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NCT04602871 | Completed | Covid19

Early Detection of COVID-19 Using Breath Analysis - Feasibility Study
Sponsor:

Scentech Medical Technologies Ltd

Brief Summary:

Early Detection of COVID-19 Using Breath Analysis -Feasibility Study.

Condition or disease

Covid19

Intervention/treatment

Breath Biopsy

Phase

Not Applicable

Detailed Description:

An interventional diagnostic prospective study study with risks and minimal constraints.}}

Study Type : Interventional
Estimated Enrollment : 54 participants
Masking : None (Open Label)
Primary Purpose : Diagnostic
Official Title : Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Feasibility Study
Actual Study Start Date : July 3, 2020
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : January 30, 2021
Arm Intervention/treatment

Experimental: COVID 19 Positive patients

Patients with COVID-19, qPCR for SARS-CoV-2 confirmed

Diagnostic Test: Breath Biopsy

Other: Healthy subjects

COVID-19 Negative subjects

Diagnostic Test: Breath Biopsy
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Hospitalized group
    • Age 18 to 75 years at the time of consent
    • Positive results for SARS-CoV-2
    • Capable of understanding written and/or spoken language
    • Able to provide informed consent
    • Was not treated with Anti-viral drugs
    • Not a pregnant woman
    • Healthy group
      • Healthy volunteers
      • Age 18 to 75 years at the time of consent
      • No history of COVID-19
      • Capable of understanding written and/or spoken language
      • Able to provide informed consent
      • Was not treated with Anti-viral drugs
      • Not a pregnant woman
      • Sexes Eligible for Study: All
      Exclusion Criteria
      • Hospitalized group
        • Age under 18 years old
        • (Anticipated) inability to complete breath sampling procedure due to e.g. hyper- or hypoventilation, respiratory failure or claustrophobia when wearing the sampling mask
        • Persons under guardianship or deprived of liberty
        • Patients with the following diseases: Cancer, Asthma, Chronic Respiratory Disease
        • Healthy group
          • Age under 18 years old
          • History of COVID-19
          • Persons under guardianship or deprived of liberty
          • Subjects with the following diseases: Cancer, Asthma, Chronic Respiratory Disease
Early Detection of COVID-19 Using Breath Analysis - Feasibility Study

Location Details

Please Choose a site

Early Detection of COVID-19 Using Breath Analysis - Feasibility Study

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Israel,

Soroka Medical Center

Be'er Sheva, Israel,

Not yet recruiting

Israel,

Meir Medical Center

Kafr Saba, Israel,