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

University of Colorado

Status: Unknown

Conditions: COVID-19; SARS-CoV2 Infection

Treatments: Device: Polyvinylalcohol strip [diagnostic]

Study type: Observational

Funder types: Other

Identifiers

NCT05145803

21-2823

Details and patient eligibility

About

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.

Enrollment: 3,300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

3,300 participants in 1 patient group

College Students

Description:

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.

Treatment:

Device: Polyvinylalcohol strip [diagnostic]