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

• Conditions: COVID-19; SARS-CoV2 Infection
• Interventions: Device: Polyvinylalcohol strip [diagnostic]

• Registration Number: NCT05145803
• Lead Sponsor: Colorado School of Public Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-15
• Status Verified: 2021-12
• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-06
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-20
• Primary Completion: 2022-03-09
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
College Students	Polyvinylalcohol strip [diagnostic]	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.

Primary Outcome Measures

Name	Time	Method
PVA strip positivity	72 hours after sample collection

Trial Locations

Locations (6)

Denver Health; 🇺🇸 Denver, Colorado, United States

Regis University; 🇺🇸 Denver, Colorado, United States

University of Colorado, Colorado Springs; 🇺🇸 Colorado Springs, Colorado, United States

Colorado State University; 🇺🇸 Fort Collins, Colorado, United States

Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

University of Colorado, Boulder; 🇺🇸 Boulder, Colorado, United States