COVID19NCT04497610
SARS-CoV-2 (COVID-19) Detection Using the Breath Analizer TeraSystem
An observational study of COVID19, run by Instituto Costarricense de Investigaciones Clínicas ICIC at 1 site in Costa Rica.
Trial summary
The purpose of the study is to verify the sensibility and accuracy of a rapid detection test for SARS-CoV-2 in breath samples analyzed by the breath detector analyzer TeraSystem, comparing with PCR tests. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID19
- What is being tested?
- Breath sample
- How many people
- 0 participants
- Where
- 1 siteCosta Rica
- Study dates
- Nov 2022to Nov 2022
- How long will I take part?
- 1 Day
- 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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Population under Country's screening program and known positive cases.
Who may be able to join
- Older than 7 years odf age Able to provide informed consent Able to take the breath test
Who cannot join
- Younger than 7 years of age Unable to provide informed consent Unable to take the breath test
Trial locations and contacts
1 site in 1 country.
Costa Rica1 site
Instituto Costarricense de Investigaciones Clínicas
San José
About this study
The purpose of the study is to verify the sensibility and accuracy of a rapid detection test for SARS-CoV-2 in breath samples analyzed by the breath detector analyzer TeraSystem, comparing with PCR tests.
Read the detailed description
BioSafety Technologies has developed a rapid detection test to clear people of COVID-19.
A person can undergo an easy non-invasive test, to determine if they are: COVID-19 Clear (Negative) or Infected (Positive). The user-friendly process does not involve medically trained personnel.
The study will compare TeraSystem test results against PCR test results. Persons participating will be persons having a PCR test as part of the Health System and consenting to participate.
- Conditions
- COVID19
- Being tested
- Breath sample
- Keywords
- SARS-CoV-2, coronavirus testing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath sampleDiagnostic test
Patient will blow into a tube 5 times.
| Study group | Role | What they receive |
|---|---|---|
| Positive TeraSystem test | Patients having positive PCR tests will undergo TeraSystem test Receives: Diagnostic Test: Breath sample | |
| Negative TeraSystem test | Patients having negative PCR tests will undergo TeraSystem test Receives: Diagnostic Test: Breath sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of disease
Established diagnosis
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study startNov 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Why it stopped: Study was not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies 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
- 0 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Instituto Costarricense de Investigaciones Clínicas ICIC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Guillermo Rodríguez Gómez, Instituto Costarricense de Investigaciones Clínicas ICIC
- Investigators
- Guillermo Rodríguez Gómez, MD, Principal investigator, Founder and Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497610
- Sponsor's protocol ID
- Tera-CR-1
- Status last verified
- Nov 2022
- First submitted
- 2 Aug 2020
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal data will be coded. No identifying information will be shared. Only demographic, and breath tests results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 (COVID-19) Detection Using the Breath Analizer TeraSystem
- ClinicalTrials.gov ID
- NCT04497610
- Acronym / sponsor ID
- Tera-CR-1
- Conditions
- COVID19
- Keywords
- SARS-CoV-2, coronavirus testing
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Instituto Costarricense de Investigaciones Clínicas ICICUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 4 Aug 2020 (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.
The purpose of the study is to verify the sensibility and accuracy of a rapid detection test for SARS-CoV-2 in breath samples analyzed by the breath detector analyzer TeraSystem, comparing with PCR tests.
Detailed description
BioSafety Technologies has developed a rapid detection test to clear people of COVID-19.
A person can undergo an easy non-invasive test, to determine if they are: COVID-19 Clear (Negative) or Infected (Positive). The user-friendly process does not involve medically trained personnel.
The study will compare TeraSystem test results against PCR test results. Persons participating will be persons having a PCR test as part of the Health System and consenting to participate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive TeraSystem test | – | Diagnostic Test: Breath samplePatients having positive PCR tests will undergo TeraSystem test |
| Negative TeraSystem test | – | Diagnostic Test: Breath samplePatients having negative PCR tests will undergo TeraSystem test |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population under Country's screening program and known positive cases.
Key inclusion criteria (1 listed)
- Older than 7 years odf age Able to provide informed consent Able to take the breath test
Key exclusion criteria (1 listed)
- Younger than 7 years of age Unable to provide informed consent Unable to take the breath test
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 |
|---|---|---|
| Breath samplePatient will blow into a tube 5 times. | Diagnostic test | Negative TeraSystem test, Positive TeraSystem test |
Primary outcome
Presence of disease
Time frame: 1 minute
Established diagnosis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Individual participant dataSharing planned: No. Personal data will be coded. No identifying information will be shared. Only demographic, and breath tests results will be shared.
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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.
Guillermo Rodríguez Gómez, MD principal investigator
Founder and Investigator
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 COVID19, run by Instituto Costarricense de Investigaciones Clínicas ICIC at 1 site in Costa Rica.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 29 Nov 2022. 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 Costa Rica. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of disease (time frame: 1 minute). 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 29 Nov 2022.