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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05145803
• Other study ID #: 21-2823
• Status: Recruiting
• Start date: March 15, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: December 2021
• Source: Colorado School of Public Health
• Contact: Thomas Jaenisch, MD, PhD
• Phone: 720-626-1094
• Email: thomas.jaenisch[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3300
• Est. completion date: September 1, 2022
• Est. primary completion date: March 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19
• Infections
• SARS-CoV2 Infection

Intervention

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).

Locations

Country	Name	City	State
United States	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

Sponsors (8)

Lead Sponsor	Collaborator
Colorado School of Public Health	Colorado Mesa University, Colorado State University, Denver Health Medical Center, Regis University, University of Colorado, Boulder, University of Colorado, Colorado Springs, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PVA strip positivity		72 hours after sample collection