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

Purpose

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.

Condition

  • COVID-19 Pneumonia

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Participants will receive one intravenous (IV) infusion of placebo, in addition to SOC. Up to one additional infusion may be given.
  • Drug: Placebo
    Participants will receive one dose of IV placebo matched to TCZ. Up to one additional dose may be given.
Experimental
Tocilizumab 		Participants will receive one IV infusion of TCZ in addition to SOC. Up to one additional infusion may be given.
  • Drug: Tocilizumab
    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.

Recruiting Locations

More Details

NCT ID
NCT04372186
Status
Completed
Sponsor
Genentech, Inc.