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Clinical Trials/NCT04602871
NCT04602871
Completed
Not Applicable

Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Feasibility Study

Scentech Medical Technologies Ltd2 sites in 1 country54 target enrollmentJuly 3, 2020
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ConditionsCovid19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Scentech Medical Technologies Ltd
Enrollment
54
Locations
2
Primary Endpoint
Correlation between Volatile Organic Compounds pattern in-breath biopsy and COVID-19 detection.
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
July 3, 2020
End Date
January 30, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Scentech Medical Technologies Ltd
Responsible Party
Sponsor

Eligibility 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

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

Outcomes

Primary Outcomes

Correlation between Volatile Organic Compounds pattern in-breath biopsy and COVID-19 detection.

Time Frame: Through the study completion, up to 3 months.

Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection in a swab test.

Secondary Outcomes

  • Correlation between Volatile Organic Compounds pattern and the course of the disease(Through the study completion, up to 3 months.)

Study Sites (2)

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