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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Tocilizumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Reagan UCLA Medical CenterRecruiting
  • Children'S Hospital of Orange County
  • University of Florida Jacksonville
  • The University of ChicagoRecruiting
  • Tulane University Health Sciences Center
  • Central Michigan University College of MedicineRecruiting
  • Saint Louis Children's HospitalRecruiting
  • Feinstein Institute for Medical ResearchRecruiting
  • University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens HospitalRecruiting
  • Rhode Island Hospital
  • UT Physicians - Pediatric Center - Texas Medical CenterRecruiting
  • University of Utah - PPDSRecruiting
  • Santa Casa de Misericordia de Porto AlegreRecruiting
  • Klinika Za Djecje Bolesti ZagrebRecruiting
  • University Hospital for Infection Diseases "Dr. Fran Mihaljevic" - PPDSRecruiting
  • CHRU Montpellier; SMPEA Peyre Plantade Centre de Ressources AutismeRecruiting
  • Hospital NeckerRecruiting
  • Assistance Publique Hopitaux de ParisRecruiting
  • Hippokration HospitalRecruiting
  • IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PINRecruiting
  • ASST di Lecco - Presidio Ospedaliero A. Manzoni di LeccoRecruiting
  • Szpital Kliniczny im Karola Jonschera Uniwersytetu Medycznego im Karola Marcinkowskiego w PoznaniuRecruiting
  • Global Clinical Trials SunnysideRecruiting
  • Hospital Sant Joan de Deu - PIN; Unitat de Recerca - FarmaciaRecruiting
  • Hospital Universitario La Paz - PPDSRecruiting
  • Hospital Infantil Universitario Niño Jesus; Sección de NeuropediatriaRecruiting
  • Hospital Universitario 12 De OctubreRecruiting
  • Great North Childrens HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Participants

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of 90% saturation of sIL-6R
Concentration of IL-6
Concentration of sIL-6R
Concentration of C-reactive protein (CRP)
Percentage of participants with adverse events
Percentage of participants with severe adverse events

Full Information

First Posted
December 16, 2021
Last Updated
October 16, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05164133
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All Participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
Participants will receive intravenous (IV) tocilizumab
Primary Outcome Measure Information:
Title
Serum concentration of TCZ
Time Frame
Through Day 28
Title
Maximum serum concentration (Cmax) of TCZ
Time Frame
Through Day 28
Title
Area under the curve from Days 0-28 (AUC days 0-28) of TCZ
Time Frame
Days 0-28
Title
Serum concentration on Day 28 (C day 28) of TCZ
Time Frame
Day 28
Title
Clearance (CL) of TCZ
Time Frame
Through Day 28
Title
Volume of distribution of TCZ
Time Frame
Through Day 28
Secondary Outcome Measure Information:
Title
Duration of 90% saturation of sIL-6R
Time Frame
Through Day 28
Title
Concentration of IL-6
Time Frame
Through Day 60
Title
Concentration of sIL-6R
Time Frame
Through Day 60
Title
Concentration of C-reactive protein (CRP)
Time Frame
Through Day 60
Title
Percentage of participants with adverse events
Time Frame
Up to 60 days
Title
Percentage of participants with severe adverse events
Time Frame
Up to 60 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: WA43811 https://forpatients.roche.com/
Phone
888-662-6728
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Children'S Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868-3874
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Florida Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Withdrawn
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2632
Country
United States
Individual Site Status
Withdrawn
Facility Name
Central Michigan University College of Medicine
City
Mount Pleasant
State/Province
Michigan
ZIP/Postal Code
48858-3803
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Feinstein Institute for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-2624
Country
United States
Individual Site Status
Recruiting
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903-4801
Country
United States
Individual Site Status
Withdrawn
Facility Name
UT Physicians - Pediatric Center - Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3005
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah - PPDS
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108-1287
Country
United States
Individual Site Status
Recruiting
Facility Name
Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Klinika Za Djecje Bolesti Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
University Hospital for Infection Diseases "Dr. Fran Mihaljevic" - PPDS
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
CHRU Montpellier; SMPEA Peyre Plantade Centre de Ressources Autisme
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Hospital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
Assistance Publique Hopitaux de Paris
City
Val-de-Marne
ZIP/Postal Code
94275
Country
France
Individual Site Status
Recruiting
Facility Name
Hippokration Hospital
City
Thessaloniki
ZIP/Postal Code
546 42
Country
Greece
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
City
Roma
State/Province
Lazio
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco
City
Lecco
State/Province
Lombardia
ZIP/Postal Code
23900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Szpital Kliniczny im Karola Jonschera Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu
City
Poznan
ZIP/Postal Code
60-572
Country
Poland
Individual Site Status
Recruiting
Facility Name
Global Clinical Trials Sunnyside
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz - PPDS
City
Barcelona
ZIP/Postal Code
8041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Infantil Universitario Niño Jesus; Sección de Neuropediatria
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 De Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Great North Childrens Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

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

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