NCT05224622

Brief Summary

Detection of the 2019 novel Coronavirus (SARS-CoV-2) using breath analysis - Validation study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
Last Updated

May 31, 2023

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

February 3, 2022

Last Update Submit

May 28, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Presence of Volatile Organic Compounds indicating carriers of COVID-19.

    Obtain early verification accuracy of measures for a set of VOCs biomarkers indicating carriers of Corona virus.

    Through the study completion, up to 3 months.

Secondary Outcomes (1)

  • Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.)

    Through the study completion, up to 3 months.

Study Arms (3)

Drive In

EXPERIMENTAL

Drive In attendees will undergo one breath sampling.

Diagnostic Test: VOX

Healthy

EXPERIMENTAL

Healthy attendees will undergo two successive breath sampling.

Diagnostic Test: VOX

Corona Department

EXPERIMENTAL

Healthy attendees will undergo five successive breath sampling.

Diagnostic Test: VOX

Interventions

VOXDIAGNOSTIC_TEST

Breath exhalation into the mouthpiece of the VOX breath diagnostic device.

Corona DepartmentDrive InHealthy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 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

You may not qualify if:

  • Age under 18 years old
  • Under guardianship or deprived of liberty
  • Pregnant or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poriya Medical Center

Poria – Neve Oved, 1528001, Israel

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Avi Peretz, PhD

    Poriya Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2022

First Posted

February 4, 2022

Study Start

January 18, 2022

Primary Completion

May 28, 2022

Study Completion

January 18, 2023

Last Updated

May 31, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

No IPD

Locations

IL(1)