Clinical trial NCT05145803: Asymptomatic and Pre-symptomatic Transmission of SARS-CoV-2 in a Community Congregant Setting
Official title: Asymptomatic and Pre-symptomatic Transmission of SARS-CoV-2 in a Community Congregant Setting: a Study to Understand How Infection Control Practices Can Mitigate Exposure Risks
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
SARS-CoV2 Infection
Keywords: COVID-19 Transmission
SARS-CoV2 Transmission
Lead sponsor: Colorado School of Public Health
Sponsor class: OTHER
Collaborators: name: Colorado State University
name: University of Colorado, Boulder
name: Colorado Mesa University
name: Regis University
name: Denver Health Medical Center
name: University of Colorado, Colorado Springs
name: University of Colorado, Denver
First posted: 2021-12-06
Enrollment: 3300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Students 18 years and older

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.


Eligibility criteria: 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).

Primary outcomes:
measure: PVA strip positivity
timeFrame: 72 hours after sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Anschutz Medical Campus
state: Colorado
city: Boulder
country: United States
facility: University of Colorado, Boulder
state: Colorado
city: Colorado Springs
country: United States
facility: University of Colorado, Colorado Springs
state: Colorado
city: Denver
country: United States
facility: Denver Health
state: Colorado
city: Denver
country: United States
facility: Regis University
state: Colorado
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
affiliation: Colorado School of Public Health
name: Geoffrey Winstanley, PharmD
role: STUDY_DIRECTOR
affiliation: Colorado School of Public Health
name: Molly Lamb, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Colorado School of Public Health
name: May Chu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Colorado School of Public Health
name: Thomas Jaenisch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: