A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia in Japa
- Conditions
- COVID-19 pneumonia
- Registration Number
- JPRN-jRCT2080225174
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
For the efficacy results, see primary outcome measures section. Regarding the pharmacokinetics, there were no major differences in serum tocilizumab concentrations or pharmacokinetic parameters obtained in this study compared with patient with rheumatoid arthritis. Regarding the safety, based on the AEs observed in this study, there were no safety signals that differed from the safety profile identified in drug so far, and the safety was considered acceptable for patients with severe COVID-19 pneumonia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 49
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Safety : Incidence and severity of adverse events, change from baseline in clinical laboratory test results<br>Efficacy : 7 category ordinal scale
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>pharmacodynamics<br>Efficacy : Time to clinical improvement<br>PK : TCZ PK profile<br>PD : Serum concentrations of IL-6, sIL-6R, and CRP