Lead Sponsor

Hoffmann-La Roche

Age

0 - 17 years

Sex

ALL

Healthy Volunteers

No

•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

•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)

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