers in comparison to the gold-standard testing methodology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drive In | Experimental | Drive In attendees will undergo one breath sampling. |
|
| Healthy | Experimental | Healthy attendees will undergo two successive breath sampling. |
|
| Corona Department | Experimental | Healthy attendees will undergo five successive breath sampling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VOX | Diagnostic Test | Breath exhalation into the mouthpiece of the VOX breath diagnostic device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Volatile Organic Compounds indicating carriers of COVID-19. | Obtain early verification accuracy of measures for a set of VOCs biomarkers indicating carriers of Corona virus. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avi Peretz, PhD | Poriya Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poriya Medical Center | Poria – Neve Oved | 1528001 | Israel |
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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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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |