Clinical trial NCT05164133: A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2021-12-20
Enrollment: 2
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Serum concentration of TCZ
timeFrame: Through Day 28
measure: Maximum serum concentration (Cmax) of TCZ
timeFrame: Through Day 28
measure: Area under the curve from Days 0-28 (AUC days 0-28) of TCZ
timeFrame: Days 0-28
measure: Serum concentration on Day 28 (C day 28) of TCZ
timeFrame: Day 28
measure: Clearance (CL) of TCZ
timeFrame: Through Day 28
measure: Volume of distribution of TCZ
timeFrame: Through Day 28
Secondary outcomes:
measure: Duration of 90% saturation of sIL-6R
timeFrame: Through Day 28
measure: Concentration of IL-6
timeFrame: Through Day 60
measure: Concentration of sIL-6R
timeFrame: Through Day 60
measure: Concentration of C-reactive protein (CRP)
timeFrame: Through Day 60
measure: Percentage of participants with adverse events
timeFrame: Up to 60 days
measure: Percentage of participants with severe adverse events
timeFrame: Up to 60 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Reagan UCLA Medical Center
state: California
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Mount Pleasant
country: United States
facility: Central Michigan University College of Medicine
state: Michigan
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital
state: Ohio
city: Houston
country: United States
facility: UT Physicians - Pediatric Center - Texas Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah - PPDS
state: Utah
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericordia de Porto Alegre
state: RS
city: Zagreb
country: Croatia
facility: Klinika Za Djecje Bolesti Zagreb
city: Zagreb
country: Croatia
facility: University Hospital for Infection Diseases "Dr. Fran Mihaljevic" - PPDS
city: Montpellier
country: France
facility: CHRU Montpellier; SMPEA Peyre Plantade Centre de Ressources Autisme
city: Paris
country: France
facility: Hospital Necker
city: Val-de-Marne
country: France
facility: Assistance Publique Hopitaux de Paris
city: Köln
country: Germany
facility: Uniklinik Köln
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Thessaloniki
country: Greece
facility: Hippokration Hospital
city: Roma
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
state: Lazio
city: Lecco
country: Italy
facility: ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco
state: Lombardia
city: Poznan
country: Poland
facility: Szpital Kliniczny im Karola Jonschera Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu
city: Pretoria
country: South Africa
facility: Global Clinical Trials Sunnyside
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesus; Sección de Neuropediatria
city: Madrid
country: Spain
facility: Hospital Universitario 12 De Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz - PPDS
city: Newcastle upon Tyne
country: United Kingdom
facility: Great North Childrens Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: