Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia
Lead Sponsor:
Genentech, Inc.
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 pneumon...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2020
Estimated Enrollment :
377 Patients enrolled
Trial Details
Trial ID
NCT04372186
Start Date
May 14 2020
End Date
September 22 2020
Last Update
February 10 2023
Active Locations (44)
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1
Banner - University Medical Center Phoenix; In-Patient Pharmacy
Phoenix, Arizona, United States, 85006
2
Univ of AZ Coll of Med
Tucson, Arizona, United States, 85724
3
El Centro Regional Medical Center
El Centro, California, United States, 92243
4
eStudySite
La Mesa, California, United States, 91942