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Clinical Trials/NCT05145803
NCT05145803UnknownNot Applicable

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

Colorado School of Public Health6 sites in 1 country3,300 target enrollmentStarted: March 15, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
3,300
Locations
6
Primary Endpoint
PVA strip positivity

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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).

Outcomes

Primary Outcomes

PVA strip positivity

Time Frame: 72 hours after sample collection

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Colorado School of Public Health
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Thomas Jaenisch

Associate Professor

Colorado School of Public Health

Study Sites (6)

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