Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT04389294
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2020-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HSS Covid-19 Antibody Serology Among Surgeons & Anesthesiologists
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'SoffinE@HSS.edu', 'phone': '(212) 606-1206', 'title': 'Dr. Ellen M. Soffin', 'organization': 'Hospital for Special Surgery'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was not collected', 'description': 'Adverse event data was not collected', 'eventGroups': [{'id': 'EG000', 'title': 'Surgeons and Anesthesiologists', 'description': 'Surgeons and anesthesiologists at a specialty orthopaedic hospital', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With SARS-CoV-2 IgG Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgeons and Anesthesiologists', 'description': 'Surgeons and anesthesiologists at a specialty orthopaedic hospital'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Serology Test #1 (Study Enrollment) and Test #2 (3 months apart)', 'description': 'Prevalence of SARS-CoV-2 IgG antibodies by serology testing in participants at the time of study enrollment or 3 months later', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participating surgeons and anesthesiologists at a specialty orthopaedic hospital'}, {'type': 'SECONDARY', 'title': 'Differences in Sex Between IgG Antibody-positive vs. Negative Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgeons and Anesthesiologists', 'description': 'Surgeons and anesthesiologists at a specialty orthopaedic hospital'}], 'classes': [{'categories': [{'title': 'SARS-CoV-2 IgG Positive Females', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Negative Females', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Positive Males', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Negative Males', 'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020', 'description': 'Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included demographics such as sex.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All surgeon and anesthesiologist participants with complete survey and serology testing data'}, {'type': 'SECONDARY', 'title': 'Number of Asymptomatic Participants With Positive Antibody Serology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgeons and Anesthesiologists', 'description': 'Surgeons and anesthesiologists at a specialty orthopaedic hospital'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart)', 'description': 'Number of asymptomatic participants with positive antibody serology at either the study enrollment timepoint or 3 month timepoint', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of asymptomatic participants with positive antibody serology (n=89/143)'}, {'type': 'SECONDARY', 'title': 'Percentage of Antibody-positive Participants Who Subsequently Develop COVID-19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgeons and Anesthesiologists', 'description': 'Surgeons and anesthesiologists at a specialty orthopaedic hospital'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart)', 'description': 'Percentage of antibody-positive participants who subsequently develop COVID-19 at either the study enrollment timepoint or the 3 months time point', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Symptomatic participants who were antibody-positive'}, {'type': 'SECONDARY', 'title': 'Differences in Race Between IgG Antibody-positive vs. Negative Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgeons and Anesthesiologists', 'description': 'Surgeons and anesthesiologists at a specialty orthopaedic hospital'}], 'classes': [{'categories': [{'title': 'SARS-CoV-2 IgG Positive Whites', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Negative Whites', 'measurements': [{'value': '99', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Positive Blacks or African Americans', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Negative Blacks or African Americans', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Positive Asians', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Negative Asians', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Positive Others/Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Negative Others/Unknown', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020', 'description': 'Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included demographics such as race.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All surgeon and anesthesiologist participants with complete survey and serology testing data'}, {'type': 'SECONDARY', 'title': 'Differences in Average Number of Adults in Household Between IgG Antibody-positive vs. Negative Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgeons and Anesthesiologists', 'description': 'Surgeons and anesthesiologists at a specialty orthopaedic hospital'}], 'classes': [{'title': 'SARS-CoV-2 IgG Positive', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'SARS-CoV-2 IgG Negative', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020', 'description': 'Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included demographics such as number of adult household members.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All surgeon and anesthesiologist participants with complete survey and serology testing data'}, {'type': 'SECONDARY', 'title': 'Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgeons and Anesthesiologists', 'description': 'Surgeons and anesthesiologists at a specialty orthopaedic hospital'}], 'classes': [{'categories': [{'title': 'SARS-CoV-2 IgG Positive Hypertension', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Negative Hypertension', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Positive Diabetes Mellitus', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Negative Diabetes Mellitus', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Positive Pulmonary Disease', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Negative Pulmonary Disease', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Positive CAD/Cardiac Condition', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Negative CAD/Cardiac Condition', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Positive