Detection of COVID-19 Subjects Using DiaNose Exhalation Test

NCT04476927 | Unknown FDA Device

• 1 other identifier: CORON01
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour

Study Arms (1)

DiaNose procedure

EXPERIMENTAL

all subjects will be required to undergo the DiaNose exhalation test.

Device: DiaNose

Interventions

DiaNose DEVICE

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.

DiaNose procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nanose Medical Ltd.: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ravit Peled

  Nanose Medical

  STUDY DIRECTOR

Central Study Contacts

Ravit Peled

CONTACT

+972 526145354; ravitp@nanosemed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: July 20, 2020
• Study Start: August 1, 2020
• Primary Completion: May 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 20, 2020

Record last verified: 2020-07