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

NCT04320615

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: COVID-19 Pneumonia

Interventions: Tocilizumab (TCZ), Placebo

Countries: United States, Canada, Denmark, France, Germany, Italy, Netherlands, Spain

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
* SPO2 \</=93% or PaO2/FiO2 \<300 mmHg

Exclusion Criteria:

* Known severe allergic reactions to TCZ or other monoclonal antibodies
* Active tuberculosis (TB) infection
* 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
* Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the past 3 months
* Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
* 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 Medial 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
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 10 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab)
* Absolute neutrophil count (ANC) \< 1000/mL at screening (per local lab)
* Platelet count \< 50,000/mL at screening (per local lab)
Locations (62)
  • La Jolla, California, United States
  • La Mesa, California, United States
  • Los Angeles, California, United States
  • Stanford, California, United States
  • Denver, Colorado, United States
  • Miami, Florida, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Baton Rouge, Louisiana, United States
  • Springfield, Massachusetts, United States
  • Rochester, Minnesota, United States
  • Hackensack, New Jersey, United States
  • New Brunswick, New Jersey, United States
  • The Bronx, New York, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • St. George, Utah, United States
  • Kirkland, Washington, United States
  • Seattle, Washington, United States
  • Hamilton, Ontario, Canada
  • Hamilton, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Copenhagen, Denmark
  • Hvidovre, Denmark
  • Odense C, Denmark
  • + 32 more on CT.gov