NCT04602949

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
2,558

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Nov 2020

Longer than P75 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

First Submitted

Initial submission to the registry

October 21, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

November 12, 2020

Completed
1.5 years 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 16, 2023

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

October 21, 2020

Last Update Submit

May 14, 2023

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

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

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

    Through the study completion, up to 3 months.

Secondary Outcomes (2)

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

    Through the study completion, up to 3 months.

  • sensitivity level of biomarkers' algorithm.

    Through the study completion, up to 3 months.

Study Arms (2)

COVID-19 patients

EXPERIMENTAL

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

Diagnostic Test: Breath Biopsy Analysis

Healthy controls

OTHER

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

Diagnostic Test: Breath Biopsy Analysis

Interventions

Breath Biopsy AnalysisDIAGNOSTIC_TEST

Analysis of a single breath Biopsy

COVID-19 patientsHealthy controls

Eligibility Criteria

Age6 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age under 6 years old
  • Under guardianship or deprived of liberty
  • Pregnant or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shamir Medical Center

Be’er Ya‘aqov, 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

  • Natalie Dror, PhD

    Scentech Medical Technologies Ltd

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 21, 2020

First Posted

October 26, 2020

Study Start

November 12, 2020

Primary Completion

May 28, 2022

Study Completion

January 18, 2023

Last Updated

May 16, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

No IPD is to be shared with other researchers.

Locations

IL(1)