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

November 22, 2022 updated by: Dr. Guillermo Rodríguez Gómez, Instituto Costarricense de Investigaciones Clínicas ICIC
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

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

Study Locations

  • Costa Rica
      • San José, Costa Rica
        • Instituto Costarricense de Investigaciones Clínicas

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

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population under Country's screening program and known positive cases.

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Positive TeraSystem test
Patients having positive PCR tests will undergo TeraSystem test
Diagnostic test: Breath sample
Patient will blow into a tube 5 times.
Negative TeraSystem test
Patients having negative PCR tests will undergo TeraSystem test
Diagnostic test: Breath sample
Patient will blow into a tube 5 times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of disease
Time Frame: 1 minute
Established diagnosis
1 minute

Collaborators and Investigators

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

Sponsor

Instituto Costarricense de Investigaciones Clínicas ICIC

Investigators

  • Principal Investigator: Guillermo Rodríguez Gómez, MD, Founder and Investigator

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 (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

August 2, 2020

First Submitted That Met QC Criteria

August 2, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Actual)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tera-CR-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Personal data will be coded. No identifying information will be shared. Only demographic, and breath tests results will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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