A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease (COVID)-19
Condition: Critical Confirmed Coronavirus Disease (COVID)-19
MeSH terms: Coronavirus Infections
Intervention: Sirukumab; Placebo; Standard of Care (SOC)
Intervention description: Participants will receive single dose infusion of sirukumab on Day 1.; Participants will receive placebo IV single dose infusion on Day 1.; SOC treatment will be determined by the investigator based on local practice and consists of supportive care.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 212.0
Sex: All
Minimum age: 18 Years
Maximum age: 84 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the clinical response of sirukumab (administered as
      a single intravenous dose) plus standard of care (SOC) compared to placebo plus SOC in
      COVID-19.
    

Eligibility criteria:

        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