SARS-CoV-2 (COVID-19) Detection Using the Breath Analizer TeraSystem

NCT ID: NCT04497610

Last Updated: 2022-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-30

Study Completion Date

2022-11-30

Brief Summary

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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

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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

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COVID19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Positive TeraSystem test

Patients having positive PCR tests will undergo TeraSystem test

Breath sample

Intervention Type DIAGNOSTIC_TEST

Patient will blow into a tube 5 times.

Negative TeraSystem test

Patients having negative PCR tests will undergo TeraSystem test

Breath sample

Intervention Type DIAGNOSTIC_TEST

Patient will blow into a tube 5 times.

Interventions

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Breath sample

Patient will blow into a tube 5 times.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Older than 7 years odf age Able to provide informed consent Able to take the breath test

Exclusion Criteria

Younger than 7 years of age Unable to provide informed consent Unable to take the breath test
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Costarricense de Investigaciones Clínicas ICIC

OTHER

Sponsor Role lead

Responsible Party

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Dr. Guillermo Rodríguez Gómez

Founder

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guillermo Rodríguez Gómez, MD

Role: PRINCIPAL_INVESTIGATOR

Founder and Investigator

Locations

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Instituto Costarricense de Investigaciones Clínicas

San José, , Costa Rica

Site Status

Countries

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Costa Rica

Other Identifiers

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Tera-CR-1

Identifier Type: -

Identifier Source: org_study_id

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