Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-10 @ 2:58 PM
Study NCT ID:
NCT04701658
Status:
COMPLETED
Last Update Posted:
2021-11-16
First Post:
2021-01-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was originally designed to include a matched control arm. However, due to low enrollment, it was amended to be a single arm study with Bamlanivimab arm only. No matched controls were utilized. Therefore, no comparative analyses were conducted. All analyses were descriptive in nature and conducted only on Bamlanivimab-treated participants.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline through Follow-up (Up to 90 days)', 'description': 'All participants who received single dose of Bamlanivimab.', 'eventGroups': [{'id': 'EG000', 'title': 'Bamlanivimab 700 mg', 'description': 'Participants received 700 mg single IV infusion of Bamlanivimab.', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 9, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Paranasal sinus hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pharyngeal swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'End stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bamlanivimab 700 mg', 'description': 'Participants received 700 mg single IV infusion of Bamlanivimab.'}], 'classes': [{'title': 'Baseline through Day 29', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.7'}]}]}, {'title': 'Baseline through Day 60', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.7'}]}]}, {'title': 'Baseline through Day 90', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Days 29, 60, and 90', 'description': 'Percentage of Participants who Experience COVID-19 Related Hospitalization or Death From Any Cause. Hospitalization is defined as ≥24 hours of acute care.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received single dose of Bamlanivimab.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a COVID-19-related Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bamlanivimab 700 mg', 'description': 'Participants received 700 mg single IV infusion of Bamlanivimab.'}], 'classes': [{'title': 'Baseline through Day 29', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.7'}]}]}, {'title': 'Baseline through Day 60', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.7'}]}]}, {'title': 'Baseline through Day 90', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Days 29, 60, and 90', 'description': 'Hospitalization is defined as ≥24 hours of acute care.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received single dose of Bamlanivimab.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a COVID-related Emergency Department (ED) Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bamlanivimab 700 mg', 'description': 'Participants received 700 mg single IV infusion of Bamlanivimab.'}], 'classes': [{'title': 'Baseline through Day 29', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '9.8'}]}]}, {'title': 'Baseline through Day 60', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '9.8'}]}]}, {'title': 'Baseline through Day 90', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '9.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Days 29, 60, and 90', 'description': 'Percentage of Participants with a COVID-related ED Visit.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received single dose of Bamlanivimab.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bamlanivimab 700 Milligram (mg)', 'description': 'Participants received 700 mg single intravenous (IV) infusion of Bamlanivimab.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}]}, {'type': 'Received Single Dose of Bamlanivimab', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'The study was originally designed to include a matched control arm. However, due to low enrollment, it was amended to be a single arm study with Bamlanivimab arm only. No matched controls were utilized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Bamlanivimab 700 mg', 'description': 'Participants received 700 mg single IV infusion of Bamlanivimab.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.40', 'spread': '15.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '83', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received single dose of Bamlanivimab.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-18', 'size': 581628, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-29T05:02', 'hasProtocol': True}, {'date': '2021-08-13', 'size': 3336950, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-29T05:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-11', 'studyFirstSubmitDate': '2021-01-07', 'resultsFirstSubmitDate': '2021-11-11', 'studyFirstSubmitQcDate': '2021-01-07', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-11', 'studyFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause', 'timeFrame': 'Baseline through Days 29, 60, and 90', 'description': 'Percentage of Participants who Experience COVID-19 Related Hospitalization or Death From Any Cause. Hospitalization is defined as ≥24 hours of acute care.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a COVID-19-related Hospitalization', 'timeFrame': 'Baseline through Days 29, 60, and 90', 'description': 'Hospitalization is defined as ≥24 hours of acute care.'}, {'measure': 'Percentage of Participants With a COVID-related Emergency Department (ED) Visit', 'timeFrame': 'Baseline through Days 29, 60, and 90', 'description': 'Percentage of Participants with a COVID-related ED Visit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, '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.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/7zjYxdhUwux6y1A18CmrFJ', 'label': 'A Real World Study of Bamlanivimab in Participants With Mild-to-moderate Coronavirus Disease 2019 (COVID-19) (BLAZE-5)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out whether bamlanivimab is able to stop COVID-19 from getting worse. Participants with mild-to-moderate COVID-19 will receive bamlanivimab via an injection into a vein. These participants will be matched to similar COVID-19 patients who received other treatment at a local medical center. All participants will be followed to learn how their disease responds. Participation could last about 3 months and includes two required visits to the study site, with the remainder of assessments performed by phone or by medical record review.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are currently not hospitalized.\n* Have one or more mild or moderate COVID-19 symptoms.\n* Must have first positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral infection determination and as soon as possible within 10 days of symptom onset\n* Are males or non-breastfeeding females.\n* Contraceptive use by males or females should be consistent with local regulations for those participating in clinical studies.\n* Are at high risk for progressing to severe COVID-19 and/or hospitalization.\n\nExclusion Criteria:\n\n* Participants who:\n\n * are hospitalized due to COVID-19, OR\n * require oxygen therapy due to COVID-19, OR\n * require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.\n* Have peripheral capillary oxygen saturation (SpO2) less than or equal to (≤) 90 percent on room air or arterial partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) less than (\\<) 300, respiratory rate greater than or equal to (≥) 30 per minute, heart rate ≥125 per minute.\n* Have body weight \\<40 kilograms.\n* Require mechanical ventilation or anticipated impending need for mechanical ventilation.\n* Have known allergies to any of the components used in the formulation of the interventions.\n* Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention.\n* Have any comorbidity requiring surgery within \\<7 days, or that is considered life-threatening within 29 days.\n* Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.\n* Have a history of a positive SARS-CoV-2 serology test.\n* Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study.\n* Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing.\n* Have received treatment with a SARS-CoV-2-specific monoclonal antibody, remdesivir, or other treatment for COVID-19.\n* Have received convalescent COVID-19 plasma treatment.\n* Have participated in a previous SARS-CoV-2 vaccine study.\n* Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.\n* Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.\n* Are breast-feeding.'}, 'identificationModule': {'nctId': 'NCT04701658', 'acronym': 'BLAZE-5', 'briefTitle': 'A Real World Study of Bamlanivimab in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Prospective Cohort Study to Evaluate the Real-world Effectiveness of Bamlanivimab in Participants With Mild-to-moderate COVID-19 at High Risk for Progressing to Severe Illness, With Matched Controls', 'orgStudyIdInfo': {'id': '18216'}, 'secondaryIdInfos': [{'id': 'J2X-MC-PYAJ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bamlanivimab', 'description': 'Participants received 700 milligram single intravenous infusion of Bamlanivimab.', 'interventionNames': ['Drug: Bamlanivimab']}, {'type': 'NO_INTERVENTION', 'label': 'Controls', 'description': 'Matched controls who received standard of care.\n\n\\[The study was originally designed to include a matched control arm. However, due to low enrollment, it was amended to be a single arm study with Bamlanivimab arm only. No matched controls were utilized.\\]'}], 'interventions': [{'name': 'Bamlanivimab', 'type': 'DRUG', 'otherNames': ['LY3819253', 'LY-CoV555'], 'description': 'Administered intravenously.', 'armGroupLabels': ['Bamlanivimab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87110', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Presbyterian Medical Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'http://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AbCellera Biologics Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}