Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT04377659
Status:
TERMINATED
Last Update Posted:
2025-05-28
First Post:
2020-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'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': 'C502936', 'term': 'tocilizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gyurkocb@mskcc.org', 'phone': '646-608-3768', 'title': 'Dr. Boglarka Gyurkocza, MD', 'organization': 'Memorial Sloan Kettering Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Intubation/Mechanical Ventilation', 'description': 'Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation\n\nTocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Respiratory Support', 'description': 'In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)\n\nTocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 3, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Thromboembolic Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White Blood Cell Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocyte Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infecions and Infestations - Other, specify - Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression of Respiratory Failure or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intubation/Mechanical Ventilation', 'description': 'Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation\n\nTocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.'}, {'id': 'OG001', 'title': 'Respiratory Support', 'description': 'In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)\n\nTocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.'}], 'timeFrame': '14 days', 'description': 'The primary endpoint for this cohort is progression of respiratory failure (binary yes/no while hospitalized). Progression of respiratory failure will be defined as a sustained increase in oxygen requirement (FiO2) or need for intubation/mechanical ventilation.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intubation/Mechanical Ventilation', 'description': 'Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation\n\nTocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.'}, {'id': 'FG001', 'title': 'Respiratory Support', 'description': 'In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)\n\nTocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intubation/Mechanical Ventilation', 'description': 'Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation\n\nTocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.'}, {'id': 'BG001', 'title': 'Respiratory Support', 'description': 'In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)\n\nTocilizumab: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000', 'lowerLimit': '62', 'upperLimit': '73'}, {'value': '74', 'groupId': 'BG001', 'lowerLimit': '64', 'upperLimit': '87'}, {'value': '73', 'groupId': 'BG002', 'lowerLimit': '62', 'upperLimit': '87'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', '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': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-16', 'size': 792902, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-09T14:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Based on two large, multicenter, randomized trials showed no benefit to tocilizumab in this setting and study has been closed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2020-05-04', 'resultsFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-09', 'studyFirstPostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression of Respiratory Failure or Death', 'timeFrame': '14 days', 'description': 'The primary endpoint for this cohort is progression of respiratory failure (binary yes/no while hospitalized). Progression of respiratory failure will be defined as a sustained increase in oxygen requirement (FiO2) or need for intubation/mechanical ventilation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVD-19', 'Tocilizumab', 'Respiratory infection', '20-185', 'Memorial Sloan Kettering Cancer Center'], 'conditions': ['COVID-19']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient or designated proxy willing and able to provide informed consent prior to enrollment in the study.\n* COVID-19 PCR positive on nasopharyngeal swab\n* Aged \\>/= 18 years old\n* Patient hospitalized with newly diagnosed documented severe COVID-19 infection: with respiratory rate \\>/= 30 breaths/min OR peripheral capillary oxygen saturation (SpO2) \\< 93% on room air for nonintubated pts.\n* Fever of 38.5 C or suspected respiratory infection\n* IL-6 level \\>/= 80 pcg/ml\n* Cohort #1 - non intubated Cohort #2 - intubated\n* Women of childbearing potential must have a negative serum or urine pregnancy test\n* Patients receiving ongoing steroid therapy are eligible\n* Patients will be allowed to receive concurrent or sequential treatment with remdesivir\n\nExclusion Criteria:\n\n* Patients with uncontrolled systemic fungal and bacterial infections\n* Patients with latent tuberculosis\n* Patients with known hypersensitivity to tocilizumab or any component of the formulation\n* Concurrent initiation of steroid therapy is not allowed\n* Patients with uncrontroled malignant disease, with a life expectancy of 3 months or less'}, 'identificationModule': {'nctId': 'NCT04377659', 'briefTitle': 'Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'A Phase II Study of IL-6 Receptor Antagonist Tocilizumab to Prevent Respiratory Failure and Death in Patients With Severe COVID-19 Infection', 'orgStudyIdInfo': {'id': '20-185'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intubation/Mechanical Ventilation', 'description': 'Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation', 'interventionNames': ['Drug: Tocilizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Respiratory Support', 'description': 'In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)', 'interventionNames': ['Drug: Tocilizumab']}], 'interventions': [{'name': 'Tocilizumab', 'type': 'DRUG', 'description': 'Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.', 'armGroupLabels': ['Intubation/Mechanical Ventilation', 'Respiratory Support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Boglarka Gyurkocza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}