Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
