A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19

Completed · Phase 1

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT05164133

Run by

Hoffmann-La Roche

People needed

2

Starts

2022-06-10

Expected to finish

2024-03-27

Last updated by the study team

2024-04-29

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• Gestational age < 37 weeks
• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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