Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-30 @ 8:46 PM
Study NCT ID:
NCT04472793
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2020-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repeated Employee Testing for Understanding Our Recovery to Normal
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum and DNA Samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2020-06-03', 'studyFirstSubmitQcDate': '2020-07-14', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The 6-month cumulative incidence of acquired COVID infection in the study cohort.', 'timeFrame': 'Weekly for 6 months', 'description': 'Acquired COVID is defined as testing negative for COVID at baseline and having 1 or more weekly nasal swab samples testing positive for the virus by PCR'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is 1) to conduct a prospective longitudinal surveillance research trial, enrolling up to 200 CCHMC employees as they come back to work, and then following their clinical and laboratory parameters for up to 12 months; and 2) to support the ongoing development of diagnostic techniques for COVID-19. The overall goal is to investigate patterns of SARS-COV-2 infection, including immunological recovery and genetic risk factors, among CCHMC employees to better understand how to safely reintroduce the CCHMC work force back into their normal routines.', 'detailedDescription': "As the global and pandemic spread of the novel coronavirus (SARS-CoV-2, COVID-19) continues, many knowledge gaps remain with regard to the epidemiology and transmission of infection, as well as the normal immunological responses after viral exposure. Cincinnati only recently (March 14, 2020) had its first confirmed case of COVID-19, and through shelter-in-place and social distancing efforts, has avoided the community spread experienced by some other large metropolitan areas. As investigators contemplate the gradual reintroduction of the Cincinnati Children's Hospital Medical Center (CCHMC) workforce back into the hospital, it is imperative that investigators determine the current prevalence of infection among CCHMC employees, measure the cumulative incidence of infection over the next 12 months, investigate the normal antibody patterns after infection, and help elucidate what constitutes a protective immunological response. Investigators have a unique but time-limited opportunity to optimally track the epidemiology and natural history of SARS-CoV-2 infection at CCHMC, including risk factors for transmission and immunological recovery. RETURN will investigate epidemiological and immunological features of SARS-CoV-2 virus infection in a limited cohort of CCHMC employees, as they return from the current shelter-at-home directive toward a normal work environment. By collecting and analyzing weekly serial samples for SARS-CoV-2 (nasal swab for virus by PCR) and monthly serological exposure (serum antibodies by ELISA), investigators will determine the prevalence and cumulative incidence of exposure to SARS-CoV-2; document the antibody responses over time; identify cases of apparent viral recrudescence or re-infection; and create models of transmission risk among CCHMC employees."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adult men and women who are employed full time at Cincinnati Children's Hospital.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Current full-time employees at Cincinnati Children's Hospital\n* Age: \\>18.0 years of age, at the time of enrollment\n* Cell phone that can be used for text messaging or web-based viewing of surveys\n* Willing and able to provide informed consent\n* Ability to comply with all study related evaluations and follow-up\n\nExclusion Criteria:\n\n* Previous proven SARS-CoV-2 infection (positive PCR-based molecular test)\n* Any condition or illness that makes study participation ill-advised\n* Currently or planning to enroll in a COVID-19 vaccine or prophylaxis study"}, 'identificationModule': {'nctId': 'NCT04472793', 'acronym': 'RETURN', 'briefTitle': 'Repeated Employee Testing for Understanding Our Recovery to Normal', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Repeated Employee Testing for Understanding Our Recovery to Normal', 'orgStudyIdInfo': {'id': 'RETURN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Full-Time CCHMC Employees', 'interventionNames': ['Diagnostic Test: SARS-CoV-2']}], 'interventions': [{'name': 'SARS-CoV-2', 'type': 'DIAGNOSTIC_TEST', 'description': '1. Testing weekly samples from nasal swabs to promptly diagnose acute COVID-19 infection.\n2. Testing monthly serum samples to document post-viral infection.', 'armGroupLabels': ['Full-Time CCHMC Employees']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Russell Ware, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}, {'name': 'Mary Allen Staat, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}