COVID-19NCT04476927
Detection of COVID-19 Subjects Using DiaNose Exhalation Test
A study testing DiaNose in people with COVID-19, run by Nanose Medical Ltd..
Trial summary
The study aim is to collect and analyze data of potential Volatile Organic Compounds (VOCs) that could be used for discriminating between patients with and without COVID-19 or with high-risk for COVID-19 by DiaNose breath test. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- DiaNose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Corona Suspected Subjects
- Subject ≥18 years of age
- Verified exposure to COVID-19 virus
- Physical or Radiological evidence of Pneumonia or other Upper Respiratory Tract Infection
- 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)
- Subject has undergone PCR test or is about to undergo the test immediately
- Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
- Subject is able and willing to adhere to the required testing
Who cannot join
- Subject with HIV
- Subject addicted to alcohol and/or drugs
- Subject with active gingivitis
- Subject with COPD (Chronic Obstructive Pulmonary Disease)
- During the last hour before examination the subject ate including chewing gum / smoked/ Drank (any drink beside water)/performed excessive physical activity
- Subject is pregnant (confirmed by subject declaration)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Collecting and Evaluating Data of Potential Volatile Biomarkers in the Exhaled Air of Subjects With and Without COVID-19 by DiaNose
The study aim is to collect and analyze data of potential Volatile Organic Compounds (VOCs) that could be used for discriminating between patients with and without COVID-19 or with high-risk for COVID-19 by DiaNose breath test.
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).
Read more
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.
Read the detailed description
This study is a prospective, multi-center research clinical study. The aim of this study is to collect and analyze data of potential Volatile Organic Compounds (VOCs) that could be used for discriminating between patients with and without COVID-19 or with high-risk for COVID-19 by DiaNose. The VOC profile of exhaled breath from subjects with COVID-19 infected suspected; and healthy volunteers, will be collected and analyzed to build and validate a predictive algorithmic model for diagnosing COVID 19.
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
- COVID-19
- Being tested
- DiaNose
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaNoseDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| DiaNose procedure | Experimental | all subjects will be required to undergo the DiaNose exhalation test. Receives: Device: DiaNose |
What is being measured
The primary outcome is the main question the study is designed to answer.
collecting and analyzing of DiaNose sensors signals from potential VOC markers in the breath samples of all subjects to build and validate a predictive algorithmic model for diagnosing COVID 19.
Sensing Features (SFs) extracted from each of the sensors are used for statistical analysis by artificially intelligent/pattern recognition algorithm.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Aug 2020 (estimated)
- Primary completion30 May 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Total of 300 subjects - 200 suspected to COVID-19 and 100 healthy volunteers. all subjects will be undergo the DiaNose test. 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)
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanose Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravit Peled, Study director, Nanose Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476927
- Sponsor's protocol ID
- CORON01
- Status last verified
- Jul 2020
- First submitted
- 16 Jun 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collecting and Evaluating Data of Potential Volatile Biomarkers in the Exhaled Air of Subjects With and Without COVID-19 by DiaNose
- ClinicalTrials.gov ID
- NCT04476927
- Acronym / sponsor ID
- CORON01
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanose Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aim is to collect and analyze data of potential Volatile Organic Compounds (VOCs) that could be used for discriminating between patients with and without COVID-19 or with high-risk for COVID-19 by DiaNose breath test.
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.
Detailed description
This study is a prospective, multi-center research clinical study. The aim of this study is to collect and analyze data of potential Volatile Organic Compounds (VOCs) that could be used for discriminating between patients with and without COVID-19 or with high-risk for COVID-19 by DiaNose. The VOC profile of exhaled breath from subjects with COVID-19 infected suspected; and healthy volunteers, will be collected and analyzed to build and validate a predictive algorithmic model for diagnosing COVID 19.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Total of 300 subjects - 200 suspected to COVID-19 and 100 healthy volunteers. all subjects will be undergo the DiaNose test. 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)
| Arm | Type | Receives |
|---|---|---|
| DiaNose procedure | Experimental | Device: DiaNoseall subjects will be required to undergo the DiaNose exhalation test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Corona Suspected Subjects
- Subject ≥18 years of age
- Verified exposure to COVID-19 virus
- Physical or Radiological evidence of Pneumonia or other Upper Respiratory Tract Infection
- 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)
Key exclusion criteria (6 listed)
- Subject with HIV
- Subject addicted to alcohol and/or drugs
- Subject with active gingivitis
- Subject with COPD (Chronic Obstructive Pulmonary Disease)
- During the last hour before examination the subject ate including chewing gum / smoked/ Drank (any drink beside water)/performed excessive physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiaNoseDiaNose 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. | Device | DiaNose procedure |
Primary outcome
collecting and analyzing of DiaNose sensors signals from potential VOC markers in the breath samples of all subjects to build and validate a predictive algorithmic model for diagnosing COVID 19.
Time frame: 1 hour
Sensing Features (SFs) extracted from each of the sensors are used for statistical analysis by artificially intelligent/pattern recognition algorithm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravit Peled study director
Nanose Medical
Questions about this trial
What is this clinical trial studying?
A study testing DiaNose in people with COVID-19, run by Nanose Medical Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ravit Peled (+972 526145354, ravitp@nanosemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collecting and analyzing of DiaNose sensors signals from potential VOC markers in the breath samples of all subjects to build and validate a predictive algorithmic model for diagnosing COVID 19. (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.