A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia

Inclusion Criteria

- Hospitalization with COVID-19 pneumonia confirmed by a positive polymerase chain
reaction (PCR) of any specimen [e.g., respiratory, blood, urine, stool, and other
bodily fluids]) and evidence of pneumonia on chest X-ray or computed tomography scan

- For severe patients, SpO2 supplemental oxygen with SpO2 > 93%, but desaturation oxygen or ambient air is documented during screening, the inclusion criterion is met

- For moderate patients (those who do not qualify as severe based oxygen requirements),
CRP > 2 x upper limit of normal (ULN) is required

- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraception, as defined by the protocol

- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
a condom, and agreement to refrain from donating sperm, as defined by the protocol

Exclusion Criteria

- Known severe allergic reactions to TCZ or other monoclonal antibodies

- Active tuberculosis (TB) infection

- Suspected active bacterial, fungal, viral, or other infection (besides SARS-CoV-2)

- Participants who are on a mechanical ventilator > 24 hours or extracorporeal membrane
oxygenation (ECMO), in shock, or combination thereof with other organ failure
requiring treatment in an ICU

- In the opinion of the investigator, progression to death is imminent and inevitable
within the next 24 hours, irrespective of the provision of treatments

- Receipt of oral anti-rejection or immunomodulatory drugs (including TCZ) within the
past 3 months

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x ULN detected
within 24 hours at screening or at baseline (according to local laboratory reference
ranges)

- Absolute neutrophil count (ANC) < 1000/uL at screening and baseline (according to
local laboratory reference ranges)

- Platelet count < 50,000/uL at screening and baseline (according to local laboratory
reference ranges)

- Pregnancy or breastfeeding, or positive pregnancy test at a predose examination

- Treatment with an investigational drug within 5 drug-elimination half-lives or 30 days
(whichever is longer) of randomization