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临床试验/IRCT20120703010178N20
IRCT20120703010178N20尚未招募3 期

?Evaluation of Safety and efficacy of anakinra utilization in COVID-19, a randomized controlled clinical trial

Persisgen Par Pharmaceutical Company0 个研究点目标入组 30 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30

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
18 years 至 no limit(—)
性别
All

入选标准

  • Age of 18 years or more
  • Elevated C-reactive protein levels
  • Fever or cough or dyspnea
  • SpO2 of 93% or less
  • Confirmed SARS-CoV-2 infection by rt-PCR or radiology
  • PaO2/FiO2 of 300 or less
  • Ability to understand and desire to sign a form of informed consent to participate in the study

排除标准

  • Positive PPD test
  • Active Hepatitis B or C infection, Positive HBV antigen or HCV antigen or HIV infection
  • Thrombocytopenia ( platelet count of 150000 per micL)
  • Leukopenia ( white blood cells of 3.6*10^9)
  • Anemia (hemoglobin of 7.5 g/dL)
  • Elevated liver transaminases of 2 fold or more
  • Active infection based on cultures (not received intravenous antibiotics in previous 8 weeks or oral antibiotics in previous 2 weeks)
  • history of malignancy in previous 5 years based on pathology and radiological data
  • history of anakinra, canakinumab or any interleukin-1 inhibitors administration
  • History of receiving of attenuated vaccine in last 2 weeks or during the study
  • hypersensitivity to any component of the medication

研究者

发起方
Persisgen Par Pharmaceutical Company

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