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临床试验/ACTRN12620000580976
ACTRN12620000580976撤回1 期

Tocilizumab for the treatment of COVID-19 in intensive care patients: effect on days free of ventilatory support.

QIMR Berghofer Medical Research Institute0 个研究点目标入组 150 人开始时间: 2020年5月19日最近更新:

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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