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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Tocilizumab

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90020-090
      • Santa Casa de Misericórdia de Porto Alegre
• Croatia
  • Zagreb, Croatia, 10000
    • Klinika Za Djecje Bolesti Zagreb
  • Zagreb, Croatia, 10000
    • University Hospital for Infection Diseases "Dr. Fran Mihaljevic" - PPDS
• France
  • Montpellier, France, 34295
    • CHRU Montpellier; SMPEA Peyre Plantade Centre de Ressources Autisme
  • Paris, France, 75015
    • Hospital Necker
  • Val-de-Marne, France, 94275
    • Assistance Publique Hopitaux De Paris
• Germany
  • Köln, Germany, 50937
    • Uniklinik Köln
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm
• Greece
  • Thessaloniki, Greece, 546 42
    • Hippokration Hospital
• Italy
  • Lazio
    • Roma, Lazio, Italy, 00165
      • IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN
  • Lombardia
    • Lecco, Lombardia, Italy, 23900
      • ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco
• Poland
  • Poznan, Poland, 60-572
    • Szpital Kliniczny im Karola Jonschera Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu
• South Africa
  • Pretoria, South Africa, 0001
    • Global Clinical Trials Sunnyside
• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz - PPDS
  • Madrid, Spain, 28009
    • Hospital Infantil Universitario Niño Jesus; Sección de Neuropediatria
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia
• United Kingdom
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Great North Childrens Hospital
• United States
  • California
    • Los Angeles, California, United States, 90095
      • Reagan UCLA Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago
  • Michigan
    • Mount Pleasant, Michigan, United States, 48858-3803
      • Central Michigan University College of Medicine
  • New York
    • Manhasset, New York, United States, 11030
      • Feinstein Institute for Medical Research
  • Ohio
    • Cleveland, Ohio, United States, 44106-2624
      • University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital
  • Texas
    • Houston, Texas, United States, 77030-3005
      • UT Physicians - Pediatric Center - Texas Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84108-1287
      • University of UTAH - PPDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Tocilizumab; Participants will receive intravenous (IV) tocilizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum concentration of TCZ	Through Day 28
Maximum serum concentration (Cmax) 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
Clearance (CL) of TCZ	Through Day 28
Volume of distribution of TCZ	Through Day 28

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Actual): March 27, 2024
• Study Completion (Actual): March 27, 2024

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: WA43811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No