JPRN-jRCT2080225174已完成3 期
A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia in Japan
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 49
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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