Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-01 @ 7:27 PM
Study NCT ID:
NCT05365750
Status:
COMPLETED
Last Update Posted:
2025-09-18
First Post:
2022-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COVID-19 Antibody and Reinfection Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ingrid.a.binswanger@kp.org', 'phone': '720-416-7104', 'title': 'Ingrid A Binswanger, MD, MPH', 'organization': 'Kaiser Permanente Colorado'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "Adherence to the study's testing guidance was inconsistent. We encouraged regular on-site testing but may not have captured some home-based testing results. Variable sensitivity and specificity of different serologic tests could have influenced our results. Variable sero-reversion rates across tests could have been due to variable lengths of time between the primary infection and testing. The definition of a reinfection used could have identified viral persistence."}}, 'adverseEventsModule': {'timeFrame': 'Through the completion of the study analytic period, an average of 6 months', 'description': 'This was not a clinical trial but a nested case-control study. Following IRB approved procedures, we collected adverse events (AEs) and serious adverse events (SAE) related to study procedures (surveys, testing), related and un-related COVID-related hospitalizations (SAEs), and related and unrelated all-cause deaths (SAEs). Other unrelated AEs and SAEs were not collected as part of this study focused on COVID. AEs and SAEs and deaths are reported for case-control participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Case Patients Nested Within the Cohort', 'description': 'Case patients had a reinfection, defined as a positive SARS-CoV-2 RNA test ≥ 90 days after the first positive RNA. Case patients had serology completed between the infections.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Patients Nested Within the Cohort', 'description': 'Control patients had a primary infection and serologic tests that were conducted between the primary infection and the index date. A control patient could be matched to more than one case patient if they had more than one eligible serologic test. Case patients were 1:20 matched to controls.', 'otherNumAtRisk': 1034, 'deathsNumAtRisk': 1034, 'otherNumAffected': 0, 'seriousNumAtRisk': 1034, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reinfection With SARS-CoV-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '1034', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Case Patients', 'description': 'Participants with reinfection, defined as a positive SARS-CoV-2 RNA test ≥ 90 days after the first positive RNA test'}, {'id': 'OG001', 'title': 'Control Patients', 'description': 'Participants without reinfection'}], 'classes': [{'categories': [{'title': 'Seronegative test results', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'title': 'Seropositive test results', 'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '957', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through the completion of the study analytic period, an average of 6 months', 'description': 'In this case-control analysis, case patients were participants with the outcome of reinfection. The date of reinfection was the index date. Control patients were those with a primary infection but without the outcome reinfection by the index date. The case and control participants were compared with respect to a seronegative test result (exposure) after primary infection and closest in time to the index date. Because the cases and controls were selected on the basis of the outcome, the seronegative result is listed below by case and control status.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study cohort members with a primary SARS-CoV-2 infection'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Case Patients Nested Within the Cohort', 'description': 'Case patients had a reinfection, defined as a positive SARS-CoV-2 RNA test ≥ 90 days after the first positive RNA. Case patients had serology completed between the infections.'}, {'id': 'FG001', 'title': 'Control Patients Nested Within the Cohort', 'description': 'Control patients had a primary infection and serologic tests that were conducted between the primary infection and the index date. A control patient could be matched to more than one case patient if they had more than one eligible serologic test. Case patients were 1:20 matched to controls.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '1034'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '1034'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited into a cohort from the health plan membership from June 2020 to March 2021 using text message and emails linked to online consent documents. From this cohort, we conducted a nested case control analysis in which participants with the outcome were compared to participants without the outcome.', 'preAssignmentDetails': 'As is standard in a nested case-control study, the cohort is used to identify a sufficient sample to conduct the case-control analysis, in which people with the outcome of interest are compared with people who did not have the outcome. The protocol section describes the recruited cohort (n=4235) and the results section describe participants in the case-control (n=1114). Participants not in the case-control (n=3121) are not in the participant flow because their data were not analyzed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '1034', 'groupId': 'BG001'}, {'value': '1114', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Case Patients Nested Within the Cohort', 'description': 'Case patients had a reinfection, defined as a positive SARS-CoV-2 RNA test ≥ 90 days after the first positive RNA. Case patients had serology completed between the infections.'}, {'id': 'BG001', 'title': 'Control Patients Nested Within the Cohort', 'description': 'Control patients had a primary infection and serologic tests that were conducted between the primary infection and the index date. A control patient could be matched to more than one case patient if they had more than one eligible serologic test. Case patients were 1:20 matched to controls.