COVID Breath Test - Ancon | NCT04760639

Studies
COVID Breath Test - Ancon

NCT04760639

Sponsor

Medical University of South Carolina

Status

Completed

Last Update Posted

Nov 14, 2022Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Covid19

Interventions

Breath test

Countries

United States

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 16, 2020Actual

Primary Completion Date

Sep 16, 2022Actual

Completion Date

Sep 20, 2022Actual

First Submitted Date

Feb 10, 2021

First Submission Date that Met QC Criteria

Feb 17, 2021

First Posted Date

Feb 18, 2021Actual

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 10, 2022

Last Update Posted Date

Nov 14, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gerard Silvestri, MD, Professor of Medicine, Medical University of South CarolinaPrincipal Investigator

Lead Sponsor

Medical University of South CarolinaOTHER

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

This study is designed to look at the effectiveness of a new technology call Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients. Participation in this study is expected to take less than one month and will consist of a breath sample being taken by the research team, a cheek swab being taken by the research team, a questionnaire that will be completed by the participant with the help of the research teams, and a review of your medical record.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group		Participants who have a positive Covid-19 Test or negative Covid-19 test who provide a breath sample.	Diagnostic Test: Breath test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breath test	Diagnostic Test	Participants provide a breath sample	Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Provide an adequate sample and compare the signals given from the two groups.	The samples from the participants will be analyzed to identify the different signals given from Covid-19 positive patients and Covid-19 negative patients	10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years and older
Patients that present for COVID-19 testing, have tested Covid negative, or Covid Positive patients.

Exclusion Criteria:

Unable to consent
Patients on a ventilator
Pregnant Women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population will consist of particpants who are receiving Covid-19 testing, as well as in-patient and out-patients with Covid-19.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of South Carolina		Charleston	South Carolina	29425	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

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

Intervention Browse Module

MeSH Terms

ID	Term
D001944	Breath Tests

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided