Education and Training
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 =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)
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