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
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.