SARS-CoV-2 (COVID-19) Detection Using the Breath Analizer... | NCT04497610

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

NCT04497610

Sponsor

Instituto Costarricense de Investigaciones Clínicas ICIC

Status

Withdrawn

Last Update Posted

Nov 29, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

COVID19

Interventions

Breath sample

Countries

Costa Rica

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was not initiated

Expanded Access Info

Start Date

Nov 2022Estimated

Primary Completion Date

Nov 2022Estimated

Completion Date

Nov 2022Estimated

First Submitted Date

Aug 2, 2020

First Submission Date that Met QC Criteria

Aug 2, 2020

First Posted Date

Aug 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2022

Last Update Posted Date

Nov 29, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Guillermo Rodríguez Gómez, Founder, Instituto Costarricense de Investigaciones Clínicas ICICPrincipal Investigator

Lead Sponsor

Instituto Costarricense de Investigaciones Clínicas ICICOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Breath sample	Diagnostic Test	Patient will blow into a tube 5 times.	Negative TeraSystem test Positive TeraSystem test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of disease	Established diagnosis	1 minute

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guillermo Rodríguez Gómez, MD	Founder and Investigator	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Costarricense de Investigaciones Clínicas		San José			Costa Rica

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided