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

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Drug: Tocilizumab

• Registration Number: NCT05164133
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2021-12-20
• Study Start: 2022-06-10
• Primary Completion: 2024-03-27
• Study Completion: 2024-03-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Participants	Tocilizumab	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.

Primary Outcome Measures

Name	Time	Method
Clearance (CL) of TCZ	Through Day 28
Maximum serum concentration (Cmax) of TCZ	Through Day 28
Serum concentration of TCZ	Through Day 28
Area under the curve from Days 0-28 (AUC days 0-28) of TCZ	Days 0-28
Serum concentration on Day 28 (C day 28) of TCZ	Day 28
Volume of distribution of TCZ	Through Day 28

Secondary Outcome Measures

Name	Time	Method
Duration of 90% saturation of sIL-6R	Through Day 28
Concentration of C-reactive protein (CRP)	Through Day 60
Percentage of participants with severe adverse events	Up to 60 days
Concentration of IL-6	Through Day 60
Concentration of sIL-6R	Through Day 60
Percentage of participants with adverse events	Up to 60 days

Trial Locations

Locations (25)

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

Great North Childrens Hospital; 🇬🇧 Newcastle upon Tyne, United Kingdom

Santa Casa de Misericordia de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil

University Hospital for Infection Diseases "Dr. Fran Mihaljevic" - PPDS; 🇭🇷 Zagreb, Croatia

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Hippokration Hospital; 🇬🇷 Thessaloniki, Greece

IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN; 🇮🇹 Roma, Lazio, Italy

ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco; 🇮🇹 Lecco, Lombardia, Italy

Szpital Kliniczny im Karola Jonschera Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu; 🇵🇱 Poznan, Poland

The University of Chicago; 🇺🇸 Chicago, Illinois, United States

UT Physicians - Pediatric Center - Texas Medical Center; 🇺🇸 Houston, Texas, United States

Assistance Publique Hopitaux de Paris; 🇫🇷 Val-de-Marne, France

University of Utah - PPDS; 🇺🇸 Salt Lake City, Utah, United States

Central Michigan University College of Medicine; 🇺🇸 Mount Pleasant, Michigan, United States

CHRU Montpellier; SMPEA Peyre Plantade Centre de Ressources Autisme; 🇫🇷 Montpellier, France

Klinika Za Djecje Bolesti Zagreb; 🇭🇷 Zagreb, Croatia

Hospital Necker; 🇫🇷 Paris, France

Uniklinik Köln; 🇩🇪 Köln, Germany

Reagan UCLA Medical Center; 🇺🇸 Los Angeles, California, 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

Hospital Universitario La Paz - PPDS; 🇪🇸 Madrid, Spain