EUCTR2020-001995-13-ES进行中（未招募）1 期
A multicentre, open-label clinical trial to evaluate the effectiveness and safety of intravenous tocilizumab for treating patients with COVID-19 pneumonia: the BREATH-19 Study
Fundación SEIMC-GESIDA0 个研究点目标入组 500 人开始时间: 2020年5月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Provide oral informed consent to participate in this study.
- •- At least 18 years of age.
- •- Diagnosed with COVID-19 pneumonia by RT-PCR.
- •- Have received the first dose of tocilizumab a maximum of two days before the inclusion or is candidate for tocilizumab treatment.
- •- Hospitalized or admitted to ICU.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
排除标准
- •- The patient has any other medical condition or is receiving concomitant medication that could, in the opinion of the investigator, compromise the patient’s safety or collected data.
- •- Known severe allergic reactions to tocilizumab or other monoclonal antibodies.
- •- Active acute and severe infections, including tuberculosis infection.
- •- Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
研究者
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