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

COVID-19 Clinical Trial

Official title:

Pilot Testing Manual For Validation Purposes Providing Clearance for COVID-19 Tested Individuals Using the TERA Bio Station T101

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05088902
• Other study ID #: Validation of TERA Bio Station
• Status: Recruiting
• Start date: October 22, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2021
• Source: Tera Group
• Contact: Nihat Müjdat Hökenek, MD
• Phone: +90 555 320 14 19
• Email: nihathokenek[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2022
• Est. primary completion date: March 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. 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.

3. Signed Informed consent form.

Exclusion Criteria:

1. Discrepancies to inclusion criteria

2. Individuals under general anaesthesia

3. Individuals lacking the capability to personally sign the consent form.

4. Individuals lacking the capability to exhale breath.

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• TERABio Ltd.
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 ).

Locations

Country	Name	City	State
Turkey	TR Ministry of Health Istanbul Provincial Health Directorate Kartal Dr. Lütfi Kirdar City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Tera Group

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)