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

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-rayor CT scan
• Receiving systemic corticosteroids at baseline
• Oxygen saturation < 93% on room air, or requiring supplemental oxygen, non-invasive orinvasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) tomaintain 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 inevitablewithin the next 48 hours, irrespective of the provision of treatments
• Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within thepast 3 months prior to enrollment
• Treatment with an investigational drug within 5 drug-elimination half-lives or 30days, whichever is longer, of enrollment (except for anti-SARS-CoV-2 antibodies ordirectly-acting antivirals)
• Participating in another interventional drug clinical trial (except foranti-SARS-CoV-2 antibodies or directly-acting antivirals)