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
Arm | Description | Assigned 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. |
|
Experimental Tocilizumab |
Participants will receive one IV infusion of TCZ in addition to SOC. Up to one additional infusion may be given. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04372186
- Status
- Completed
- Sponsor
- Genentech, Inc.