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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05145803

Enrollment

3300

Registered

2021-12-06

Start date

2021-03-15

Completion date

2022-09-01

Last updated

2021-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, SARS-CoV2 Infection

Keywords

COVID-19 Transmission, SARS-CoV2 Transmission

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.

Interventions

DEVICEPolyvinylalcohol 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).

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame
PVA strip positivity	72 hours after sample collection

Countries

United States

Contacts

Primary ContactThomas Jaenisch, MD, PhD

thomas.jaenisch@cuanschutz.edu720-626-1094

Backup ContactMay Chu, PhD

may.chu@cuanschutz.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026