跳至主要内容
临床试验/NCT05017441
NCT05017441招募中不适用

TOcilizumab and Covid-19 : Risk of Severe INfection

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2021年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,200
试验地点
1
主要终点
Frequency of infectious episodes during the hospitalization period

研究概览

简要总结

SARS-CoV2 is responsible for a pandemic that has been evolving for approximately 18 months. The virus' capacity for dissemination and its virulence are responsible for significant morbidity and mortality. The initial lack of knowledge of the pathogen and of the pathophysiology underlying the potential severity of the disease, particularly in the respiratory tract, led to numerous therapeutic attempts in this emergency context, centered on the control of an obviously exaggerated inflammatory response. A large number of studies remained of insufficient quality to lead to relevant and applicable conclusions. Secondly, the benefit of corticosteroid therapy has been demonstrated in two trials. Although Dexamethasone remains the only corticosteroid to improve survival, these results have reinforced the hypothesis of the interest of treatments reducing the inflammatory response, particularly cytokine. The widespread use, in the absence of scientific data, of interleukin-6 receptor inhibitors (Sarilumab and Tocilizumab) has been structured around studies whose results remain uncertain to this day because of the heterogeneity of the population treated and the results observed. A possible survival benefit seems to emerge for resuscitation patients who have not yet required invasive ventilation, the other situations being probably associated with the absence of effect or even the potential danger of this treatment. Tocilizumab is notably associated in the literature with the risk of secondary infections and mucosal healing abnormalities, favoring bleeding complications and digestive perforations. The objective of this study is to evaluate the risk of digestive complications (hemorrhage, perforation, diverticulitis) and infectious complications related to the use of Tocilizumab according to the severity of the patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient whose age ≥ 18 years
  • French-speaking patient
  • Patient with COVID-19 documented by PCR test or chest CT scan

排除标准

  • No confirmation of suspected COVID-19
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his/her data for this research

结局指标

主要结局

Frequency of infectious episodes during the hospitalization period

时间窗: Day 90

This outcome corresponds to occurrence of an infectious episode during hospitalization in a ward and/or intensive care unit.

次要结局

  • Digestive complication rate(Day 90)
  • Death rates(Day 28)
  • Rate of hematological complications(Day 90)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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TOcilizumab and Covid-19 : Risk of Severe INfection | 临床试验