Asymptomatic and Pre-symptomatic Transmission of SARS-CoV-2 in a Community Congregant Setting

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; SARS-CoV2 Infection
• Intervention / Treatment: Device: Polyvinylalcohol strip [diagnostic]

• Study Type: Observational
• Enrollment (Anticipated): 3300

Contacts and Locations

• Study Contact: Name: Thomas Jaenisch, MD, PhD; Phone Number: 720-626-1094; Email: thomas.jaenisch@cuanschutz.edu
• Study Contact Backup: Name: May Chu, PhD; Email: may.chu@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Anschutz Medical Campus
      • Contact: Brian Montague, DO; Email: Brian.Montague@cuanschutz.edu
      • Principal Investigator: Brian Montague, DO
    • Boulder, Colorado, United States, 80309
      • Recruiting
      • University of Colorado, Boulder
      • Contact: Leisha Conners Bauer, MPA; Email: Leisha.ConnersBauer@Colorado.EDU
      • Principal Investigator: Leisha Conners Bauer, MPA
      • Principal Investigator: Gloria Brisson, MSN
    • Colorado Springs, Colorado, United States, 80918
      • Recruiting
      • University of Colorado, Colorado Springs
      • Contact: Stephanie Hanenberg, MSN; Phone Number: 719-255-4444; Email: shanenbe@uccs.edu
      • Principal Investigator: Stephanie Hanenberg, MSN
    • Denver, Colorado, United States, 80204
      • Recruiting
      • Denver Health
      • Contact: Kellie Hawkins, MD; Email: Kellie.Hawkins@dhha.org
      • Principal Investigator: Kellie Hawkins, MD
    • Denver, Colorado, United States, 80221
      • Recruiting
      • Regis University
      • Contact: Stephanie James, PhD; Email: sjames001@regis.edu
      • Principal Investigator: Stephanie James, PhD
    • Fort Collins, Colorado, United States, 80523
      • Recruiting
      • Colorado State University
      • Contact: Jeannine Riess; Phone Number: 970-491-6121
      • Principal Investigator: Joni T van Sickle, BS
      • Principal Investigator: Jeannine Riess, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Students 18 years and older

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PVA strip positivity	72 hours after sample collection

Collaborators and Investigators

• Sponsor: Colorado School of Public Health
• Collaborators: University of Colorado, Denver; University of Colorado, Boulder; Colorado State University; University of Colorado, Colorado Springs; Regis University; Denver Health Medical Center; Colorado Mesa University
• Investigators: Study Director: Geoffrey Winstanley, PharmD, Colorado School of Public Health; Principal Investigator: Molly Lamb, PhD, Colorado School of Public Health; Principal Investigator: May Chu, PhD, Colorado School of Public Health; Principal Investigator: Thomas Jaenisch, MD, PhD, Colorado School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Anticipated): March 9, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): December 20, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19 Transmission; SARS-CoV2 Transmission
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections
• Other Study ID Numbers: 21-2823

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No