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

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19 Pneumonia

In brief

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.

Key facts

Study ID

NCT04372186

Run by

Genentech, Inc.

People needed

377

Starts

2020-05-14

Expected to finish

2020-09-22

Last updated by the study team

2023-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Banner - University Medical Center Phoenix; In-Patient Pharmacy — Phoenix, Arizona, United States
• Univ of AZ Coll of Med — Tucson, Arizona, United States
• El Centro Regional Medical Center — El Centro, California, United States
• eStudySite — La Mesa, California, United States
• Highland Hospital Oakland — Oakland, California, United States
• St. Joseph'S Hospital — Orange, California, United States
• San Leandro Hospital; Inpatient Pharmacy — San Leandro, California, United States
• Larkin Community Hospital Palm Springs Campus (Hialeah) — Hialeah, Florida, United States
• Miami Veterans Administration Healthcare System - NAVREF — Miami, Florida, United States
• University of Miami Pulmonary — Miami, Florida, United States
• Larkin Community Hospital — South Miami, Florida, United States
• St. Lukes Boise Medical Center — Boise, Idaho, United States
• Ochsner Clinic — New Orleans, Louisiana, United States
• Holy Cross Germantown Hospital — Germantown, Maryland, United States
• Holy Cross Hospital — Silver Spring, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• St. Joseph'S Regional Medical Center — Paterson, New Jersey, United States
• San Juan Oncology Associates — Farmington, New Mexico, United States
• SUNY Downstate Medical Center. — Brooklyn, New York, United States
• Elmhurst Hospital Center — Elmhurst, New York, United States
• Flushing Hospital — Flushing, New York, United States
• Jamaica Hospital Medical Center — Jamaica, New York, United States
• Harlem Hospital — New York, New York, United States
• Canton-Potsdam Hospital — Potsdam, New York, United States
• St. Barnabas Hospital — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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