Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-25 @ 2:35 PM
Study NCT ID:
NCT04377750
Status:
UNKNOWN
Last Update Posted:
2020-05-06
First Post:
2020-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Tocilizumab in the Management of Patients Who Have Severe COVID-19 With Suspected Pulmonary Hyperinflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080424', 'term': 'Cytokine Release Syndrome'}], 'ancestors': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-05-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-05', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-05-05', 'lastUpdatePostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'One-month', 'description': 'One-month mortality rate .'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'Cytokine storm', 'IL-6'], 'conditions': ['Covid19 Pneumonia']}, 'descriptionModule': {'briefSummary': 'Title: The use of Tocilizumab in the management of patients who have severe COVID-19 with suspected pulmonary hyperinflammation.\n\nThis is a study designed to assess the therapeutic value of intravenous tocilizumab administered as single 8mg/Kg dose in patients affected by SARS-CoV2 infection with a pulmonary manifestation causing hypoxia. Aim of the study is to test the hypothesis that anti-IL6 treatment can be effective in reducing the virus-induced cytokine storm, blocking deterioration of lung function or even promoting a rapid improvement of clinical conditions, preventing tracheal intubation and/or death.\n\nThis drug will be administered to those patients entering the ICU with severe acute respiratory failure COVID-19 disease. The endpoints are death and duration of hospitalization. The patients will be assessed with surrogate markers determining the level of the cytokine storm.', 'detailedDescription': 'Study design This is a multicenter, two arms, 2:1 (treatment: control) open-label randomized control study with a drug approved for another indication in Israel. All the patients enrolled will be treated with tocilizumab or not. One-month mortality rate is the primary endpoint. One arm will be the study drug anti-IL6R (Tocilizumab (Actmera)) 8 mg/kg given IV during one hour once. The placebo will be a 100 ml saline IV infusion administered along one hour.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Any gender\n2. Age 18 and older\n3. Informed consent for participation in the study\n4. Virological diagnosis of Sars-CoV2 infection (PCR)\n5. Acute respiratory failure\n6. Radiographic pneumonia, defined as any/ changing new lung infiltrate\n7. Patient breathing spontaneously, required more than 50% oxygen and MEWS score \\> 7.\n8. If intubated, intubated less than 24 hours with PaO2/Fio2 ratio ≤ 200 and PEEP ≥ 5 cm H2O.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to tocilizumab or its excipients\n2. Patient with a life expectancy of less than 6 months.\n3. Known active infections or other clinical condition that contra-indicate tocilizumab and cannot be treated or solved according to the judgement of the clinician.\n4. Neutrophils \\<500 / mmc\n5. Platelets \\<40.000 / mmc'}, 'identificationModule': {'nctId': 'NCT04377750', 'briefTitle': 'The Use of Tocilizumab in the Management of Patients Who Have Severe COVID-19 With Suspected Pulmonary Hyperinflammation', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'The Use of Tocilizumab in the Management of Patients Who Have Severe COVID-19 With Suspected Pulmonary Hyperinflammation', 'orgStudyIdInfo': {'id': '0224-20-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tocilizumab treatment group', 'description': 'Treatment: intravenous administration of monoclonal anti body anti- IL6R. The dose is 8 mg/kg up to total dose of 800 mg.', 'interventionNames': ['Drug: Tocilizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo. intravenous administration of 100 ml of normal saline.', 'interventionNames': ['Drug: Tocilizumab']}], 'interventions': [{'name': 'Tocilizumab', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'The placebo treatment arm will include 100 ml of normal saline administered along 60 min', 'armGroupLabels': ['Placebo group', 'Tocilizumab treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'state': 'Please Select:', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Eithan Galun, Prof.', 'role': 'CONTACT', 'email': 'eithang@hadassah.org.il', 'phone': '972-2-6777762'}], 'facility': 'Hadassah Medical Orginisation', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Ashkelon', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Shlomo Maayan, PROF', 'role': 'CONTACT', 'email': 'shlomomom@bmc.gov.il', 'phone': '972-5-37678965'}], 'facility': 'Barzilai Medical Center', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}, {'city': 'Holon', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yasmin Meir, Dr.', 'role': 'CONTACT', 'email': 'yasminm@wmc.gov.il', 'phone': '972-5-26666194'}], 'facility': 'Wolfson Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}, {'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Galia Rahav, Prof.', 'role': 'CONTACT', 'email': 'galia.rahav@sheba.health.gov.il', 'phone': '972-5-526666190'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Reuven Pizov, Prof.', 'role': 'CONTACT', 'email': 'pizovr@hadassah.org.il', 'phone': '972-50-6265542'}, {'name': 'Eithan Galun, Prof.', 'role': 'CONTACT', 'email': 'eithang@hadassah.org.il', 'phone': '972-2-6777762'}], 'overallOfficials': [{'name': 'Juli Benbenisty, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Hadassah Medical Organization'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}