Validation of TERA Bio Station T101 of COVID-19 Tested Population.

NCT05088902 | Unknown

• 1 other identifier: Validation of TERA Bio Station
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

TERABio Ltd. has developed a rapid screening tool intended to determine if a tested individual is COVID-19-free (Negative to COVID-19).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Clearing at least 80% of the healthy population

  TERABio Ltd. has developed a rapid screening tool intended to determine if a tested individual is COVID-19-free (Negative to COVID-19). The goal of the pilot is to perform a localized validation to the TERA Bio Tests by TERA Bio Station(s)- Success Criteria -Clearing at least 80% of the healthy population.

  7 Weeks (Estimated)

Interventions

TERABio Ltd. DIAGNOSTIC_TEST

Covid- 19 investigational breath test compared to RT- PCR test. TERABio Ltd. has developed a rapid screening tool intended to determine if a tested individual is COVID-19-free (Negative to COVID-19 ).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Research Population Requirements: * Male and Female, age ≥ 18 years old, whose COVID-19 virus infection status is known and verified for at least the last 24 hours (prior to the TERA.Bio test). * The study will include a minimum of 300 tested Positive individuals and a minimum of 700 Negative individuals, tested during the 24 hours prior to the TERA.Bio test. * Additional PCR tests on specific individuals, based on their symptomatic status and/or their PCR's CT value may be required be done 3 days after taking the breath test. * It is expected that each day will contain both Positive and Negative individuals in a similar ratio to the overall expected one (30%)

You may qualify if:

• Age ≥ 18 years old (under 18 years old - only if it is allowed under local regulations and with legal guardian's approval and consent if needed.
• COVID-19 virus infection status is known and verified 24 hours prior to a TERA.Bio test by RT-PCR and if required, a repeated PCR test based on symptomatic status and or / the CT value of the tested individual.
• Signed Informed consent form.

You may not qualify if:

• Individuals under general anaesthesia
• Individuals lacking the capability to personally sign the consent form.
• Individuals lacking the capability to exhale breath.

Sponsors & Collaborators

• Tera Group: lead

Study Sites (1)

TR Ministry of Health Istanbul Provincial Health Directorate Kartal Dr. Lütfi Kirdar City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

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

• Nihat Müjdat Hökenek, MD

  TR Ministry of Health Istanbul Provincial Health Directorate Kartal Dr. Lütfi Kirdar City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nihat Müjdat Hökenek, MD

CONTACT

+90 555 320 14 19; nihathokenek@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: October 22, 2021
• Study Start: October 22, 2021
• Primary Completion: March 6, 2022
• Study Completion: June 30, 2022
• Last Updated: December 21, 2021

Record last verified: 2021-10

Locations

TU (1)