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

NCT04497610 | Withdrawn

• 1 other identifier: Tera-CR-1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID19

Keywords

SARS-CoV-2, coronavirus testing

Outcome Measures

Primary Outcomes (1)

• Presence of disease

  Established diagnosis

  1 minute

Study Arms (2)

Positive TeraSystem test

Patients having positive PCR tests will undergo TeraSystem test

Diagnostic Test: Breath sample

Negative TeraSystem test

Patients having negative PCR tests will undergo TeraSystem test

Diagnostic Test: Breath sample

Interventions

Breath sample DIAGNOSTIC_TEST

Patient will blow into a tube 5 times.

Negative TeraSystem test; Positive TeraSystem test

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Younger than 7 years of age Unable to provide informed consent Unable to take the breath test

Sponsors & Collaborators

• Instituto Costarricense de Investigaciones Clínicas ICIC: lead

Study Sites (1)

Instituto Costarricense de Investigaciones Clínicas

San José, Costa Rica

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

breath sample

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Guillermo Rodríguez Gómez, MD

  Founder and Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founder

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 4, 2020
• Study Start: November 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)