Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Hoffmann-La Roche

Stanford Investigator(s):

Intervention(s):

  • Drug: Tocilizumab (TCZ)
  • Drug: Placebo

Phase:

Phase 3

Eligibility


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
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)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting