COVID19 Pneumonia
Conditions
Interventions
Tocilizumab
Placebo
Sponsors
Genentech Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measures : Cumulative Proportion of Participants Requiring Mechanical Ventilation by Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Measures : Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status [ Time Frame: Up to Day 28 ] Time to Clinical Failure, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal (whichever occurs first) [ Time Frame: Up to Day 28 ] Mortality Rate by Day 28 [ Time Frame: Up to Day 28 ] Time to Hospital Discharge or "Ready for Discharge" (as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or >/= 2 liters (L) supplemental oxygen) [ Time Frame: Up to Day 28 ] Percentage of Participants with Adverse Events [ Time Frame: Up to Day 60 ] Percentage of Participants with any Post-Treatment Bacterial and/or Fungal Infection [ Time Frame: Up to Day 60 ] Incidence of Post-Treatment Acute Kidney injury (defined by 50% increase of creatinine from baseline) [ Time Frame: Up to Day 60 ] | — |
Countries
Brazil, Kenya, Mexico, Peru, South Africa, United States of America
Contacts
Public ContactHuwaida Bulhan
Clinical Operations Lead SubSahara Africa
Outcome results
None listed