Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-30 @ 11:10 AM
Study NCT ID:
NCT05663957
Status:
COMPLETED
Last Update Posted:
2024-09-03
First Post:
2022-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
eVusheld Assessment reaL wORld Effectiveness in the VA Health System
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': 'C000714168', 'term': 'cilgavimab and tixagevimab drug combination'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5814}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2022-09-22', 'studyFirstSubmitQcDate': '2022-12-15', 'lastUpdatePostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospitalization due to COVID-19', 'timeFrame': 'up to 6 months', 'description': 'Hospital record of patient admission'}, {'measure': 'All-cause mortality', 'timeFrame': 'Up to 6 months', 'description': 'All-cause deaths'}], 'secondaryOutcomes': [{'measure': 'Documented SARS-COV-2 infection', 'timeFrame': 'up to 6 and 12 months', 'description': 'Any positive SARS-CoV-2 diagnostic test (eg, PCR, nucleic acid amplification, antigen) OR medical encounter resulting in a diagnosis code for COVID-19b OR medical encounter resulting in a code for isolation due to COVID-19'}, {'measure': 'Medically attended COVID-19', 'timeFrame': 'up to 6 and 12 months', 'description': 'COVID-19 or SARS-CoV-2 infection leading to consultation of a healthcare professional'}, {'measure': 'COVID-19 hospitalisation', 'timeFrame': 'up to 12 months', 'description': 'Hospitalisation due to COVID-19'}, {'measure': 'COVID-19 Intensive Care Unit (ICU) admisssion', 'timeFrame': 'up to 6 and 12 months', 'description': 'ICU admission due to COVID-19'}, {'measure': 'COVID-19-related mortality', 'timeFrame': 'up to 6 and 12 months', 'description': 'Death due to COVID-19'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EVUSHELD', 'tixagevimab and cilgavimab', 'Pre-exposure prophylaxis', 'COVID-19', 'SARS-CoV-2', 'Effectiveness'], 'conditions': ['SARS-CoV-2, COVID-19']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8850R00014&attachmentIdentifier=06433158-0943-47b5-b6bc-165bcc2e5abb&fileName=Redacted_CSR_Synopsis_D8850R00014.pdf&versionIdentifier=', 'label': 'Redacted CSR Synopsis D8850R00014'}]}, 'descriptionModule': {'briefSummary': 'An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the Department of Veterans Affairs (VA) Health System.', 'detailedDescription': 'This a Phase IV observational, secondary data study to assess the effectiveness of Evusheld in preventing COVID-19 infection and severe outcomes using the electronic medical records from the nationwide integrated health system.\n\nThe study is designed as an AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the VA Health System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All EUA-eligible immunocompromised patient population in the Department of Veterans Affairs Health System.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Receipt of EVUSHELD under the FDA EUA for EVUSHELD\n2. Eligibility to access EVUSHELD use under the EUA.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05663957', 'acronym': 'VALOR-VA', 'briefTitle': 'eVusheld Assessment reaL wORld Effectiveness in the VA Health System', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Observational Study to Assess the Real-World Effectiveness of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among EVUSHELD-eligible Populations Receiving Care in VA Health System in the United States', 'orgStudyIdInfo': {'id': 'D8850R00014'}, 'secondaryIdInfos': [{'id': 'D8850R00014', 'type': 'OTHER', 'domain': 'AstraZeneca'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'EVUSHELD arm', 'description': 'Individuals given EVUSHELD for prophylaxis', 'interventionNames': ['Drug: Evusheld']}, {'label': 'Concurrent Control arm', 'description': 'Individuals eligible for Evusheld prophylaxis but did not receive EVUSHELD'}], 'interventions': [{'name': 'Evusheld', 'type': 'DRUG', 'description': 'EVUSHELD users', 'armGroupLabels': ['EVUSHELD arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84148-0001', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Scott L DuVall, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Informatics and Computing Infrastructure (VINCI)'}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.\n\nAll request will be evaluated as per the AZ disclosure commitment:\n\nhttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.\n\nURL:'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'VA Informatics and Computing Infrastructure (VINCI)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}