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

Sponsor
Instituto Costarricense de Investigaciones Clínicas ICIC (Other)
Overall Status
Unknown status
CT.gov ID
NCT04497610
Collaborator
(none)
1,000
Enrollment
1
Location
11
Anticipated Duration (Days)
2767
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Breath sample

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
SARS-CoV-2 (COVID-19) Detection Using the Breath Analizer TeraSystem
Anticipated Study Start Date :
Aug 4, 2020
Anticipated Primary Completion Date :
Aug 15, 2020
Anticipated Study Completion Date :
Aug 15, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Presence of disease [1 minute]

    Established diagnosis

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto Costarricense de Investigaciones Clínicas San José Costa Rica

Sponsors and Collaborators

  • Instituto Costarricense de Investigaciones Clínicas ICIC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Guillermo Rodríguez Gómez, Founder, Instituto Costarricense de Investigaciones Clínicas ICIC
ClinicalTrials.gov Identifier:
NCT04497610
Other Study ID Numbers:
  • Tera-CR-1
First Posted:
Aug 4, 2020
Last Update Posted:
Aug 4, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Guillermo Rodríguez Gómez, Founder, Instituto Costarricense de Investigaciones Clínicas ICIC
SARS-CoV-2, coronavirus testing
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Aug 4, 2020