COVID-19
Conditions
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.
Interventions
DRUGTocilizumab
Participants will receive intravenous (IV) tocilizumab
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Volume of distribution of TCZ | Through Day 28 |
| 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 |
Secondary
| Measure | 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 |
Countries
Brazil, Croatia, France, Germany, Greece, Italy, Poland, South Africa, Spain, United Kingdom, United States
Outcome results
None listed