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A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia
- Infectious Diseases
- COVID-19 Pneumonia
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Cities
- Boise
- Cercado de Lima
- Charlotte
- Ciudad de México
- comas
- Culiacán Rosales
- Detroit
- el-agustino
- el-centro
- Farmington
- Fayetteville
- Germantown
- Harlingen
- Hialeah
- Houston
- McAllen
- Miami
- Nairobi
- New Orleans
- New York
- Oakland
- Orange
- paterson
- Philadelphia
- Phoenix
- Potsdam
- San Diego
- San Juan de Miraflores
- San Leandro
- Silver Spring
- South Miami
- St. George
- São Paulo
- Tucson
- Virginia Beach
Trial Identifier:
NCT04372186 ML42528
Trial 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 pneumonia, and b) include an optional long-term extension for eligible participants to explore the long-term sequelae of resolved COVID-19 pneumonia.
Genentech, Inc.
Sponsor
Phase 3
Phase
NCT04372186,ML42528
Trial Identifier
Placebo, Tocilizumab
Treatments
COVID-19 Pneumonia
Condition
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Patients With COVID-19 Pneumonia
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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
For the latest version of this information please go to www.forpatients.roche.com