Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2026-02-25 @ 6:56 PM
Study NCT ID:
NCT04405466
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2020-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Feasibility of Screening for SARS-CoV-2 Among Healthy 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples, throat swab'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 417}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2020-05-25', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune responses to components of SARS-Cov-2', 'timeFrame': 'up to visit 3 (day 40)', 'description': 'Evaluation of immune responses to components of SARS-CoV-2 as well as evaluation of Swab for the presence of SARS-CoV-2 by PCR. Determination of the difference between the study groups in anti-SARS-CoV 2 seropositivity status. Analysis of trends in CD4/CD8 concentrations over time and correlation with immunoglobulin G (IgG) Levels and new assay evaluation.'}, {'measure': 'Swabs for the presence of SARSCoV-2', 'timeFrame': 'up to visit 3 (day 40)', 'description': 'Evaluation of Swab for the presence of SARS-CoV-2 by PCR and determination of the difference between the study groups in anti-SARS-CoV 2 seropositivity status.'}], 'secondaryOutcomes': [{'measure': 'Difference between the study groups in anti-SARS-CoV 2 seropositivity status', 'timeFrame': 'up to visit 3 (day 40)', 'description': 'Evaluation of immune responses to components of SARS-CoV-2 as well as evaluation of Swab for the presence of SARS-CoV-2 by PCR. Determination of the difference between the study groups in anti-SARS-CoV 2 seropositivity status and analysis of trends in CD4/CD8 concentrations over time and correlation with IgG Levels as well as new assay evaluation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This is a prospective, epidemiological, cohort study to assess the feasibility of screening healthy asymptomatic workers for the presence of severe acute respiratory syndrome SARS-CoV-2 by pharyngeal swaps and serology at baseline, day 21 and day 40.', 'detailedDescription': 'This study has been designed to assess the feasibility of screening asymptomatic workers and to investigate the extent of infection, as determined by pharyngeal swaps analysis and immune response against the virus and virus specific CD4+ and CD8+ T-cell analysis. Furthermore, the extent to which virus-specific CD4+ and CD8+ T-cells are induced is investigated as well as the persistence of virus-specific memory CD4+ and CD8+ T-cells -especially in asymptomatic infected persons.\n\nIn total, approximately up to 500 workers will be enrolled into the trial to have 450 evaluable subjects at the end of the study. There will be three individual cohorts of workers working in different departments: workers from the production area (cohort 1), workers from the laboratory area (cohort 2) and workers working in other areas (cohort 3).\n\nThe fraction of asymptomatic or subclinical infections should be determined as well as the kinetics of the immune responses. For each timepoint the difference between the cohorts is investigated. This study also aims to evaluate the impact of sanitary and preventive measures taken within the company during the pandemic situation.\n\nEpidemiological exposure data and biological samples will be systematically collected. The present study is being conducted in line with World Health Organization recommendations to help understanding the epidemiology of SARS-Cov-2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Workers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy workers asymptomatic for SARS-CoV-2\n* Ability to consent with the study and its procedures\n* Age above 18 years old\n* Full time employee on site at least 3 full working days a week\n* Working in a shared office/lab/manufacturing environment where at least 3 employees are present and/or having frequent contact with others i.e reception area, transportation and delivery areas.\n\nExclusion Criteria:\n\nWorkers presenting symptoms that could be signs of a SARS-CoV-2 infection such as:\n\n* fever ≥38°C\n* chills\n* fatigue\n* muscle ache (myalgia)\n* sore throat\n* cough\n* runny nose (rhinorrhea)\n* shortness of breath (dyspnea)\n* wheezing\n* chest pain\n* other respiratory Symptoms\n* headache\n* nausea/vomiting'}, 'identificationModule': {'nctId': 'NCT04405466', 'briefTitle': 'A Study to Assess the Feasibility of Screening for SARS-CoV-2 Among Healthy Workers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Miltenyi Biomedicine GmbH'}, 'officialTitle': 'A Prospective, Epidemiological, Cohort Study to Assess the Feasibility of Screening Healthy Asymptomatic Workers for the Presence of SARS-CoV-2 by Pharyngeal Swaps and Serology at Baseline, Day 21 and Day 40', 'orgStudyIdInfo': {'id': 'M-2020-360'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Workers working within a production area', 'interventionNames': ['Procedure: Blood sampling', 'Procedure: Throat swab']}, {'label': 'Group 2', 'description': 'Workers working within a laboratory area', 'interventionNames': ['Procedure: Blood sampling', 'Procedure: Throat swab']}, {'label': 'Group 3', 'description': 'Workers working within other areas', 'interventionNames': ['Procedure: Blood sampling', 'Procedure: Throat swab']}], 'interventions': [{'name': 'Blood sampling', 'type': 'PROCEDURE', 'description': 'Blood samples', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}, {'name': 'Throat swab', 'type': 'PROCEDURE', 'description': 'Throat swab', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51429', 'city': 'Bergisch Gladbach', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Miltenyi Biotec B.V. & Co. KG', 'geoPoint': {'lat': 50.9856, 'lon': 7.13298}}], 'overallOfficials': [{'name': 'Barbara von Ingersleben, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Miltenyi Biotec B.V. & Co. KG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Miltenyi Biomedicine GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}