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

NCT04602871 | Completed

• 1 other identifier: Cov-2-2020
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

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

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

  Through the study completion, up to 3 months.

Secondary Outcomes (1)

• Correlation between Volatile Organic Compounds pattern and the course of the disease

  Through the study completion, up to 3 months.

Study Arms (2)

COVID 19 Positive patients

EXPERIMENTAL

Patients with COVID-19, qPCR for SARS-CoV-2 confirmed

Diagnostic Test: Breath Biopsy

Healthy subjects

OTHER

COVID-19 Negative subjects

Diagnostic Test: Breath Biopsy

Interventions

Breath Biopsy DIAGNOSTIC_TEST

Breath Biopsy sampling using the ReCIVA® Breath Sampler

COVID 19 Positive patients; Healthy subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• No history of COVID-19
• Capable of understanding written and/or spoken language
• Able to provide informed consent
• Was not treated with Anti-viral drugs
• Not a pregnant woman

You may not qualify if:

• 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

Sponsors & Collaborators

• Scentech Medical Technologies Ltd: lead

Study Sites (2)

Soroka Medical Center

Beersheba, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• David Shitrit, MD

  Meir Medical Center, Kfar Saba, Israel

  PRINCIPAL INVESTIGATOR

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: July 3, 2020
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: May 10, 2022

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)