COVID-19 pneumonia
Conditions
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age >=18 years at time of signing Informed Consent Form 2) Hospitalized with COVID-19 pneumonia confirmed per a positive PCR of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan 3) SPO2 <= 93% or PaO2/FiO2 < 300 mmHg
Exclusion criteria
Exclusion criteria: 1) Known severe allergic reactions to TCZ or other monoclonal antibodies 2) Active TB infection 3) Suspected active bacterial, fungal, viral, or other infection (besides COVID-19) 4) Active chronic HBV or HCV 5) Have received live vaccine or live attenuated vaccine within 4 weeks before screening 6) In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments 7) Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months 8) ALT or AST > 10 x ULN detected at screening 9) ANC < 1000/microL at screening 10) Platelet count < 50,000/microL at screening 11) Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination 12) Any serious medical condition that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study (Permitted Therapy) All patients will receive standard of care (eg. anti-viral treatment, low-dose steroids, and supportive care) per local practice for the treatment of COVID-19 pneumonia. If steroids are given, the Sponsor recommends a dose of no more than 1 mg/kg methylprednisolone or equivalent for no more than 5 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Safety : Incidence and severity of adverse events, change from baseline in clinical laboratory test results Efficacy : 7 category ordinal scale | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics pharmacodynamics Efficacy : Time to clinical improvement PK : TCZ PK profile PD : Serum concentrations of IL-6, sIL-6R, and CRP | — |
Countries
Japan
Outcome results
None listed