COVID Breath Test - Ancon

Breath Test Feasibility Trial for COVID-19 Infection Diagnosis

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Breath test

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Test group; Participants who have a positive Covid-19 Test or negative Covid-19 test who provide a breath sample.	Diagnostic test: Breath test; Participants provide a breath sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Actual): September 16, 2022
• Study Completion (Actual): September 20, 2022

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Pro00102970

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No