Status:
UNKNOWN
Detection of COVID-19 Subjects Using DiaNose Exhalation Test
Lead Sponsor:
Nanose Medical Ltd.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 discrimina...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04476927
Start Date
August 1 2020
End Date
June 30 2021
Last Update
July 20 2020
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