Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT04826718
Status:
COMPLETED
Last Update Posted:
2023-06-09
First Post:
2021-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SARS-CoV-2/COVID-19 Infection Among Health Care Workers
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_WITHOUT_DNA', 'description': 'Blood.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2021-03-10', 'studyFirstSubmitQcDate': '2021-03-31', 'lastUpdatePostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total number of days absent from work due to COVID-19', 'timeFrame': 'From March 2020 to March 2022', 'description': 'Absenteeism due to COVID-19 related symptoms'}, {'measure': 'Unplanned Absenteeism', 'timeFrame': '6 months after inclusion', 'description': 'Unplanned absenteeism following SARS-CoV-2 infection'}, {'measure': 'Symptomatology after infection by SARS-CoV-2', 'timeFrame': '6 months after inclusion', 'description': 'If have or not any symptomes after SARS-CoV-2 infection'}, {'measure': 'Presence or absence of anti-SARS-CoV-2 Acs', 'timeFrame': '6 months after inclusion', 'description': 'Presence or not of anti-SARS-CoV-2 Anti-N and anti-S'}, {'measure': 'Duration of anti-SARS-CoV-2 Acs', 'timeFrame': 'After infection', 'description': 'Time of duration of anti-SARS-CoV-2 Anti-N and anti-S'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV-2', 'BCG', 'Health Care Worker', 'COVID-19']}, 'descriptionModule': {'briefSummary': 'The present study finds opportunities and justifications, taking into consideration that the nature of professional practice in health needs scientific evidence resulting from systematic and systemic studies to strengthen the basis for the decisions made to have an impact on various levels, from the patient to health management itself. In addition, Cabo Verdean authorities may benefit from new evidence obtained by this study. It intends, in a growing number of health professionals exposed or infected with SARS-CoV-2, in the different health structures of the country, to contribute to substantiate a better perception of the problem and the required solutions. Therefore, assessing the potential risk factors for SARS-CoV-2 infection among healthcare workers will be essential to characterize virus transmission, preventing future infections in them and providing the associated healthcare. Due to the advances and important changes described, questions arise that guide this research and allow us to identify the problem.', 'detailedDescription': 'The problem is stated in the following starting questions:\n\nWhat conditions and factors are associated with infection and non-infection by SARS-CoV-2 among health professionals working in the three hospitals on the islands of Santiago and São Vicente? Which are they (gender, age group, profession, type of contact, etc.)? Where do the infected HCW typically work (sector)? When and how did the infection occur? What is the prevalence of SARS-CoV-2 antibody in professionals with confirmed SARS-CoV-2 infection and in HCW that thought they were not infected by SARS-CoV-2? How long do anti-SARS-CoV-2 antibodies last? What is the impact of infection on unplanned absenteeism? Which symptoms and complaints (if any) persists after SARS-CoV-2 infection?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The population of the study is composed of health professionals working in the Hospitals of the islands of Santiago and S. Vicente.\n\nIn addition to measuring infection-related exposures, specific SARS-CoV-2 infection-related parameters will also be assessed, including presence and duration of anti-SARS-CoV-2 antibodies; absenteeism due to infection; and self-reported symptomatology due to SARS-CoV-2/ COVID-19 infection. All participants be followed up to measure unplanned, infection-related absenteeism, illness-related symptomatology at 3 of for a period of 6 months. At 6 months after enrollement, all participants will also be assessed, including screening of presence of anti-SARS-CoV-2 antibodies (anti-N and anti-S).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being a healthcare professional working in one of the hospitals where the study will take place\n* Be aged ≥18 years;\n* Cases: SARS-CoV-2 infection confirmed by PCR test and/or Rapid Antigen Test;\n* Control: No evidence and/or record of past infection with SARS-CoV-2.\n\nExclusion Criteria:\n\n* Case: Confirmation of diagnosis test for SARS-CoV-2 without indication of specimen collection date.\n* Control: Suspected SARS-CoV-2 infection.'}, 'identificationModule': {'nctId': 'NCT04826718', 'briefTitle': 'SARS-CoV-2/COVID-19 Infection Among Health Care Workers', 'organization': {'class': 'OTHER', 'fullName': 'Universidade de Cabo Verde'}, 'officialTitle': 'Associated Factors in the Transmission and Dynamics of SARS-CoV-2 Infection Among Health Care Workers in Hospitals on the Islands of Santiago and São Vicente in Cabo Verde', 'orgStudyIdInfo': {'id': 'RIA2020ER-3049'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort', 'description': 'All Health Care Worker (HCW) from Hospital in Santiago and S. Vicente islands, Cabo Verde'}, {'label': 'Control', 'description': 'HCW who report no SARS-CoV-2 infection in the period prior to the interview and/or suspected COVID-19 in the period prior to the interview', 'interventionNames': ['Other: Questionaire']}, {'label': 'Cases', 'description': 'HCW who report positive SARS-CoV-2 infection confirmed by performing a positive PCR test and/or positive Rapid Antigen Test in the period prior to the interview', 'interventionNames': ['Other: Questionaire']}], 'interventions': [{'name': 'Questionaire', 'type': 'OTHER', 'otherNames': ['SARS-CoV-2 Serology (POC Test)', 'SARS-CoV-2 Serology (ELISA Test)'], 'description': 'A questionnaire will be administered to all participants to evaluate exposures related to infection at the baseline (enrollement) - Baseline questionnaire. A Follow-up questionnaire to all participants will be done after 3 and 6 months.\n\nCapillary blood collection, for diagnosis of anti-SARS-CoV-2 Antibodies by rapid test, will be done at the first interview, for all participants (cases and controls).\n\nCollection of peripheral venous blood, for analysis of the presence and duration of anti-SARS-CoV-2 Antibodies (N and S) will be done at the first interview, and after 6 months for all participants (cases and controls).', 'armGroupLabels': ['Cases', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '379C', 'city': 'Praia', 'state': 'Santiago', 'country': 'Cabo Verde', 'facility': 'Universidade de Cabo Verde', 'geoPoint': {'lat': 14.93152, 'lon': -23.51254}}], 'overallOfficials': [{'name': 'Isabel I Araújo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade de Cabo Verde'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade de Cabo Verde', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern Denmark', 'class': 'OTHER'}, {'name': 'Institute of Hygiene and Tropical Medicine, NOVA University, Lisbon, Portugal', 'class': 'UNKNOWN'}, {'name': 'National Institute of Public Health of Cape Verde, Praia, Cape Verde', 'class': 'UNKNOWN'}, {'name': 'Centro de Investigacao em Saude de Manhica', 'class': 'OTHER'}, {'name': 'European and Developing Countries Clinical Trials Partnership (EDCTP)', 'class': 'OTHER_GOV'}, {'name': 'Bandim Health Project, Bissau, Guinea-Bissau', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}