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临床试验/NCT05035589
NCT05035589已完成不适用

The Effect of Tocilizumab on Procalcitonin and Other Biochemical and Clinical Markers in the Setting of COVID-19 Pneumonia

Sciberras, Stephen M.D.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年9月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Procalcitonin

研究概览

简要总结

This study aims to establish whether tocilizumab has any significant effect on procalcitonin levels on patients diagnosed with COVID-19 pneumonia requiring intensive care admission. The effects on other biochemical and clinical markers are also considered.

详细描述

A retrospective study, involving the first fifty patients treated with tocilizumab for acute deterioration in COVID-19 pneumonia in the Intensive Care Unit (ICU) at Mater Dei Hospital in Malta.

The following parameters will be collected from medical records:

  • procalcitonin levels, daily for twenty days or until discharge or death.
  • namely white cell count (WCC), neutrophils, lymphocytes,
  • C-reactive protein (CRP)
  • PaO2/FiO2 ratio (P/F ratio).

This group will be compared to a control group was chosen from patients admitted to the ICU who were not eligible for tocilizumab treatment, matched to the study group for age, gender, mode of ventilation required and length of stay in ICU.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed COVID-19 diagnosis
  • Admitted to ITU
  • Tocilizumab treatment

排除标准

  • 未提供

研究组 & 干预措施

TCZ

The first 50 patients admitted to the ITU at Mater Dei Hospital with COVID-19 Pneumonia, to whom tocilizumab was administered

干预措施: Tocilizumab (Drug)

结局指标

主要结局

Procalcitonin

时间窗: throughout study completion, daily for maximum of 20 days

effect of Tocilizumab on Procalcitonin levels

次要结局

  • P/F ratio(throughout study completion, daily for maximum of 20 days)
  • CRP(throughout study completion, daily for maximum of 20 days)
  • WCC(throughout study completion, daily for maximum of 20 days)
  • NLR(throughout study completion, daily for maximum of 20 days)
  • Neutrophils(throughout study completion, daily for maximum of 20 days)
  • Lymphocytes(throughout study completion, daily for maximum of 20 days)

研究者

发起方
Sciberras, Stephen M.D.
申办方类型
Indiv
责任方
Principal Investigator
主要研究者

Stephen Sciberras

Investigator

Sciberras, Stephen M.D.

研究点 (1)

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