Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-30 @ 12:06 PM
Study NCT ID:
NCT04682132
Status:
UNKNOWN
Last Update Posted:
2021-04-21
First Post:
2020-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polk COVID-19 and Flu Response
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': 'D000917', 'term': 'Antibody Formation'}], 'ancestors': [{'id': 'D007110', 'term': 'Immunity, Active'}, {'id': 'D056704', 'term': 'Adaptive Immunity'}, {'id': 'D007109', 'term': 'Immunity'}, {'id': 'D055633', 'term': 'Immune System Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 686}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-19', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of COVID-19 amongst county emergency personnel', 'timeFrame': 'May-December 2020', 'description': 'To assess the prevalence of COVID-19 amongst county emergency personnel'}], 'secondaryOutcomes': [{'measure': 'Correlation of common COVID-19 symptoms with result of COVID-19 test', 'timeFrame': 'May-December 2020', 'description': 'To correlate common COVID-19 symptoms with result of COVID-19 test'}, {'measure': 'Co-existence of influenza and COVID-19 positive test results', 'timeFrame': 'May-December 2020', 'description': 'Co-existence of influenza and COVID-19 positive test results with or without symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Study Objectives:\n\nTo perform COVID-19 diagnostic and serologic testing on emergency medical personnel in Polk County to determine:\n\n1. COVID-19 prevalence\n2. Rate of convalesced personnel (+antibodies)\n3. Rate of asymptomatic carriers', 'detailedDescription': "This observational study involves a community wide program offering free COVID-19 testing to county front line workers, including EMS personnel, board of county commissioners and sheriffs' office personnel. These personnel will also be asked to fill out a survey that asks about their medical history and which of any symptoms they have experienced in the prior three weeks. The survey is voluntary and written informed consent is obtained . EMS personnel can still get the free testing even if they do not want to fill out the survey.\n\nThe primary objective of the study is to describe the prevalence of COVID-19 antigen and IgM and IgG markers amongst our county/EMS workers.\n\nThe secondary objective is to describe whether the antigen/antibody markers are significantly correlated to the presence of a set of symptoms in the prior 3 weeks, and/or to the baseline demographics such as age, sex, and presence of co-morbidities."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Volunteers of Polk County (FL) emergency personnel', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPolk County (FL) emergency personnel including EMS, Fire Rescue, Board of County Commissioners, and Sheriff's office\n\nExclusion Criteria:\n\nAge \\< 18"}, 'identificationModule': {'nctId': 'NCT04682132', 'acronym': 'PCFR', 'briefTitle': 'Polk COVID-19 and Flu Response', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Polk County Fire Rescue'}, 'officialTitle': 'County-wide Emergency Personnel Assessment of COVID-19 and Influenza Status', 'orgStudyIdInfo': {'id': '00001784'}}, 'armsInterventionsModule': {'interventions': [{'name': 'COVID-19 antigen and antibody tests, and influenza rapid test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Study volunteers will be offered free COVID-19 and influenza testing and the opportunity to complete an electronic survey about any symptoms.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33830', 'city': 'Bartow', 'state': 'Florida', 'country': 'United States', 'facility': 'Polk County Fire Rescue', 'geoPoint': {'lat': 27.89641, 'lon': -81.84314}}], 'overallOfficials': [{'name': 'Campion, Breanna <breannacampion@polk-county.net> Campion', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Polk County Fire Rescue'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Polk County Fire Rescue', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}