Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-31 @ 2:23 AM
Study NCT ID:
NCT05164133
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2021-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With 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': 'C502936', 'term': 'tocilizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2021-12-16', 'studyFirstSubmitQcDate': '2021-12-16', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum concentration of TCZ', 'timeFrame': 'Through Day 28'}, {'measure': 'Maximum serum concentration (Cmax) of TCZ', 'timeFrame': 'Through Day 28'}, {'measure': 'Area under the curve from Days 0-28 (AUC days 0-28) of TCZ', 'timeFrame': 'Days 0-28'}, {'measure': 'Serum concentration on Day 28 (C day 28) of TCZ', 'timeFrame': 'Day 28'}, {'measure': 'Clearance (CL) of TCZ', 'timeFrame': 'Through Day 28'}, {'measure': 'Volume of distribution of TCZ', 'timeFrame': 'Through Day 28'}], 'secondaryOutcomes': [{'measure': 'Duration of 90% saturation of sIL-6R', 'timeFrame': 'Through Day 28'}, {'measure': 'Concentration of IL-6', 'timeFrame': 'Through Day 60'}, {'measure': 'Concentration of sIL-6R', 'timeFrame': 'Through Day 60'}, {'measure': 'Concentration of C-reactive protein (CRP)', 'timeFrame': 'Through Day 60'}, {'measure': 'Percentage of participants with adverse events', 'timeFrame': 'Up to 60 days'}, {'measure': 'Percentage of participants with severe adverse events', 'timeFrame': 'Up to 60 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This is a single-arm, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and exploratory efficacy of tocilizumab (TCZ) for the treatment of pediatric patients from birth to less than 18 years old hospitalized with COVID-19 and who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized with COVID-19 confirmed per a positive PCR of any specimen (e.g., respiratory, blood, urine, stool, or other bodily fluid) and evidenced by chest x-ray or CT scan\n* Receiving systemic corticosteroids at baseline\n* Oxygen saturation \\< 93% on room air, or requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) to maintain oxygen saturation \\> 92% at screening and baseline\n\nExclusion Criteria:\n\n* Gestational age \\< 37 weeks\n* Known severe allergic reactions to TCZ or other monoclonal antibodies\n* Active tuberculosis infection\n* Uncontrolled active bacterial, fungal, viral, or other infection (besides COVID-19)\n* Diagnosis or suspected diagnosis of multisystem inflammatory syndrome in children (MIS-C)\n* In the opinion of the investigator, progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments\n* Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months prior to enrollment\n* Treatment with an investigational drug within 5 drug-elimination half-lives or 30 days, whichever is longer, of enrollment (except for anti-SARS-CoV-2 antibodies or directly-acting antivirals)\n* Participating in another interventional drug clinical trial (except for anti-SARS-CoV-2 antibodies or directly-acting antivirals)'}, 'identificationModule': {'nctId': 'NCT05164133', 'briefTitle': 'A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase Ib, Single-Arm, Open-Label Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab in Pediatric Patients Hospitalized With COVID-19', 'orgStudyIdInfo': {'id': 'WA43811'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All Participants', 'description': 'Participants who are hospitalized with COVID-19 and who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation will receive a single dose of TCZ on Day 1, with the option to receive a second dose 8-24 hours later if clinically indicated.', 'interventionNames': ['Drug: Tocilizumab']}], 'interventions': [{'name': 'Tocilizumab', 'type': 'DRUG', 'description': 'Participants will receive intravenous (IV) tocilizumab', 'armGroupLabels': ['All Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Reagan UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48858-3803', 'city': 'Mount Pleasant', 'state': 'Michigan', 'country': 'United States', 'facility': 'Central Michigan University College of Medicine', 'geoPoint': {'lat': 43.59781, 'lon': -84.76751}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Feinstein Institute for Medical Research', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '44106-2624', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77030-3005', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Physicians - Pediatric Center - Texas Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84108-1287', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah - PPDS', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '90020-090', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Santa Casa de Misericordia de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Klinika Za Djecje Bolesti Zagreb', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'University Hospital for Infection Diseases "Dr. Fran Mihaljevic" - PPDS', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHRU Montpellier; SMPEA Peyre Plantade Centre de Ressources Autisme', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hospital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '94275', 'city': 'Val-de-Marne', 'country': 'France', 'facility': 'Assistance Publique Hopitaux de Paris'}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Uniklinik Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '546 42', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Hippokration Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '00165', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '23900', 'city': 'Lecco', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco', 'geoPoint': {'lat': 45.85589, 'lon': 9.39704}}, {'zip': '60-572', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Szpital Kliniczny im Karola Jonschera Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '0001', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Global Clinical Trials Sunnyside', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '08950', 'city': 'Esplugues de Llobregat', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia', 'geoPoint': {'lat': 41.37732, 'lon': 2.08809}}, {'zip': '28009', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infantil Universitario Niño Jesus; Sección de Neuropediatria', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 De Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz - PPDS', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Great North Childrens Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\\_and\\_development/who\\_we\\_are\\_how\\_we\\_work/clinical\\_trials/our\\_commitment\\_to\\_data\\_sharing.htm)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}