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A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase Ib, Single-Arm, Open-Label Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab in Pediatric Patients Hospitalized With COVID-19

NCT05164133•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

0 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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)

Locations (25)

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

Key Dates

Start Date

June 10, 2022

Primary Completion Date

March 27, 2024

Completion Date

March 27, 2024

Last Updated

April 29, 2024

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

Tocilizumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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