COVID-19NCT05145803
Asymptomatic and Pre-symptomatic Transmission of SARS-CoV-2 in a Community Congregant Setting
An observational study of COVID-19 and SARS-CoV2 Infection, run by Colorado School of Public Health at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV2 Infection
- What is being tested?
- Polyvinylalcohol strip [diagnostic]
- Type of treatment
- Medical device
- How many people
- 3,300 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Mar 2021to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Students 18 years and older
Who may be able to join
- 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]
Who cannot join
- < 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 locations and contacts
6 sites in 1 country.
May Chu, PhD contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Anschutz Medical Campus
Aurora, Colorado, 80045
Brian Montague, DO, Brian.Montague@cuanschutz.edu
Brian Montague, DO
- Recruiting
University of Colorado, Boulder
Boulder, Colorado, 80309
Leisha Conners Bauer, MPA, Leisha.ConnersBauer@Colorado.EDU
Leisha Conners Bauer, MPA
- Recruiting
University of Colorado, Colorado Springs
Colorado Springs, Colorado, 80918
Stephanie Hanenberg, MSN, 719-255-4444, shanenbe@uccs.edu
Stephanie Hanenberg, MSN
- Recruiting
Denver Health
Denver, Colorado, 80204
Kellie Hawkins, MD, Kellie.Hawkins@dhha.org
Kellie Hawkins, MD
- Recruiting
Regis University
Denver, Colorado, 80221
Stephanie James, PhD, sjames001@regis.edu
Stephanie James, PhD
- Recruiting
Colorado State University
Fort Collins, Colorado, 80523
Jeannine Riess, 970-491-6121
Joni T van Sickle, BS
About this study
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
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
- Being tested
- Polyvinylalcohol strip [diagnostic]
- Keywords
- COVID-19 Transmission, SARS-CoV2 Transmission
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Polyvinylalcohol strip [diagnostic] |
What is being measured
The primary outcome is the main question the study is designed to answer.
PVA strip positivity
Measured: 72 hours after sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start15 Mar 2021
- Primary completion9 Mar 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University, University of Colorado, Boulder, Colorado Mesa University, Regis University, Denver Health Medical Center, University of Colorado, Colorado Springs, University of Colorado, Denver
- Responsible party
- Principal investigator, Thomas Jaenisch, Colorado School of Public Health
- Investigators
- Geoffrey Winstanley, PharmD, Study director, Colorado School of Public HealthMolly Lamb, PhD, Principal investigator, Colorado School of Public HealthMay Chu, PhD, Principal investigator, Colorado School of Public HealthThomas Jaenisch, MD, PhD, Principal investigator, Colorado School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145803
- Sponsor's protocol ID
- 21-2823
- Status last verified
- Dec 2021
- First submitted
- 1 Dec 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36418127
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05145803
- Acronym / sponsor ID
- 21-2823
- Conditions
- COVID-19, SARS-CoV2 Infection
- Keywords
- COVID-19 Transmission, SARS-CoV2 Transmission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- Colorado School of Public HealthUniversity, hospital or other
- Collaborators
- Colorado State University, University of Colorado, Boulder, Colorado Mesa University, Regis University, Denver Health Medical Center, University of Colorado, Colorado Springs, University of Colorado, Denver
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 9 Mar 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| College Students | – | Device: Polyvinylalcohol strip [diagnostic]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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Students 18 years and older
Key inclusion criteria (2 listed)
- 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]
Key exclusion criteria (1 listed)
- < 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | College Students |
Primary outcome
PVA strip positivity
Time frame: 72 hours after sample collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Derived from this study: PubMed 36418127Jaenisch 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
May Chu, PhD contact
Geoffrey Winstanley, PharmD study director
Colorado School of Public Health
Molly Lamb, PhD principal investigator
Colorado School of Public Health
May Chu, PhD principal investigator
Colorado School of Public Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV2 Infection, run by Colorado School of Public Health at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Jaenisch, MD, PhD (720-626-1094, thomas.jaenisch@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PVA strip positivity (time frame: 72 hours after sample collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05145803, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.