FDA submission of Nanose medical

Study Description

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.

	Condition or disease	Intervention/treatment	Phase
1	COVID-19	Device: DiaNose	Not Applicable

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.