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

• Sponsor: Colorado School of Public Health (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05145803
• Collaborator: 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)
• Enrollment: 3,300
• Locations: 6
• Anticipated Duration (Months): 17.6
• Patients Per Site: 550
• Patients Per Site Per Month: 31.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; SARS-CoV2 Infection	Device: Polyvinylalcohol strip [diagnostic]

Study Design

• Study Type: Observational
• Anticipated Enrollment: 3300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Mar 15, 2021
• Anticipated Primary Completion Date: Mar 9, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm

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).

Outcome Measures

Primary Outcome Measures

1. PVA strip positivity [72 hours after sample collection]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anschutz Medical Campus	Aurora	Colorado	United States	80045
2	University of Colorado, Boulder	Boulder	Colorado	United States	80309
3	University of Colorado, Colorado Springs	Colorado Springs	Colorado	United States	80918
4	Denver Health	Denver	Colorado	United States	80204
5	Regis University	Denver	Colorado	United States	80221
6	Colorado State University	Fort Collins	Colorado	United States	80523

Sponsors and Collaborators

• Colorado School of Public Health
• Colorado State University
• University of Colorado, Boulder
• Colorado Mesa University
• Regis University
• Denver Health Medical Center
• University of Colorado, Colorado Springs
• University of Colorado, Denver

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Jaenisch, Associate Professor, Colorado School of Public Health
• ClinicalTrials.gov Identifier: NCT05145803
• Other Study ID Numbers: 21-2823
• First Posted: Dec 6, 2021
• Last Update Posted: Dec 20, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Thomas Jaenisch, Associate Professor, Colorado School of Public Health: COVID-19 Transmission; SARS-CoV2 Transmission
• Additional relevant MeSH terms: Infections; COVID-19

Study Results

No Results Posted as of Dec 20, 2021