ACTRN12620000580976撤回1 期
Tocilizumab for the treatment of COVID-19 in intensive care patients: effect on days free of ventilatory support.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •1.Male or female aged greater than or equal to 18 years
- •2.Confirmed SARS-CoV-2 by PCR with sample taken within 14 days prior to randomisation
- •3. Requirement for invasive or non-invasive ventilatory support or admission to ICU (or planned commencement of invasive or non-invasive ventilatory support, or planned admission to ICU)
- •4. Enrolled prior to or within 24 hours of ICU admission
排除标准
- •1.Absolute neutrophil count less than 0.5x10e9/Litre, platelets less than 50x10e9/Litre
- •2.Previous TNF alpha antagonist treatment within the last 3 months
- •3.Confirmed bacterial sepsis or untreated bacterial, mycobacterial or fungal infection
- •4.Untreated hepatitis B virus infection
- •5.Recent major surgery within the last 8 weeks
- •6.Organ transplant recipients
- •7.Primary or secondary immunodeficiency
- •8.History of diverticulitis, inflammatory bowel disease, or other symptomatic gastrointestinal condition that might predispose to bowel perforation
- •9.Known cirrhosis or aminotransferases greater than 5 times upper limit of normal
- •10.Pregnant or breastfeeding
- •11.Known allergy or hypersensitivity to TCZ or other monoclonal antibodies
- •12.Previous participation in the trial
- •13.Patient being treated with palliative intent, or not expected to be alive in 48 hours
研究者
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