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

NCT05164133 | Completed Phase 1 FDA Drug

• 1 other identifier: WA43811
• Study Type: interventional
• Target: 2
• Locations: 11 countries
• Sites: 25

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• 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

Study Arms (1)

All Participants

EXPERIMENTAL

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

Interventions

Tocilizumab DRUG

Participants will receive intravenous (IV) tocilizumab

All Participants

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (25)

Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Central Michigan University College of Medicine

Mount Pleasant, Michigan, 48858-3803, United States

Location

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106-2624, United States

Location

UT Physicians - Pediatric Center - Texas Medical Center

Houston, Texas, 77030-3005, United States

Location

University of Utah - PPDS

Salt Lake City, Utah, 84108-1287, United States

Location

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Klinika Za Djecje Bolesti Zagreb

Zagreb, 10000, Croatia

Location

University Hospital for Infection Diseases "Dr. Fran Mihaljevic" - PPDS

Zagreb, 10000, Croatia

Location

CHRU Montpellier; SMPEA Peyre Plantade Centre de Ressources Autisme

Montpellier, 34295, France

Location

Hospital Necker

Paris, 75015, France

Location

Assistance Publique Hopitaux de Paris

Val-de-Marne, 94275, France

Location

Uniklinik Köln

Cologne, 50937, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Hippokration Hospital

Thessaloniki, 546 42, Greece

Location

IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN

Rome, Lazio, 00165, Italy

Location

ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco

Lecco, Lombardy, 23900, Italy

Location

Szpital Kliniczny im Karola Jonschera Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu

Poznan, 60-572, Poland

Location

Global Clinical Trials Sunnyside

Pretoria, 0001, South Africa

Location

Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Infantil Universitario Niño Jesus; Sección de Neuropediatria

Madrid, 28009, Spain

Location

Hospital Universitario 12 De Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz - PPDS

Madrid, 28046, Spain

Location

Great North Childrens Hospital

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: December 20, 2021
• Study Start: June 10, 2022
• Primary Completion: March 27, 2024
• Study Completion: March 27, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (3); PL (1); IT (2); GB (1); BR (1); GR (1); DE (2); CR (2); ZA (1); US (7); ES (4)