Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-28 @ 11:02 AM
Study NCT ID:
NCT04831866
Status:
COMPLETED
Last Update Posted:
2022-04-13
First Post:
2021-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Surveillance and Exposure Testing in School Communities
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-05', 'studyFirstSubmitDate': '2021-04-02', 'studyFirstSubmitQcDate': '2021-04-02', 'lastUpdatePostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Surveillance Cohort.', 'timeFrame': '2 years', 'description': 'Proportion of students/staff with positive SARS-CoV-2 test identified by surveillance testing.'}, {'measure': 'Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Exposure Cohort.', 'timeFrame': '2 years', 'description': 'Proportion of students/staff with positive SARS-CoV-2 test following within-school exposure.'}, {'measure': 'Describe return to school outcomes in Kindergarten through 12th grade schools in Surveillance Cohort.', 'timeFrame': '2 years', 'description': 'Proportion of students who return to in-person education in Fall 2021, Spring 2022, and Fall 2022 from participating schools conducting surveillance testing compared to districts without testing.'}, {'measure': 'Describe return to school outcomes in Kindergarten through 12th grade schools in Exposure Cohort.', 'timeFrame': '2 years', 'description': 'Mean time to return-to-school after SARS-CoV-2 exposure in the month after initiation of the school-provided testing program compared to the month prior to initiation of the school-provided testing program.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '36412278', 'type': 'DERIVED', 'citation': 'Kalu IC, Zimmerman KO, Goldman JL, Keener Mast D, Blakemore AM, Moorthy G, Boutzoukas AE, Campbell MM, Uthappa D, DeLaRosa J, Potts JM, Edwards LJ, Selvarangan R, Benjamin DK, Mann TK, Schuster JE. SARS-CoV-2 Screening Testing Programs for Safe In-person Learning in K-12 Schools. J Pediatric Infect Dis Soc. 2023 Feb 27;12(2):64-72. doi: 10.1093/jpids/piac119.'}]}, 'descriptionModule': {'briefSummary': "This is a prospective, observational study of COVID-19 surveillance and exposure testing in school communities. Participating school communities are providing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests to students and staff at their schools per school, local, and national guidelines. This study will combine data received from the schools with data collected directly from participants to guide analysis of the co-primary objectives. Participants will be grouped into two different cohorts, depending on each school's SARS-CoV-2 test administration practices.\n\nSurveillance Cohort: Schools participating in this cohort will be performing surveillance testing weekly on approximately 10-20% of students and 100% of staff.\n\nExposure Cohort: Schools participating in this cohort will be performing exposure testing on students and staff who have been identified as having close contact with school members diagnosed with SARS-CoV-2 infection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All students and staff who are members of participating school communities will be given the opportunity to consent to this study. Both children and adult school community members will be included in this study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Data from all participating school communities will be included in this study (no inclusion/exclusion criteria will be assessed).\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04831866', 'briefTitle': 'COVID-19 Surveillance and Exposure Testing in School Communities', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Coronavirus Disease 2019 (COVID-19) Surveillance and Exposure Testing in School Communities', 'orgStudyIdInfo': {'id': 'Pro00108049'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surveillance Cohort', 'description': 'Surveillance Cohort: Schools participating in this cohort will be performing surveillance testing weekly on approximately 10-20% of students and 100% of staff.'}, {'label': 'Exposure Cohort', 'description': 'Exposure Cohort: Schools participating in this cohort will be performing exposure testing on students and staff who have been identified as having close contact with school members diagnosed with SARS-CoV-2 infection.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham Charter Schools', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28677', 'city': 'Statesville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Iredell-Statesville Schools', 'geoPoint': {'lat': 35.78264, 'lon': -80.8873}}], 'overallOfficials': [{'name': 'Kanecia Zimmerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}