Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-25 @ 1:59 PM
Study NCT ID:
NCT04354792
Status:
COMPLETED
Last Update Posted:
2020-06-17
First Post:
2020-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Asymptomatic COVID-19 Infection Among Healthcare Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum SARsCOV-2 IGg to assess immunological state of HCWs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-16', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-16', 'lastUpdatePostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of IGg seropositive health care workers', 'timeFrame': 'single measurement from each person collected over 2 months', 'description': 'health care workers who have positive IGg in seum'}], 'secondaryOutcomes': [{'measure': 'Differentiation between low risk and high risk HCWs', 'timeFrame': '2 months through out duration of study', 'description': 'to know positive IGg persons and IGg negative persons to understand risk factors'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immunologic Activity Alteration']}, 'referencesModule': {'references': [{'pmid': '32105632', 'type': 'BACKGROUND', 'citation': 'Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.'}, {'pmid': '32183930', 'type': 'BACKGROUND', 'citation': 'Mizumoto K, Kagaya K, Zarebski A, Chowell G. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro Surveill. 2020 Mar;25(10):2000180. doi: 10.2807/1560-7917.ES.2020.25.10.2000180.'}]}, 'descriptionModule': {'briefSummary': 'To assess the seroprevalence of SARS-CoV-2 IgG in Health care workers in three University Hospitals', 'detailedDescription': 'The proposed study is a cross sectional study that will be carried out among HCWs in three University hospitals namely Kasr Alaini , Ain Shams , and Zagazeg Hospitals, employing a quantitative survey.\n\nII-Study population Participants will be the HCWs at great risk of getting an infection which include those who are in direct contact with respiratory secretions.\n\nInclusion criteria Age: From 25 to 60 years old Department: physicians and nurses from the operating room, critical care department, emergency department, pulmonology department.\n\nThe potential participants will be given an information sheet and time to review this information before informed consent is sought. After the potential participants have agreed to be enrolled in the study, an informed consent will be obtained by the Investigator.\n\nIII- Procedures and Data collection:\n\nSerum Collection and Interview A- Detecting Serum IgG against SARS-CoV2\n\nBlood samples will be collected from the enrolled HCWs. Sample collection, processing, and laboratory testing will follow guidance from the World Health Organization.(5) The sensitivity and specificity reported by the manufacturer for IgM are 88.2% and 99.0% respectively, and for IgG are 97.8% and 97.9%.\n\nB- Structured Interview questionnaire\n\nA structured - interview questionnaire using closed ended question format will be used to obtain information on:\n\n1. Socio-demographic characteristics of the interviewees asking about age, sex, residence, education, occupation, department, Job title, hospital name, medical experience in years, marital status, living with family, and having children or not.\n2. History of medical conditions, and history of performing procedures with transmission risk (date, place, type, duration, and frequency),\n3. The use of personal protection, i.e., wearing of N95 masks, gloves, and gown, and consistent handwashing.\n4. In addition, information will be collected regarding any clinical signs or symptoms in the worker past 3 months, including fever, cough, shortness of breath, or radiographically confirmed pneumonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be the HCWs at great risk of getting an infection which include those who are in direct contact with respiratory secretions.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: From 25 to 60 years old\n* Department: physicians and nurses from the operating room, critical care department, emergency department, pulmonology department.\n\nExclusion Criteria:\n\n* pregnant\n* Age over 60 years'}, 'identificationModule': {'nctId': 'NCT04354792', 'briefTitle': 'Asymptomatic COVID-19 Infection Among Healthcare Workers', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Asymptomatic SARS- CoV2 Infection Among Healthcare Workers in Three University Hospitals: A Cross Sectional Study.', 'orgStudyIdInfo': {'id': 'N-31-2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Serum SARs COV 2 IGg screening in health care workers', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood samples will be collected from the enrolled HCWs. Sample collection, processing, and laboratory testing will follow guidance from the World Health Organization'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11559', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed M Mukhtar, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of anesthesia and intensive care', 'investigatorFullName': 'Ahmed Mukhtar', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}