Recruiting

Observational Study

Sponsor:

Colorado School of Public Health

Code:

NCT05145803

Conditions

COVID-19

SARS-CoV2 Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Polyvinylalcohol strip [diagnostic]

Study Details

Brief summary:

The overall aim of this study is to measure how transmission of COVID-19 occurs in communities - including the role of super spreaders and/or identifying conditions that may increase transmission risk, with a focus on congregant situations. In order to identify how presence of symptoms and behavior affects the transmissibility of the virus, the investigators will measure SARS-CoV-2 in exhaled breath of asymptomatic and symptomatic persons using polyvinyl alcohol (PVA) test strips embedded in face masks (Face Mask Sampling- "FMS") - an innovative, non-invasive method for detection of SARS-CoV-2 in exhaled air.

Conditions

COVID-19

SARS-CoV2 Infection

Study ID

NCT05145803

Start date

Mar 15, 2021

Status verified date

Dec, 2021

Completion date

Sep 1, 2022

Anticipated

Primary completion date

Mar 9, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Individuals age ≥ 18 years of any gender tested positive for SARS-CoV-2 by a molecular reference test (PCR test or antigen test) \[INDEX PATIENTS\]
  • Individuals age ≥ 18 years and known to be contacts of the index patients \[CONTACTS\]

Exclusion Criteria:

  • < age 18 years old, unable to wear a face mask due to underlying condition, not able to consent, pregnancy. In addition, signs of severe disease present at time of enrollment (e.g. difficulty breathing, pain when breathing, tightness of chest or developing irregular heart beat).

Study Design

Enrollment

3300 participants

Anticipated

Interventions and Outcome Measures

Arms

College Students

Collegiate students tested positive for SARS-CoV-2 by a molecular reference test (PCR test or antigen test) (index patients).

Collegiate students known to be contacts of the index patients.

Interventions

Polyvinylalcohol strip [diagnostic]

The investigators will measure SARS-CoV-2 in exhaled breath of asymptomatic and symptomatic persons using PVA test strips embedded in face masks (FMS) - an innovative, non-invasive method for detection of SARS-CoV-2 in exhaled air. Utilizing this approach, the study aims to utilize the test results extracted from the masks to identify risk factors for SARS-CoV-2 transmission and timing of infectious period in exposed people (pre-symptomatic, asymptomatic, and symptomatic).

Primary outcome measure

  • PVA strip positivity [ Time Frame: 72 hours after sample collection ]

Central Contacts and Locations

Central contacts

Thomas Jaenisch, MD, PhD

720-626-1094thomas.jaenisch@cuanschutz.edu

May Chu, PhD

may.chu@cuanschutz.edu

Locations

Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Brian Montague, DO

Brian.Montague@cuanschutz.edu

Principal Investigator:

Brian Montague, DO

University of Colorado, Boulder

Recruiting

Boulder, Colorado, United States, 80309

Contacts

Leisha Conners Bauer, MPA

Leisha.ConnersBauer@Colorado.EDU

Principal Investigator:

Leisha Conners Bauer, MPA

University of Colorado, Colorado Springs

Recruiting

Colorado Springs, Colorado, United States, 80918

Contacts

Stephanie Hanenberg, MSN

719-255-4444shanenbe@uccs.edu

Principal Investigator:

Stephanie Hanenberg, MSN

Denver Health

Recruiting

Denver, Colorado, United States, 80204

Contacts

Kellie Hawkins, MD

Kellie.Hawkins@dhha.org

Principal Investigator:

Kellie Hawkins, MD

Regis University

Recruiting

Denver, Colorado, United States, 80221

Contacts

Stephanie James, PhD

sjames001@regis.edu

Principal Investigator:

Stephanie James, PhD

Colorado State University

Recruiting

Fort Collins, Colorado, United States, 80523

Contacts

Jeannine Riess

970-491-6121

Principal Investigator:

Joni T van Sickle, BS

More Information

Sponsor

Colorado School of Public Health

Last update posted

Dec 20, 2021

Last verified

Dec, 2021

Keywords

  • COVID-19 Transmission
  • SARS-CoV2 Transmission

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colorado School of Public Health on 2021-12-20.