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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Tocilizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 10, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : August 24, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Tocilizumab
Participants will receive intravenous (IV) tocilizumab


Outcome Measures
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Primary Outcome Measures :
  1. Serum concentration of TCZ [ Time Frame: Through Day 28 ]
  2. Maximum serum concentration (Cmax) of TCZ [ Time Frame: Through Day 28 ]
  3. Area under the curve from Days 0-28 (AUC days 0-28) of TCZ [ Time Frame: Days 0-28 ]
  4. Serum concentration on Day 28 (C day 28) of TCZ [ Time Frame: Day 28 ]
  5. Clearance (CL) of TCZ [ Time Frame: Through Day 28 ]
  6. Volume of distribution of TCZ [ Time Frame: Through Day 28 ]

Secondary Outcome Measures :
  1. Duration of 90% saturation of sIL-6R [ Time Frame: Through Day 28 ]
  2. Concentration of IL-6 [ Time Frame: Through Day 60 ]
  3. Concentration of sIL-6R [ Time Frame: Through Day 60 ]
  4. Concentration of C-reactive protein (CRP) [ Time Frame: Through Day 60 ]
  5. Percentage of participants with adverse events [ Time Frame: Up to 60 days ]
  6. Percentage of participants with severe adverse events [ Time Frame: Up to 60 days ]

Eligibility Criteria
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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05164133


Contacts
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Contact: Reference Study ID Number: WA43811 https://forpatients.roche.com/ 888-662-6728 global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05164133    
Other Study ID Numbers: WA43811
First Posted: December 20, 2021    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases