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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase Ib, Single-Arm, Open-Label Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab in Pediatric Patients Hospitalized With COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Tocilizumab


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Participants<br>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<br>* Participants will receive intravenous (IV) tocilizumab<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of 90% saturation of sIL-6R |  | Through Day 28 | 
| Concentration of IL-6 |  | Through Day 60 | 
| Concentration of sIL-6R |  | Through Day 60 | 
| Concentration of C-reactive protein (CRP) |  | Through Day 60 | 
| Percentage of participants with adverse events |  | Up to 60 days | 
| Percentage of participants with severe adverse events |  | Up to 60 days |