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

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19 Pneumonia

In brief

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.

Key facts

Study ID

NCT04320615

Run by

Hoffmann-La Roche

People needed

452

Starts

2020-04-03

Expected to finish

2020-07-28

Last updated by the study team

2021-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• eStudySite — La Mesa, California, United States
• David Geffen School of Medicine UCLA — Los Angeles, California, United States
• Stanford University — Stanford, California, United States
• Denver Health Medical Center — Denver, Colorado, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Ochsner Clinic Foundation — Baton Rouge, Louisiana, United States
• Baystate Health System — Springfield, Massachusetts, United States
• Mayo Clinic - PPDS — Rochester, Minnesota, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Robert Wood Johnson University Hospital/Rutgers — New Brunswick, New Jersey, United States
• James J Peters Veterans Administration Medical Center - NAVREF — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic Foundation; Pulmonary, Allergy & Critical Care Medicine — Cleveland, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Baylor St. Luke's Medical Center — Houston, Texas, United States
• Ben Taub General Hospital - HCHD — Houston, Texas, United States
• Intermountain LDS Hospital — Salt Lake City, Utah, United States
• Intermountain Medical Group — St. George, Utah, United States
• Evergreen Health Infectious Disease — Kirkland, Washington, United States
• Swedish Hospital Medical Center — Seattle, Washington, United States
• Hamilton General Hospital; Pharmacy — Hamilton, Ontario, Canada
• St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada
• University of California San Diego — La Jolla, California, United States

Full record on ClinicalTrials.gov

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