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.
Drug: Placebo
Participants will receive one dose of IV placebo matched to TCZ. Up to one additional dose 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.
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
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
St. Barnabas Hospital
Bronx, New York, 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
Novant Health Presbyterian Medical Center (Presbyterian Hospital)
Charlotte, North Carolina, United States
Cape Fear Valley Medical Center
Fayetteville, North Carolina, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Valley Baptist Medical Center
Harlingen, Texas, United States
Michael E Debakey VA Medical Center
Houston, Texas, United States
McAllen Medical Center
McAllen, Texas, United States
Sentara Medical Group
Virginia Beach, Virginia, United States
Hospital E Maternidade Celso Pierro PUCCAMP
Campinas, SP, Brazil
Centro Multidisciplinar de Estudos Clínicos CEMEC FMABC
Sao Bernardo Do Campo, SP, Brazil
BR Trials - Pesquisa Clínica
Sao Paulo, SP, Brazil
Aga Khan University Hospital
Nairobi, Kenya
Hospital General de Culiacan
Culiacan, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico, Mexico
Hospital Militar Central
Jesus Maria, Peru
Hospital Nacional Sergio E. Bernales
Lima, Peru
Hospital Nacional Cayetano Heredia
Lima, Peru
Hospital Nacional Hipolito; Unanue
Lima, Peru
Hospital Maria Auxiliadora
Lima, Peru
George Provincial Hospital
George, South Africa
Clinical Trials, Study Director
Hoffmann-La Roche