COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04372186

Clinical Trials Hoffmann-La Roche

global-roche-genentech-trials@gene.com

2020-05-01

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

None

2

Genentech, Inc.

18

None

Brazil;Kenya;Mexico;Peru;South Africa;United States

Severe disease at enrollment

6: Severe disease at enrollment

377

Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28

None

Phase 3

[{"arm_notes": "", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]