A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19
NCT ID: NCT05164133
Last Updated: 2024-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
2 participants
INTERVENTIONAL
2022-06-10
2024-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All Participants
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.
Tocilizumab
Participants will receive intravenous (IV) tocilizumab
Interventions
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Tocilizumab
Participants will receive intravenous (IV) tocilizumab
Eligibility Criteria
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Inclusion Criteria
* Receiving systemic corticosteroids at baseline
* 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
Exclusion Criteria
* Known severe allergic reactions to TCZ or other monoclonal antibodies
* Active tuberculosis infection
* Uncontrolled active bacterial, fungal, viral, or other infection (besides COVID-19)
* Diagnosis or suspected diagnosis of multisystem inflammatory syndrome in children (MIS-C)
* In the opinion of the investigator, progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments
* Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months prior to enrollment
* 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)
* Participating in another interventional drug clinical trial (except for anti-SARS-CoV-2 antibodies or directly-acting antivirals)
17 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Reagan UCLA Medical Center
Los Angeles, California, United States
The University of Chicago
Chicago, Illinois, United States
Central Michigan University College of Medicine
Mount Pleasant, Michigan, United States
Feinstein Institute for Medical Research
Manhasset, New York, United States
University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States
UT Physicians - Pediatric Center - Texas Medical Center
Houston, Texas, United States
University of Utah - PPDS
Salt Lake City, Utah, United States
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Klinika Za Djecje Bolesti Zagreb
Zagreb, , Croatia
University Hospital for Infection Diseases "Dr. Fran Mihaljevic" - PPDS
Zagreb, , Croatia
CHRU Montpellier; SMPEA Peyre Plantade Centre de Ressources Autisme
Montpellier, , France
Hospital Necker
Paris, , France
Assistance Publique Hopitaux de Paris
Val-de-Marne, , France
Uniklinik Köln
Cologne, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Hippokration Hospital
Thessaloniki, , Greece
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Rome, Lazio, Italy
ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco
Lecco, Lombardy, Italy
Szpital Kliniczny im Karola Jonschera Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu
Poznan, , Poland
Global Clinical Trials Sunnyside
Pretoria, , South Africa
Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia
Esplugues de Llobregat, Barcelona, Spain
Hospital Infantil Universitario Niño Jesus; Sección de Neuropediatria
Madrid, , Spain
Hospital Universitario 12 De Octubre
Madrid, , Spain
Hospital Universitario La Paz - PPDS
Madrid, , Spain
Great North Childrens Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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Other Identifiers
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WA43811
Identifier Type: -
Identifier Source: org_study_id
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