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

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ClinicalTrials.gov Identifier: NCT05164133
Recruitment Status : Recruiting
First Posted : December 20, 2021
Last Update Posted : March 13, 2023
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE December 16, 2021
First Posted Date  ICMJE December 20, 2021
Last Update Posted Date March 13, 2023
Actual Study Start Date  ICMJE June 10, 2022
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2021)
  • Serum concentration of TCZ [ Time Frame: Through Day 28 ]
  • Maximum serum concentration (Cmax) of TCZ [ Time Frame: Through Day 28 ]
  • Area under the curve from Days 0-28 (AUC days 0-28) of TCZ [ Time Frame: Days 0-28 ]
  • Serum concentration on Day 28 (C day 28) of TCZ [ Time Frame: Day 28 ]
  • Clearance (CL) of TCZ [ Time Frame: Through Day 28 ]
  • Volume of distribution of TCZ [ Time Frame: Through Day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2021)
  • Duration of 90% saturation of sIL-6R [ Time Frame: Through Day 28 ]
  • Concentration of IL-6 [ Time Frame: Through Day 60 ]
  • Concentration of sIL-6R [ Time Frame: Through Day 60 ]
  • Concentration of C-reactive protein (CRP) [ Time Frame: Through Day 60 ]
  • Percentage of participants with adverse events [ Time Frame: Up to 60 days ]
  • Percentage of participants with severe adverse events [ Time Frame: Up to 60 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19
Official Title  ICMJE A Phase Ib, Single-Arm, Open-Label Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab in Pediatric Patients Hospitalized With COVID-19
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Drug: Tocilizumab
Participants will receive intravenous (IV) tocilizumab
Study Arms  ICMJE 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.
Intervention: Drug: Tocilizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2021)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 24, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: WA43811 https://forpatients.roche.com/ 888-662-6728 global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Croatia,   France,   Greece,   Italy,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05164133
Other Study ID Numbers  ICMJE WA43811
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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).
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date March 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP