Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT04603651
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2023-10-02
First Post:
2020-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanded Access Program to Provide Bamlanivimab (LY3819253) for the Treatment of COVID-19
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': 'C000711749', 'term': 'bamlanivimab'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09-15', 'lastUpdateSubmitDate': '2023-09-29', 'studyFirstSubmitDate': '2020-10-23', 'studyFirstSubmitQcDate': '2020-10-23', 'lastUpdatePostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '34473343', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Reside in a country where there are ongoing Lilly-sponsored clinical trials (currently this is only the United States)\n* Present within 10 days of symptom onset\n* Have severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) confirmed by reverse transcription polymerase chain reaction (RT-PCR) within the last three days\n* Participants greater than or equal to (≥) 65 years of age OR\n* Participants ≥ 12 years of age who weigh at least 40 kilograms AND have at least one of the following:\n\n * Cancer\n * Chronic kidney disease\n * Chronic obstructive pulmonary disease (COPD) or other chronic lung disease\n * Immunocompromised state (weakened immune system or on immunomodulatory medications)\n * Obesity (body mass index \\[BMI\\] of 35 or higher)\n * Serious heart conditions such as heart failure, coronary artery disease or cardiomyopathies\n * Sickle cell disease\n * Diabetes mellitus (Types 1 or 2)\n\nExclusion Criteria:\n\n* Require hospitalization greater than (\\>) 24 hours or hospice care. Residents in long term care or skilled nursing facilities that meet the inclusion criteria and are not on mechanical ventilation will be considered\n* Bamlanivimab should not be used in patients hospitalized with severe COVID-19 respiratory disease'}, 'identificationModule': {'nctId': 'NCT04603651', 'briefTitle': 'Expanded Access Program to Provide Bamlanivimab (LY3819253) for the Treatment of COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Expanded Access Information for Physicians for Bamlanivimab (LY3819253) Emergency Investigational New Drug [EIND]', 'orgStudyIdInfo': {'id': '18165'}, 'secondaryIdInfos': [{'id': 'J2X-MC-Y001', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Bamlanivimab', 'type': 'DRUG', 'otherNames': ['LY3819253', 'LY-CoV555'], 'description': 'Administered intravenously (IV).'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Contact Lilly at 1-800-LillyRx (1-800-545-5979)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AbCellera Biologics Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}