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

NCT05145803 | Unknown

• 1 other identifier: 21-2823
• Study Type: observational
• Target: 3,300
• Locations: 1 country
• Sites: 6

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.

Conditions

COVID-19; SARS-CoV2 Infection

Keywords

COVID-19 Transmission; SARS-CoV2 Transmission

Outcome Measures

Primary Outcomes (1)

• PVA strip positivity

  72 hours after sample collection

Study Arms (1)

College Students

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.

Device: Polyvinylalcohol strip [diagnostic]

Interventions

Polyvinylalcohol strip [diagnostic] DEVICE

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).

College Students

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Students 18 years and older

You may qualify if:

• 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 \[CONTACTS\]

You may not qualify if:

• \< 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).

Sponsors & Collaborators

• Colorado School of Public Health: lead
• Colorado State University: collaborator
• University of Colorado, Boulder: collaborator
• Colorado Mesa University: collaborator
• Regis University: collaborator
• Denver Health Medical Center: collaborator
• University of Colorado, Colorado Springs: collaborator
• University of Colorado, Denver: collaborator

Study Sites (6)

Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

University of Colorado, Boulder

Boulder, Colorado, 80309, United States

RECRUITING

University of Colorado, Colorado Springs

Colorado Springs, Colorado, 80918, United States

RECRUITING

Denver Health

Denver, Colorado, 80204, United States

RECRUITING

Regis University

Denver, Colorado, 80221, United States

RECRUITING

Colorado State University

Fort Collins, Colorado, 80523, United States

RECRUITING

Related Publications (1)

• Jaenisch T, Lamb MM, Gallichotte EN, Adams B, Henry C, Riess J, van Sickle JT, Hawkins KL, Montague BT, Coburn C, Conners Bauer L, Kovarik J, Hernandez MT, Bronson A, Graham L, James S, Hanenberg S, Kovacs J, Spencer JS, Zabel M, Fox PD, Pluss O, Windsor W, Winstanley G, Olson D, Barer M, Berman S, Ebel G, Chu M. Investigating transmission of SARS-CoV-2 using novel face mask sampling: a protocol for an observational prospective study of index cases and their contacts in a congregate setting. BMJ Open. 2022 Nov 23;12(11):e061029. doi: 10.1136/bmjopen-2022-061029.

  PMID: 36418127 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Nasal swabs, PVA in masks, venous blood sample \[1x\], dried blood spots \[optional\]

MeSH Terms

Conditions

COVID-19

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Geoffrey Winstanley, PharmD

  Colorado School of Public Health

  STUDY DIRECTOR

• Molly Lamb, PhD

  Colorado School of Public Health

  PRINCIPAL INVESTIGATOR

• May Chu, PhD

  Colorado School of Public Health

  PRINCIPAL INVESTIGATOR

• Thomas Jaenisch, MD, PhD

  Colorado School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Jaenisch, MD, PhD

CONTACT

720-626-1094; thomas.jaenisch@cuanschutz.edu

May Chu, PhD

CONTACT

may.chu@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 6, 2021
• Study Start: March 15, 2021
• Primary Completion: March 9, 2022
• Study Completion: September 1, 2022
• Last Updated: December 20, 2021

Record last verified: 2021-12

Locations

US (6)