A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia

  • COVID-19 Pneumonia
Trial Status:

Active, not recruiting

This trial runs in
Countries
  • Brazil
  • Kenya
  • Mexico
  • Peru
  • South Africa
  • United States
Trial Identifier:

NCT04372186 ML42528

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial 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.

      Genentech, Inc. Sponsor
      Phase 3 Phase
      NCT04372186 , ML42528 Trial Identifier
      Placebo, Tocilizumab Treatments
      COVID-19 Pneumonia Condition
      Official Title

      A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Patients With COVID-19 Pneumonia

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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

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