A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease (COVID)-19

Inclusion Criteria:

- Hospitalized

- Has laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
infection as determined by real time-polymerase chain reaction (PCR) at any time
before randomization

- Evidence of infiltrates by chest X-ray, chest computed tomography (CT), lung
ultrasound, or chest auscultation (rales, crackles)

- Informed consent must be obtained from the participant indicating that he or she
understands the purpose of, and procedures required for, the study and is willing to
participate in the study

- Critical COVID-19 disease, defined as: Requires supplemental oxygen delivered by
nonrebreather mask or high-flow nasal cannula or use of non-invasive or invasive
ventilation or requiring treatment in an intensive care unit

1. AND corresponding to category 4 on the 6-point ordinal recovery scale, that is:
requires one of the above modalities to sustain a peripheral capillary oxygen
saturation (SpO2) greater than (>) 93 percent (%) with a fraction of inspired
oxygen (FiO2) of 50% or higher. Note, the use of other devices may fit with
category 4 if the FiO2 is 50% or higher.

2. OR, corresponding to category 5 on the 6-point ordinal recovery scale, that is
partial pressure of oxygen in arterial per percentage of inspired oxygen
(PaO2/FiO2) ratio < 300 millimeter of mercury (mmHg) while on invasive mechanical
ventilation or veno-venous extracorporeal membrane oxygenation (ECMO) for less
than 48 hours prior to screening

Exclusion Criteria:

- On invasive mechanical ventilation or on veno-venous ECMO for >48 hours at time of
screening

- Received an investigational intervention (including investigational vaccines) or used
an invasive investigational medical device within 30 days before the planned dose of
study intervention. Note: the investigator must ensure that the participant is not
enrolled in another COVID-19 study with an investigational intervention (apart from
the exception specified below) prior to completion of Day 28 of the current study.
Exception: participation in a single arm study, a non-blinded controlled study,
expanded access, compassionate use program or any other program that is not a blinded
study is allowed if it is conducted with one of the following: agents with
demonstrated in vitro-effect against SARSCoV- 2, as mentioned in the center of disease
control and prevention (CDC) guidelines and convalescent plasma

- Current confirmed or high suspicion for pulmonary embolus, hemodynamic significant
pericardial effusion, myocarditis, or Class 3 or 4 congestive heart failure as defined
by the New York Heart Association Functional Classification AND/OR Current evidence of
active cardiac ischemia

- Has a history of respiratory condition (that is, asthma, chronic obstructive pulmonary
disease (COPD), cystic fibrosis, fibrotic lung disease) that requires home oxygen
supplementation, supportive non-invasive ventilation or, is status/post lung volume
reduction surgery (LVRS). Exception: Participants with sleep apnea using supportive
non-invasive ventilation (continuous positive airway pressure [CPAP]) at screening may
be included

- On renal replacement therapy (defined as peritoneal dialysis or hemodialysis)

- Screening laboratory test result as follows: absolute neutrophil count (ANC) <1.0*10^3
cells/microliter; Platelet count <50*10^3 cells/microliter; estimated glomerular
filtration rate (eGFR) <=30 milliliter per minute per 1.73 square meter (mL/min/1.73
m^2); Bilirubin >2* upper limit of normal (ULN) unless bilirubin rise is due to
Gilbert's syndrome or of non-hepatic origin; alanine aminotransferase/ aspartate
aminotransferase (ALT) >5*ULN; Prothrombin time (PT)/international normalized ratio
(INR) >1.5*ULN or activated partial thromboplastin time (aPTT) >1.5*ULN related to
known coagulopathy or bleeding disorder (the participant can receive anticoagulant
therapies for underlying conditions, or as systematic thromboprophylaxis due to
COVID-19, or as part of the treatment of complications of COVID-19, but cannot
participate in a clinical study with anticoagulants for COVID-19)

- Pregnant or breastfeeding, unless in the opinion of the investigator, the benefit
outweighs the risks

- Has active hepatitis B or C infection or has human immunodeficiency virus infection or
acquired immune deficiency syndrome (HIV/AIDS) based on medical history and/or
concomitant medication

- Known active or latent tuberculosis (TB), history of incompletely treated TB,
suspected or known extrapulmonary TB based on medical history and/or concomitant
medication

- Evidence of active bacterial (including but not limited to bacterial pneumonia),
fungal, viral or opportunistic infection (other than SARS-CoV-2)

- Currently active clinically significant (example, causing hemodynamic instability
and/or causing hypoxemia) and uncontrolled arrhythmia