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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: 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).

Recruiting Locations

Anschutz Medical Campus
Aurora 5412347, Colorado 5417618 80045
Contact:
Brian Montague, DO
Brian.Montague@cuanschutz.edu

University of Colorado, Boulder
Boulder 5574991, Colorado 5417618 80309
Contact:
Leisha Conners Bauer, MPA
Leisha.ConnersBauer@Colorado.EDU

University of Colorado, Colorado Springs
Colorado Springs 5417598, Colorado 5417618 80918
Contact:
Stephanie Hanenberg, MSN
719-255-4444
shanenbe@uccs.edu

Denver Health
Denver 5419384, Colorado 5417618 80204
Contact:
Kellie Hawkins, MD
Kellie.Hawkins@dhha.org

Regis University
Denver 5419384, Colorado 5417618 80221
Contact:
Stephanie James, PhD
sjames001@regis.edu

Colorado State University
Fort Collins 5577147, Colorado 5417618 80523
Contact:
Jeannine Riess
970-491-6121

More Details

NCT ID
NCT05145803
Status
Unknown status
Sponsor
Colorado School of Public Health

Study Contact

Thomas Jaenisch, MD, PhD
720-626-1094
thomas.jaenisch@cuanschutz.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.