Asymptomatic and Pre-symptomatic Transmission of SARS-CoV-2 in a Community Congregant Setting
NCT ID: NCT05145803
Last Updated: 2021-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
3300 participants
OBSERVATIONAL
2021-03-15
2022-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Individuals age ≥ 18 years and known to be contacts of the index patients \[CONTACTS\]
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Colorado State University
OTHER
University of Colorado, Boulder
OTHER
Colorado Mesa University
OTHER
Regis University
OTHER
Denver Health Medical Center
OTHER
University of Colorado, Colorado Springs
OTHER
University of Colorado, Denver
OTHER
Colorado School of Public Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Thomas Jaenisch
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Geoffrey Winstanley, PharmD
Role: STUDY_DIRECTOR
Colorado School of Public Health
Molly Lamb, PhD
Role: PRINCIPAL_INVESTIGATOR
Colorado School of Public Health
May Chu, PhD
Role: PRINCIPAL_INVESTIGATOR
Colorado School of Public Health
Thomas Jaenisch, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Colorado School of Public Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anschutz Medical Campus
Aurora, Colorado, United States
University of Colorado, Boulder
Boulder, Colorado, United States
University of Colorado, Colorado Springs
Colorado Springs, Colorado, United States
Denver Health
Denver, Colorado, United States
Regis University
Denver, Colorado, United States
Colorado State University
Fort Collins, Colorado, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Brian Montague, DO
Role: primary
Leisha Conners Bauer, MPA
Role: primary
Stephanie Hanenberg, MSN
Role: primary
Kellie Hawkins, MD
Role: primary
Stephanie James, PhD
Role: primary
Jeannine Riess
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Jaenisch T, Lamb MM, Gallichotte EN, Adams B, Henry C, Riess J, van Sickle JT, Hawkins KL, Montague BT, Coburn C, Conners Bauer L, Kovarik J, Hernandez MT, Bronson A, Graham L, James S, Hanenberg S, Kovacs J, Spencer JS, Zabel M, Fox PD, Pluss O, Windsor W, Winstanley G, Olson D, Barer M, Berman S, Ebel G, Chu M. Investigating transmission of SARS-CoV-2 using novel face mask sampling: a protocol for an observational prospective study of index cases and their contacts in a congregate setting. BMJ Open. 2022 Nov 23;12(11):e061029. doi: 10.1136/bmjopen-2022-061029.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21-2823
Identifier Type: -
Identifier Source: org_study_id