TERABio Ltd. in COVID-19 - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

COVID-19

Intervention / Treatment

Diagnostic test: TERABio Ltd.

Detailed Description

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.

Pilot duration: approx. 6-10 work weeks long.

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%).

Test Procedure:

A staff member will explain to the tested individual about the test and will hand him an informed consent form. The tested individual will review and sign the consent form and return it to the staff member. The individual must sign the informed consent form in order to participate in the pilot testing. The individual's breath sample is then taken by blowing three times into a disposable TERATube. Thereafter, the tube is sealed, sterilized, and scanned by the TERA Bio Station for analysis of its bio-chemical spectral signature.

Blind Test objectives and method:

Following data analytics of the previous phase and once achieving sufficient testing, a blind test may be performed to validate the accuracy of the TERA.Bio test. The blind test will include 60 individuals from which 30 must be Positive for COVID-19.

The blind test's tested individuals will be tested in the exact way the pilot testing was performed and with RT-PCR with the exact same CT.

TERA.Bio's team will conduct the breath tests scanning and decoding procedure without obtaining the RT-PCR results in-advance.

The TERA.Bio team will send predictions for each tested individual (suspected\negative) to the pilot manager and primary investigator after ALL pilot participants have been tested.

The RT-PCR results will then be sent to the TERA.Bio team. The two parties will compare the results obtained from the TERA Bio Station to the results from the RT-PCR.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Nihat Müjdat Hökenek, MD
Phone Number: +90 555 320 14 19
Email: nihathokenek@gmail.com

Study Locations

Turkey
- - Istanbul, Turkey
    - Recruiting
    - TR Ministry of Health Istanbul Provincial Health Directorate Kartal Dr. Lütfi Kirdar City Hospital
    - Contact:
      
      Nihat Müjdat Hökenek, MD
      
      Phone Number: +90 5553201419
      
      Email: nihathokenek@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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%)

Description

Inclusion Criteria:

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.

Exclusion Criteria:

Discrepancies to inclusion criteria
Individuals under general anaesthesia
Individuals lacking the capability to personally sign the consent form.
Individuals lacking the capability to exhale breath.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clearing at least 80% of the healthy population Time Frame: 7 Weeks (Estimated)	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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tera Group

Investigators

Principal Investigator: Nihat Müjdat Hökenek, MD, TR Ministry of Health Istanbul Provincial Health Directorate Kartal Dr. Lütfi Kirdar City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2021

Primary Completion (Anticipated)

March 6, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)