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Detection of COVID-19 Using Breath Analysis - Validation Study

Sponsor
Scentech Medical Technologies Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04602949
Collaborator
(none)
4,000
Enrollment
1
Location
2
Arms
30.5
Anticipated Duration (Months)
131.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Breath Biopsy Analysis
 N/A

Detailed Description

A diagnostic prospective single-site study, with no anticipated risks or constraints.

Primary objective- To validate the value of a set of breath VOC biomarkers that enable us to distinguish between Coronavirus (SARS-CoV-2) carriers and SARS-CoV-2-negative in comparison to the gold-standard testing methodology.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
4000 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Validation Study
Actual Study Start Date :
Nov 12, 2020
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
May 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: COVID-19 patients

subjects who were found as COVID-19 positive patients by swab RT-PCR

Diagnostic Test: Breath Biopsy Analysis
Analysis of a single breath Biopsy
Other: Healthy controls

subjects who were found as COVID-19 Negative, by swab RT-PCR

Diagnostic Test: Breath Biopsy Analysis
Analysis of a single breath Biopsy

Outcome Measures

Primary Outcome Measures

  1. Presence of Volatile Organic Compounds indicating carriers of COVID-19. [Through the study completion, up to 3 months.]

    Comparison of Volatile Organic Compounds found among COVID-19 carriers and Healthy controls.

Secondary Outcome Measures

  1. Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.). [Through the study completion, up to 3 months.]

    Correlation level between exhaled biomarkers and participants' demographic characteristics.

  2. sensitivity level of biomarkers' algorithm. [Through the study completion, up to 3 months.]

    comparison of algorithm's sensitivity level to the sensitivity of COVID-19 swab TEST.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Age 6 to 75 years at the time of consent

  • Capable of understanding written and/or spoken language

  • Able to provide informed consent

  • Was not treated with Anti-viral drugs

Exclusion Criteria:

  • Age under 6 years old

  • Under guardianship or deprived of liberty

  • Pregnant or lactating woman

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shamir Medical Center Be'er Ya'aqov Israel

Sponsors and Collaborators

  • Scentech Medical Technologies Ltd

Investigators

  • Study Director: Natalie Dror, PhD, Scentech Medical Technologies Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Scentech Medical Technologies Ltd
ClinicalTrials.gov Identifier:
NCT04602949
Other Study ID Numbers:
  • Cov-2-SMC-2020
First Posted:
Oct 26, 2020
Last Update Posted:
Aug 9, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Aug 9, 2022