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.7', 'spread': '12.7', 'groupId': 'BG000'}, {'value': '54.4', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '54.3', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '761', 'groupId': 'BG001'}, {'value': '821', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '782', 'groupId': 'BG001'}, {'value': '830', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Negative serologic test', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The analysis population is cases (n=80) and controls (n=1034) within a cohort (n=4235).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-01', 'size': 275793, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-31T16:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4235}, 'targetDuration': '10 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2022-05-05', 'resultsFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2022-05-05', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-29', 'studyFirstPostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reinfection With SARS-CoV-2', 'timeFrame': 'Through the completion of the study analytic period, an average of 6 months', 'description': 'In this case-control analysis, case patients were participants with the outcome of reinfection. The date of reinfection was the index date. Control patients were those with a primary infection but without the outcome reinfection by the index date. The case and control participants were compared with respect to a seronegative test result (exposure) after primary infection and closest in time to the index date. Because the cases and controls were selected on the basis of the outcome, the seronegative result is listed below by case and control status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2'], 'conditions': ['COVID-19 Testing']}, 'referencesModule': {'references': [{'pmid': '38205171', 'type': 'RESULT', 'citation': 'Binswanger IA, Narwaney KJ, Barrow JC, Albers KB, Bechtel L, Steiner CA, Ann Shoup J, Glanz JM. Association between severe acute respiratory syndrome coronavirus 2 antibody status and reinfection: A case-control study nested in a Colorado-based prospective cohort study. Prev Med Rep. 2023 Dec 1;37:102530. doi: 10.1016/j.pmedr.2023.102530. eCollection 2024 Jan.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.pmedr.2023.102530', 'label': 'Publication'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to establish a cohort of Kaiser Permanente Colorado (KPCO) members who have and have not had COVID-19 infection for serial antibody testing and PCR testing to:\n\n1. Quantify antibody titers among participants over 9 months.\n2. Determine the rates of asymptomatic, mild, and severe recurrent infection among participants with prior COVID-19.\n3. Examine association between antibody titer levels and risk of recurrent infection using a case control analysis nested in the cohort.', 'detailedDescription': 'In this study, the Kaiser Permanente Colorado (KPCO) Institute for Health Research (IHR) will evaluate SARS-CoV-2 IgG antibody titers over time among individuals with evidence of prior infection, and correlate antibody titers with risk of recurrent infection. The investigators will identify KPCO members who have and have not had prior infection, enroll them into a cohort study, conduct serial surveys for new COVID-19 symptoms, and facilitate serial viral and antibody testing.\n\nAll laboratory testing procedures and clinical management of participants will be conducted by KPCO operations. The research team will identify participants, obtain consent, administer surveys to assess COVID-19 symptoms, and direct patients to the appropriate testing. Health outcomes on cohort participants will be tracked with survey data on symptoms, clinical and utilization data from the KPCO electronic health record (e.g., hospitalization), and laboratory data (e.g., viral test results).\n\nThis research-operations partnership strategy will generate data to better understand the implications of positive antibody titers to this novel pathogen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The study cohort will include individuals who are enrolled in Kaiser Permanente Colorado's health plan. Individuals will be selected who have evidence of prior SARS CoV-2 infection and random samples of the general KPCO membership of similar demographic characteristics who appear not to have had SARS CoV-2 infection.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria are Kaiser Permanente Colorado health plan members, with a valid email address or phone number in the electronic health record and not on the Do Not Call List for research.'}, 'identificationModule': {'nctId': 'NCT05365750', 'briefTitle': 'COVID-19 Antibody and Reinfection Study', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'COVID-19 Antibody and Reinfection Study', 'orgStudyIdInfo': {'id': '1589316-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case', 'description': "Case patients were drawn from a random sample of individuals who were enrolled in KPCO's health plan had suspected or confirmed SARS-CoV-2 infection and a random stratified sample of the general KPCO membership with similar age, gender, race/ethnicity and co-morbidities as case group. Within the cohort, case patients had a SARS-CoV-reinfection, defined as a positive SARS-CoV-2 RNA test ≥ 90 days after the first positive RNA test."}, {'label': 'Control', 'description': "Control patients were drawn from a random sample of individuals who were enrolled in KPCO's health plan had suspected or confirmed SARS-CoV-2 infection and a random stratified sample of the general KPCO membership with similar age, gender, race/ethnicity and co-morbidities as case group. Within the cohort, control patients had no evidence of a SARS-CoV-reinfection during the period of interest."}]}, 'contactsLocationsModule': {'locations': [{'zip': '80014', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Ingrid Binswanger, MD, MPH, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Investigator', 'investigatorFullName': 'Ingrid Binswanger', 'investigatorAffiliation': 'Kaiser Permanente'}}}}