Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT04527432
Status:
COMPLETED
Last Update Posted:
2025-04-02
First Post:
2020-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COVID-19 Health Professional Impact Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1504}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2020-08-24', 'studyFirstSubmitQcDate': '2020-08-24', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of employees tested who have evidence of SARS-CoV-2 antibodies', 'timeFrame': '12 months', 'description': 'evidence of SARS-CoV-2 antibodies'}, {'measure': 'Factors associated with a positive test', 'timeFrame': '12 months', 'description': 'Survey to establish\n\n* Type of healthcare role\n* Ethnicity\n* Age\n* Index of multiple deprivation\n* Previous RT-PCR test status\n* Previous clinical COVID infection\n* Previous period of self isolation\n* Level of COVID-19 related anxiety\n* Presence of one or more high risk factors for COVID 19\n* Presence or absence of self-reported COVID 19 symptoms'}, {'measure': 'Likelihood of clinically relevant (causing illness) infection with SARS-CoV-2 in subjects with both positive and negative SARS-CoV-2 antibody tests', 'timeFrame': '12 months', 'description': 'Infection compared to antibody presence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus Infection', 'Severe Acute Respiratory Syndrome']}, 'referencesModule': {'references': [{'pmid': '35957800', 'type': 'RESULT', 'citation': 'Sethi S, Manuelpillai N, Mandal A, Simpson O, Morrissey H, Ball P, Sharrod-Cole H, Ford C, Whittaker AC, Drayson M, Race A, Bateman J, Basu S, Cotton J. COVID-19 seroprevalence after the first UK wave of the pandemic and its association with the physical and mental wellbeing of secondary care healthcare workers. Brain Behav Immun Health. 2022 Oct;24:100492. doi: 10.1016/j.bbih.2022.100492. Epub 2022 Aug 6.'}]}, 'descriptionModule': {'briefSummary': "The COVID-19 (coronavirus) pandemic has had a huge impact on healthcare resources and staff in the UK. Understanding the key risk factors associated with infection amongst healthcare workers is essential for future pandemic response plans.\n\nCurrently there are scarce data relating to the infection rates and associated factors amongst healthcare workers in the United Kingdom (UK). Studies of infection rates in healthcare workers have largely relied on the real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test to date and it appears that Healthcare workers are twice as likely to succumb to Coronavirus infection, when compared to the general population and those from Black and minority ethnic (BAME) backgrounds appear to be particularly at risk.\n\nCurrently there is no evidence that the presence of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibodies provides seasonal or long term immunity to future infection.\n\nTherefore, this study aims to understand the current level of SARS-CoV-2 antibody positivity and try to determine the likely risk to healthcare workers in the UK to COVID-19 infection. This study hopes to find out whether certain individual characteristics will have an impact on likelihood of infection susceptibility and antibody response and determine the impact of the presence of antibodies on the likelihood of future clinical infection over a 12 month period.\n\nThe study involves an initial online survey and linkage to the recent antibody test, then a further online survey in 6 and 12 months' time. The data obtained will be linked to data that the Human Resources Department (HR) holds.\n\nParticipants also have the option to partake in another antibody test at 6 and 12 months' time and linked to the data collected.", 'detailedDescription': "Participants will have access to the study via the link given in an SMS (Short Message Service - text message) which will direct then to the first online survey.\n\nThey will then be contacted again in 6 and 12 months' time to complete the online survey again.\n\nThe survey answers will be linked to the results of the antibody tests by their mobile and Employment Number and also to data held about them by the HR Department.\n\nThe survey will take approximately 15 minutes to complete and will include questions on the following: profession; work-line type; demographics and behavioural factors; ethnicity; and symptoms (if COVID 19 was manifested).\n\nParticipants can also attend for another blood test (SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibody test) to detect any presence of antibodies at 6 and 12 months (optional) which will again be linked to the survey and HR data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All Staff employed by Royal Wolverhampton Trust, having undergone the SARS-CoV-2antibody test at the Trust's testing facility\n\nExclusion Criteria:\n\n* Royal Wolverhampton NHS Trust staff who have not participated in antibody testing • Staff who have opted out to receiving the text message invite and be part of the study"}, 'identificationModule': {'nctId': 'NCT04527432', 'acronym': 'CHIP', 'briefTitle': 'COVID-19 Health Professional Impact Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The Royal Wolverhampton Hospitals NHS Trust'}, 'officialTitle': 'A Pilot Assessment of the COVID-19 Antibody Status and Associated Factors, in Individuals Employed by a Large Acute NHS Trust During the Coronavirus Pandemic', 'orgStudyIdInfo': {'id': '2020COV112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All participants', 'description': 'Survey at 6 and 12 months time with optional antibody tests', 'interventionNames': ['Other: Survey', 'Diagnostic Test: SARS-CoV-2 antibody test']}], 'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'Survey at baseline, 6 and 12 months', 'armGroupLabels': ['All participants']}, {'name': 'SARS-CoV-2 antibody test', 'type': 'DIAGNOSTIC_TEST', 'description': 'SARS-CoV-2 antibody test results and testing again at 6 and 12 months', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WV10 0QP', 'city': 'Wolverhampton', 'country': 'United Kingdom', 'facility': 'The Royal Wolverhampton NHS Trust', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}], 'overallOfficials': [{'name': 'Supratik Basu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Royal Wolverhampton NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Results will be published in journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Royal Wolverhampton Hospitals NHS Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Wolverhampton', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}