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临床试验/NCT05367882
NCT05367882已完成不适用

Effects of Sarilumab on Interleukin 6 Levels in Critically Ill COVID-19 Patients

Assiut University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
1
主要终点
interleukin-6 levels

研究概览

简要总结

  1. Investigate the possible effects of interleukin-6 receptor antagonists such as tocilizumab and sarilumab on the levels of IL-6, inflammtory and anti-inflammtory markers and cytokines before and after treatment in critically ill corona virus disease-19 patients.
  2. Correlate between IL-6 levels with other inflammatory markers as ferritin and C-reactive protein.
  3. investigate the possible changes on the levels of other inflammatory, anti-inflammatory markers and cytokines such as IL-10 and IP-10, before and after treatment.

详细描述

An outbreak of a mutated respiratory virus that belongs to the Coronavirus family was reported in mid-December 2019, in Wuhan, China. The virus was named as severe acute respiratory syndrome coronavirus (SARS-CoV-2) and the disease was named as coronavirus disease-19 (COVID-19) by the WHO. The infection spread pandemically and by the end of October 2021,the number of confirmed cases of COVID-19 reached 244,897,472, including 4,970,435 deaths, reported by WHO. Viral genome was sequenced and published by public health information on 10th of January. COVID-19 uses the same cell entry receptor {Angiotensin converting enzyme II} (ACE2) as SARS-CoV . Recent studies have shown that IL-6 level increased in severe cases of COVID-19. IL-6 is one of the major pro-inflammatory factors that contribute to the formation of cytokine storm.Therefore, the IL-6 monoclonal antibody (mAb) directed COVID-19 therapy has been used in clinical trial in China. The main conclusion they reached was that the treatment with the IL-6 receptor antagonists ( tocilizumab (TCZ), sarilumab, sirukumab, olamkicept and levilimab) improved outcomes, including survival. TCZ is a humanized antibody that blocks both soluble and membrane-bound forms of IL-6 receptor. Sarilumab is a fully human antibody against the IL-6 receptor that binds to both soluble and membrane-bound IL-6 receptors and has the approval of the food and drug administration (FDA) for rheumatoid arthritis (RA) treatment. Additionally, these drugs have been considered for off-label use in the treatment of COVID-19.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • must be critically ill coronavirus disease-19

排除标准

  • patients receiving corticosteroids
  • pregnancy
  • active TB
  • bacterial infection
  • fungal infection
  • co-infection with other hepatitis viruses.

结局指标

主要结局

interleukin-6 levels

时间窗: during one year

Measuring the levels of interleukin-6 in serum of patients.

anti-inflammatory markers

时间窗: during one year

measuring the levels of some anti-inflammatory markers in serum of patients before and after treatment

interleukin-10 levels

时间窗: during one year

measuring the levels of interleukin-10 in serum of patients before and after treatment

inflammatory markers

时间窗: during one year

measuring the levels of some inflammatory markers in serum patients

interferon gamma inducible protein-10 levels

时间窗: during one year

measuring the levels of IP-10 in serum of patients before and after treatment

次要结局

  • survival(during one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Reem Mohamed Mohamed Ahmed

Principle investigator

Assiut University

研究点 (1)

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