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.

Stanford Investigator(s):

Intervention(s):

  • drug: Tocilizumab (TCZ)
  • drug: Placebo

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

Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.