A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia
Condition: COVID-19 Pneumonia
MeSH terms: COVID-19; Pneumonia
Intervention: Placebo; Tocilizumab
Intervention description: Participants will receive one dose of IV placebo matched to TCZ. Up to one additional dose may be given.; Participants will receive one IV infusion of TCZ 8 mg/kg, with a maximum dose of 800 mg. Up to one additional dose may be given.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 377.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study (EMPACTA) will a) evaluate the efficacy and safety of tocilizumab (TCZ) compared
      with a placebo in combination with standard of care (SOC) in hospitalized participants with
      COVID-19 pneumonia, and b) include an optional long-term extension for eligible participants
      to explore the long-term sequelae of resolved COVID-19 pneumonia.
    

Eligibility criteria:

        Inclusion Criteria

          -  Hospitalized

          -  COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any
             specimen and radiographic imaging

          -  SpO2 < 94% while on ambient air

        Inclusion Criteria Specific to Long-Term Extension

          -  Participated in Study ML42528 (EMPACTA) (includes participants who completed or
             discontinued early from the main study)

        Exclusion Criteria

          -  Known severe allergic reactions to TCZ or other monoclonal antibodies

          -  Require continuous positive airway pressure (CPAP), bilevel positive airway pressure
             (BIPAP), or invasive mechanical ventilation

          -  Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)

          -  In the opinion of the investigator, progression to death is imminent and inevitable
             within the next 24 hours, irrespective of the provision of treatments

          -  Immunocompromised (besides well-controlled HIV) or on immunosuppressive therapy
             (except for steroids for COVID), advanced cancer

          -  Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the
             past 3 months

          -  Participating in another interleukin (IL)-6 antagonist clinical trial or other drug
             clinical trials (participation in COVID-19 anti-viral trials may be permitted if
             approved by Medical Monitor)

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit
             of normal (ULN) detected within 24 hours at screening (according to local laboratory
             reference ranges)

          -  Absolute neutrophil count (ANC) < 1000/uL at screening (according to local laboratory
             reference ranges)

          -  Platelet count < 50,000/uL at screening (according to local laboratory reference
             ranges)

          -  Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination

          -  Treatment with an investigational drug within 5 half lives or 30 days (whichever is
             longer) of randomization (investigational COVID-19 antivirals may be permitted if
             approved by Medical Monitor)

          -  Any serious medical condition or abnormality of clinical laboratory tests that, in the
             investigator's judgment, precludes the patient's safe participation in and completion
             of the study

          -  Any history of Diverticulitis or GI perforation

          -  Use of systemic corticosteroids unless on a stable chronic dose