Immunocompromised', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG Negative Immunocompromised', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'SARS-CoV-2 IgG No Listed Comorbidities', 'measurements': [{'value': '113', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020', 'description': 'Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included comorbidities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All surgeon and anesthesiologist participants with complete survey and serology testing data'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participants Who Were Eligible for in Plasma Donation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgeons and Anesthesiologists', 'description': 'Surgeons and anesthesiologists at a specialty orthopaedic hospital'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Serology Test #1 (Study Enrollment) and Test #2 (3 months apart)', 'description': 'Individuals who tested positive for COVID-19 who may be eligible for convalescent plasma donation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Surgeons and anesthesiologists who completed both the survey and serology testing'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Surgeons and Anesthesiologists', 'description': 'Surgeons and anesthesiologists at a specialty orthopaedic hospital'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Surgeons and Anesthesiologists', 'description': 'Surgeons and anesthesiologists at a specialty orthopaedic hospital'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '125', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '50.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '117', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '109', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '110', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Seroprevalence of SARS-CoV-2 IgG antibodies by serology testing', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The seroprevalence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) immunoglobulin G (IgG) antibodies among surgeons and anesthesiologists and associated antibody status with coronavirus disease 2019 (COVID-19) clinical illness was measured.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All attending surgeons, anesthesiologists, and trainees in both departments (orthopedic surgery fellows, anesthesiology fellows and orthopedic surgery residents) as identified via an institutional listserv.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-15', 'size': 152548, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-02-22T09:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2020-05-08', 'resultsFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-21', 'studyFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Participants Who Were Eligible for in Plasma Donation', 'timeFrame': 'Serology Test #1 (Study Enrollment) and Test #2 (3 months apart)', 'description': 'Individuals who tested positive for COVID-19 who may be eligible for convalescent plasma donation'}], 'primaryOutcomes': [{'measure': 'Number of Participants With SARS-CoV-2 IgG Antibodies', 'timeFrame': 'Serology Test #1 (Study Enrollment) and Test #2 (3 months apart)', 'description': 'Prevalence of SARS-CoV-2 IgG antibodies by serology testing in participants at the time of study enrollment or 3 months later'}], 'secondaryOutcomes': [{'measure': 'Differences in Sex Between IgG Antibody-positive vs. Negative Participants', 'timeFrame': 'Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020', 'description': 'Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included demographics such as sex.'}, {'measure': 'Number of Asymptomatic Participants With Positive Antibody Serology', 'timeFrame': 'Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart)', 'description': 'Number of asymptomatic participants with positive antibody serology at either the study enrollment timepoint or 3 month timepoint'}, {'measure': 'Percentage of Antibody-positive Participants Who Subsequently Develop COVID-19', 'timeFrame': 'Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart)', 'description': 'Percentage of antibody-positive participants who subsequently develop COVID-19 at either the study enrollment timepoint or the 3 months time point'}, {'measure': 'Differences in Race Between IgG Antibody-positive vs. Negative Participants', 'timeFrame': 'Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020', 'description': 'Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included demographics such as race.'}, {'measure': 'Differences in Average Number of Adults in Household Between IgG Antibody-positive vs. Negative Participants', 'timeFrame': 'Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020', 'description': 'Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included demographics such as number of adult household members.'}, {'measure': 'Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants', 'timeFrame': 'Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020', 'description': 'Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included comorbidities.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to understand the infectious exposure of SARS-coronavirus 2 (SARS-CoV2) among surgeons and anesthesiologists and to correlate this status with self-reported indices of COVID-19 illness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Accredited to practice at HSS\n* All anesthesiology and surgery faculty\n* All anesthesia and orthopedic surgery fellows\n* All orthopedic surgery residents\n\nExclusion Criteria:\n\n• Refusal to participate in either of the interventions at either of the timepoints of interest'}, 'identificationModule': {'nctId': 'NCT04389294', 'briefTitle': 'HSS Covid-19 Antibody Serology Among Surgeons & Anesthesiologists', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Hospital for Special Surgery COVID-19 Antibody Serology Among Anesthesiologists and Surgeons 2020', 'orgStudyIdInfo': {'id': '2020-0850'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SARS-CoV2 serum antibody testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will have SARS-CoV2 serum antibody testing performed twice within 4 months of each other.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}