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

Purpose

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

  • COVID-19

Eligibility

Eligible Ages
Under 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Completed
Sponsor
Hoffmann-La Roche

Study Contact