PACTR202106466447805Other3 期
A Randomized Double-blind Placebo-controlled Study to Evaluate the efficacy and Safety of Tocilizumab in Hospitalized Patients with COVID-19 Pneumonia
适应症
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 379
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria
- •Hospitalized
- •COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen and radiographic imaging
- •SpO2 < 94% while on ambient air
排除标准
- •Exclusion Criteria
- •Known severe allergic reactions to TCZ or other monoclonal antibodies
- •Require continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or invasive mechanical ventilation
- •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
- •Immunocompromised (besides well-controlled HIV) or on immunosuppressive therapy (except for steroids for COVID), advanced cancer
- •Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months
- •Participating in another interleukin (IL)-6 antagonist clinical trial or other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit of normal (ULN) detected within 24 hours at screening (according to local laboratory reference ranges)
- •Absolute neutrophil count (ANC) < 1000/uL at screening (according to local laboratory reference ranges)
- •Platelet count < 50,000/uL at screening (according to local laboratory reference ranges)
- •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 Medical 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
- •Any history of Diverticulitis or GI perforation
- •Use of systemic corticosteroids unless on a stable chronic dose
研究者
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