NCT04760639

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

1.8 years

First QC Date

February 10, 2021

Last Update Submit

November 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Breath testDIAGNOSTIC_TEST

Participants provide a breath sample

Test group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Unable to consent
  • Patients on a ventilator
  • Pregnant Women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Breath Tests

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 18, 2021

Study Start

December 16, 2020

Primary Completion

September 16, 2022

Study Completion

September 20, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations