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临床试验/CTRI/2020/05/025369
CTRI/2020/05/025369已完成3 期

A Multi-center, Randomized Controlled, Phase III Study to evaluate the Clinical Outcomes and Safety of Tocilizumab along withStandard of Care in Patients with Cytokine Release Syndrome associated with COVID-19 infection - COVINTOC

Medanta Institute of Education and Research MIER0 个研究点目标入组 180 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
已完成
发起方
入组人数
180
研究概览入排标准研究者记录与标识符相似试验

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

入选标准

  • •I. Male or female subjects who are >=18 years of age, on the day of signing informed consent.
  • •II. Patient or Legally Acceptable Representative (LAR) willing to give informed Consent before study procedure.
  • •III. Hospitalized with COVID-19 infection confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid).
  • •IV. Moderate to severe COVID 19 infection (moderate disease â?? increased respiratory rate 15 to 30/minute and SpO2 90%-94%; and severe disease - respiratory rate >= 30/minute and/or SpO2 < 90% on room air, or ARDS or Septic shock

排除标准

  • •I. Known severe allergic reactions to TCZ or other monoclonal antibodies
  • •II. Active tuberculosis (TB) infection.
  • •III. Suspected or active bacterial, fungal, viral (except treated HCV or HBV infection), or other infection (besides COVID-19).
  • •IV. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
  • •V. Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with in the past 6 months.
  • •VI. Participating in other drug clinical trials
  • •VII. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
  • •VIII. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
  • •IX. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the patient safe participation in and completion of the study.
  • •X. Definite diagnosis of rheumatic immune related diseases.
  • •XI. Administration of steroids equivalent to methylprednisolone at a dose >1mg/kg/day) at screening/baseline
  • •XII. Absolute Neutrophil count <500, platelet count <50,000 per microliter at screening/baseline
  • •XIII. Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) >10 times upper limit of normal detected with-in 24 hours at screening/baseline

研究者

发起方
Medanta Institute of Education and Research MIER

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