Breath Samples Collection Clinical Trial, for Development of the TERA BioStation T101, Intended for CoV-19 Exhalation Products Detection.

NCT05162495 | Unknown

• 1 other identifier: TERA-COV-02
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Sponsor has developed a rapid screening tool intended to determine if the subject tested has COVID-19.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  Rate of positive and negative cases in collected breath samples using breath analyzer test compare to PCR results.

  The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample

Study Arms (2)

Arm A

EXPERIMENTAL

Requiring a diagnostic or screening RT-PCR test for COVID-19.

Device: BioStation T101 and TeraTube

Arm B

EXPERIMENTAL

Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening.

Device: BioStation T101 and TeraTube

Interventions

BioStation T101 and TeraTube DEVICE

Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General:
• Male or female subject aged 18 years and above
• Subject is able and willing to provide informed consent
• Subject is able to complete the breath test.
• Arm A:
• Requiring a diagnostic or screening RT-PCR test for COVID-19.
• Arm B:
• Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening.

You may not qualify if:

• Male of female subject under the age of 18.
• Subject is unable to provide and informed consent, for any reason.

Sponsors & Collaborators

• Tera Group: lead

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

Central Study Contacts

Yebgeny Marzon, MD

CONTACT

+972 50 764 3281; emarzon@leumit.co.il

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

Model Details: The participant's breath sample is taken by blowing preferably three times into a disposable TeraTube. Thereafter, the tube is sealed, sterilized, and scanned by the BioSafety Station for analysis of its bio-chemical spectral signature. This will take place once during the study.

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: December 17, 2021
• Study Start: January 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: January 11, 2022

Record last verified: 2021-12