Detection of COVID-19 Subjects Using DiaNose Exhalation Test
NCT ID: NCT04476927
Last Updated: 2020-07-20
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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UNKNOWN
NA
300 participants
INTERVENTIONAL
2020-08-01
2021-06-30
Brief Summary
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up to 300 subjects will be enrolled to the study ( 200 COVID-19 suspected and 100 healthy volunteers in two clinical sites (1 in Israel and 1 in US).
DiaNose system is an electronic nose device that can "smell" diseases in the exhaled breath of patients in real time. This approach is non-invasive, simple and save.
The DiaNose prototype system consists the following elements:
A Soft Tube connected to a Sensors Chamber - The soft tube is made of medical grade silicon. The subject blows air into the tube for a few seconds and the exhaled air is directed through the sensors chamber. This unit is for single use.
• Sensors Reading Unit- a multi used unit for sensors signals measurement. The Sensor Reading Unit is connected to a Laptop that is used to activate and save the test measurements.
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Detailed Description
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Subjects which are COVID-19 infected suspected (Group 1); and healthy volunteers (Group 2), will be the study population. The study will encompass a total of up to 300 patients.
The COVID-19 infected suspected study group will be divided for the data analyzing and algorithm building into the following sub-groups (up to 200 subjects):
* Sub-Group A: Clinical symptomatic patients with positive Covid-19 test (positive PCR);
* Sub-Group B: Asymptomatic patients with positive Covid-19 test (positive PCR)
* Sub-Group C: Clinical symptomatic patients with negative Covid-19 test (negative PCR) Additional sub-groups may be added according to clinical symptoms. Up to 100 will be enrolled to the Healthy volunteers' study group. Subjects who meet general entry criteria will be asked to sign the study-specific Informed Consent Form the patient will be required not to eat/ smoke/ chewing gum or drink beverage other than water for one hour prior to the DiaNose exhalation test.
The patient will be asked to blow air into a disposable tube for a few seconds. Subject may be re-enrolled in case of need to perform additional PCR test and/or breath test with DiaNose according to standard of care or due to the study needs.
It is anticipated that it will require approximately 12 months to complete active enrollment.
Conditions
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Study Design
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NA
SINGLE_GROUP
For data analysis and algorithm building, subjects will be divided into one of the following study groups:
* Group 1: Covid-19 infected suspected (up to 300 subjects)
* Sub-Group A: Clinical symptomatic patients with positive Covid-19 test (positive PCR);
* Sub-Group B: Asymptomatic patients with positive Covid-19 test (positive PCR)
* Sub-Group C: Clinical symptomatic patients with negative Covid-19 test (negative PCR) Additional sub-groups may be added according to clinical symptoms.
* Group 2: Healthy volunteers (up to 100 subjects)
OTHER
NONE
Study Groups
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DiaNose procedure
all subjects will be required to undergo the DiaNose exhalation test.
DiaNose
DiaNose system is an electronic nose device that can "smell" diseases in the exhaled breath of patients in real time. The recognition of Volatile Organic Compounds (VOCs) in breath samples approach is non-invasive and for safe diagnosis of diseases.
The DiaNose prototype system consists the following elements:
* A Soft Tube connected to a Sensors Chamber - The soft tube is made of medical grade silicon. The subject blows air into the tube for a few seconds and the exhaled air is directed through the sensors chamber. This unit is for single use.
* Sensors Reading Unit- a multi used unit for sensors signals measurement. The Sensor Reading Unit is connected to a Laptop either via a Data Acquisition Instrument - Commercial unit for resistance measurements (https://www.tek.com/keithley-switching-and-data-acquisition-systems/keithley-daq6510) (option A ) or directly by a USB cable (option B).
* Laptop - Laptop is used to activate and save the test measurements.
Interventions
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DiaNose
DiaNose system is an electronic nose device that can "smell" diseases in the exhaled breath of patients in real time. The recognition of Volatile Organic Compounds (VOCs) in breath samples approach is non-invasive and for safe diagnosis of diseases.
The DiaNose prototype system consists the following elements:
* A Soft Tube connected to a Sensors Chamber - The soft tube is made of medical grade silicon. The subject blows air into the tube for a few seconds and the exhaled air is directed through the sensors chamber. This unit is for single use.
* Sensors Reading Unit- a multi used unit for sensors signals measurement. The Sensor Reading Unit is connected to a Laptop either via a Data Acquisition Instrument - Commercial unit for resistance measurements (https://www.tek.com/keithley-switching-and-data-acquisition-systems/keithley-daq6510) (option A ) or directly by a USB cable (option B).
* Laptop - Laptop is used to activate and save the test measurements.
Eligibility Criteria
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Inclusion Criteria
1. Subject ≥18 years of age
2. Verified exposure to COVID-19 virus
3. Physical or Radiological evidence of Pneumonia or other Upper Respiratory Tract Infection
4. Subject with at least one of the following symptoms: Fever \>37.80c P.O with no alternative source for infection / Cough / Nasal discharge or congestion / Shortness of breath (subjective or objective) with no alternative explanation / Sore throat / Loss of taste and smell / Combination of headache, general malaise, fatigue or other nonspecific URTI (upper respiratory tract infection) symptoms / GI symptoms (not as a signal symptom)
5. Subject has undergone PCR test or is about to undergo the test immediately
6. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
7. Subject is able and willing to adhere to the required testing
Exclusion Criteria
2. Subject addicted to alcohol and/or drugs
3. Subject with active gingivitis
4. Subject with COPD (Chronic Obstructive Pulmonary Disease)
5. During the last hour before examination the subject ate including chewing gum / smoked/ Drank (any drink beside water)/performed excessive physical activity
6. Subject is pregnant (confirmed by subject declaration)
18 Years
ALL
Yes
Sponsors
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Nanose Medical Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ravit Peled
Role: STUDY_DIRECTOR
Nanose Medical
Central Contacts
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Other Identifiers
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CORON01
Identifier Type: -
Identifier Source: org_study_id
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