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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05164133
• Other study ID #: WA43811
• Status: Completed
• Phase: Phase 1
• Start date: June 10, 2022
• Est. completion date: March 27, 2024

Study information

• Verified date: April 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: March 27, 2024
• Est. primary completion date: March 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Tocilizumab
Participants will receive intravenous (IV) tocilizumab

Locations

Country	Name	City	State
Brazil	Santa Casa de Misericordia de Porto Alegre	Porto Alegre	RS
Croatia	Klinika Za Djecje Bolesti Zagreb	Zagreb
Croatia	University Hospital for Infection Diseases "Dr. Fran Mihaljevic" - PPDS	Zagreb
France	CHRU Montpellier; SMPEA Peyre Plantade Centre de Ressources Autisme	Montpellier
France	Hospital Necker	Paris
France	Assistance Publique Hopitaux de Paris	Val-de-Marne
Germany	Uniklinik Köln	Köln
Germany	Universitätsklinikum Ulm	Ulm
Greece	Hippokration Hospital	Thessaloniki
Italy	ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco	Lecco	Lombardia
Italy	IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN	Roma	Lazio
Poland	Szpital Kliniczny im Karola Jonschera Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu	Poznan
South Africa	Global Clinical Trials Sunnyside	Pretoria
Spain	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
United Kingdom	Great North Childrens Hospital	Newcastle upon Tyne
United States	The University of Chicago	Chicago	Illinois
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	Reagan UCLA Medical Center	Los Angeles	California
United States	Feinstein Institute for Medical Research	Manhasset	New York
United States	Central Michigan University College of Medicine	Mount Pleasant	Michigan
United States	University of Utah - PPDS	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Brazil,  Croatia,  France,  Germany,  Greece,  Italy,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum concentration of TCZ		Through Day 28
Primary	Maximum serum concentration (Cmax) of TCZ		Through Day 28
Primary	Area under the curve from Days 0-28 (AUC days 0-28) of TCZ		Days 0-28
Primary	Serum concentration on Day 28 (C day 28) of TCZ		Day 28
Primary	Clearance (CL) of TCZ		Through Day 28
Primary	Volume of distribution of TCZ		Through Day 28
Secondary	Duration of 90% saturation of sIL-6R		Through Day 28
Secondary	Concentration of IL-6		Through Day 60
Secondary	Concentration of sIL-6R		Through Day 60
Secondary	Concentration of C-reactive protein (CRP)		Through Day 60
Secondary	Percentage of participants with adverse events		Up to 60 days
Secondary	Percentage of participants with severe adverse events		Up to 60 days