COVID-19NCT05088902
Validation of TERA Bio Station T101 of COVID-19 Tested Population.
An observational study of COVID-19, run by Tera Group at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- TERABio Ltd.
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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%)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
TR Ministry of Health Istanbul Provincial Health Directorate Kartal Dr. Lütfi Kirdar City Hospital
Istanbul
Nihat Müjdat Hökenek, MD, +90 5553201419, nihathokenek@gmail.com
About this study
Official title: Pilot Testing Manual For Validation Purposes Providing Clearance for COVID-19 Tested Individuals Using the TERA Bio Station T101
TERABio Ltd. has developed a rapid screening tool intended to determine if a tested individual is COVID-19-free (Negative to COVID-19).
Read the 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.
- Conditions
- COVID-19
- Being tested
- TERABio Ltd.
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 Weeks (Estimated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start22 Oct 2021
- Primary completion6 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tera Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nihat Müjdat Hökenek, MD, Principal investigator, TR Ministry of Health Istanbul Provincial Health Directorate Kartal Dr. Lütfi Kirdar City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088902
- Sponsor's protocol ID
- Validation of TERA Bio Station
- Status last verified
- Oct 2021
- First submitted
- 21 Oct 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing Manual For Validation Purposes Providing Clearance for COVID-19 Tested Individuals Using the TERA Bio Station T101
- ClinicalTrials.gov ID
- NCT05088902
- Acronym / sponsor ID
- Validation of TERA Bio Station
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tera GroupIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 6 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TERABio Ltd. has developed a rapid screening tool intended to determine if a tested individual is COVID-19-free (Negative to COVID-19).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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%)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 ). | Diagnostic test | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nihat Müjdat Hökenek, MD principal investigator
TR Ministry of Health Istanbul Provincial Health Directorate Kartal Dr. Lütfi Kirdar City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Tera Group at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nihat Müjdat Hökenek, MD (+90 555 320 14 19, nihathokenek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearing at least 80% of the healthy population (time frame: 7 Weeks (Estimated)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.