Detection of COVID-19 Using Breath Analysis - Validation Study

NCT ID: NCT04602949

Last Updated: 2023-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2558 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-12

Study Completion Date

2023-01-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COVID-19 patients

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

Group Type EXPERIMENTAL

Breath Biopsy Analysis

Intervention Type DIAGNOSTIC_TEST

Analysis of a single breath Biopsy

Healthy controls

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

Group Type OTHER

Breath Biopsy Analysis

Intervention Type DIAGNOSTIC_TEST

Analysis of a single breath Biopsy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Breath Biopsy Analysis

Analysis of a single breath Biopsy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Scentech Medical Technologies Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Natalie Dror, PhD

Role: STUDY_DIRECTOR

Scentech Medical Technologies Ltd

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shamir Medical Center

Be’er Ya‘aqov, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Cov-2-SMC-2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Covid-19 Breath Test
NCT04459962 COMPLETED NA
Baricitinib Therapy in COVID-19
NCT04358614 COMPLETED PHASE2/PHASE3
Screening for COVID-19
NCT04615208 WITHDRAWN