Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-29 @ 10:58 AM
Study NCT ID:
NCT05145803
Status:
UNKNOWN
Last Update Posted:
2021-12-20
First Post:
2021-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Asymptomatic and Pre-symptomatic Transmission of SARS-CoV-2 in a Community Congregant Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Nasal swabs, PVA in masks, venous blood sample \\[1x\\], dried blood spots \\[optional\\]'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-06', 'studyFirstSubmitDate': '2021-12-01', 'studyFirstSubmitQcDate': '2021-12-01', 'lastUpdatePostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PVA strip positivity', 'timeFrame': '72 hours after sample collection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19 Transmission', 'SARS-CoV2 Transmission'], 'conditions': ['COVID-19', 'SARS-CoV2 Infection']}, 'referencesModule': {'references': [{'pmid': '36418127', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Students 18 years and older', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\\]\n* Individuals age ≥ 18 years and known to be contacts of the index patients \\[CONTACTS\\]\n\nExclusion Criteria:\n\n* \\< 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).'}, 'identificationModule': {'nctId': 'NCT05145803', 'briefTitle': 'Asymptomatic and Pre-symptomatic Transmission of SARS-CoV-2 in a Community Congregant Setting', 'organization': {'class': 'OTHER', 'fullName': 'Colorado School of Public Health'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '21-2823'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'College Students', 'description': 'Collegiate students tested positive for SARS-CoV-2 by a molecular reference test (PCR test or antigen test) (index patients).\n\nCollegiate students known to be contacts of the index patients.', 'interventionNames': ['Device: Polyvinylalcohol strip [diagnostic]']}], 'interventions': [{'name': 'Polyvinylalcohol strip [diagnostic]', 'type': 'DEVICE', 'description': '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).', 'armGroupLabels': ['College Students']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian Montague, DO', 'role': 'CONTACT', 'email': 'Brian.Montague@cuanschutz.edu'}, {'name': 'Brian Montague, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80309', 'city': 'Boulder', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leisha Conners Bauer, MPA', 'role': 'CONTACT', 'email': 'Leisha.ConnersBauer@Colorado.EDU'}, {'name': 'Leisha Conners Bauer, MPA', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gloria Brisson, MSN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado, Boulder', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80918', 'city': 'Colorado Springs', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie Hanenberg, MSN', 'role': 'CONTACT', 'email': 'shanenbe@uccs.edu', 'phone': '719-255-4444'}, {'name': 'Stephanie Hanenberg, MSN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado, Colorado Springs', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kellie Hawkins, MD', 'role': 'CONTACT', 'email': 'Kellie.Hawkins@dhha.org'}, {'name': 'Kellie Hawkins, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Denver Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80221', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie James, PhD', 'role': 'CONTACT', 'email': 'sjames001@regis.edu'}, {'name': 'Stephanie James, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Regis University', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80523', 'city': 'Fort Collins', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeannine Riess', 'role': 'CONTACT', 'phone': '970-491-6121'}, {'name': 'Joni T van Sickle, BS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jeannine Riess, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Colorado State University', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}], 'centralContacts': [{'name': 'Thomas Jaenisch, MD, PhD', 'role': 'CONTACT', 'email': 'thomas.jaenisch@cuanschutz.edu', 'phone': '720-626-1094'}, {'name': 'May Chu, PhD', 'role': 'CONTACT', 'email': 'may.chu@cuanschutz.edu'}], 'overallOfficials': [{'name': 'Geoffrey Winstanley, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Colorado School of Public Health'}, {'name': 'Molly Lamb, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Colorado School of Public Health'}, {'name': 'May Chu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Colorado School of Public Health'}, {'name': 'Thomas Jaenisch, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Colorado School of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colorado School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Colorado State University', 'class': 'OTHER'}, {'name': 'University of Colorado, Boulder', 'class': 'OTHER'}, {'name': 'Colorado Mesa University', 'class': 'OTHER'}, {'name': 'Regis University', 'class': 'OTHER'}, {'name': 'Denver Health Medical Center', 'class': 'OTHER'}, {'name': 'University of Colorado, Colorado Springs', 'class': 'OTHER'}, {'name': 'University of Colorado, Denver', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Thomas Jaenisch', 'investigatorAffiliation': 'Colorado School of Public Health'}}}}