EUCTR2020-002166-13-ES进行中（未招募）1 期
Randomized, open, multicenter phase II clinical trial, proof of concept, to evaluate efficacy and safety of Icatibant in hospitalized patients with SARS-COV-2 (COVID-19) without assisted ventilation compared with standard care - HUB-MdI-ICAT-COVID-201
Dr. Ramón Lleonart Bellfill / Dr. Xavier Corbella Virós0 个研究点目标入组 120 人开始时间: 2020年7月22日最近更新:
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
- 120
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
- •1-adult patients (18 years or older), both sexes
- •2-Sars-CoV-2 infection confirmed by PCR less than 4 days before randomization
- •3-hospitalized with a diagnosis of SARS-CoV-2 pneumonia
- •4-radiographic evidence of pulmonary infiltrates
- •5-grade 4 or 5 on the ordinal scale for the evaluation of the patient's clinical condition
- •6-pO2/FiO2 <380
- •7-men and women of childbearing age who have heterosexual relations must be
- •agreement to use the safe method(s) of contraception
- •8-obtaining the informed consent of the patient or the legal representative.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1-imminent death (life expectancy less than 72h)
- •2-known hypersensitivity or known adverse reactions to the study drug, or its
- •metabolites or excipients of the formulation
- •3-invasive mechanical ventilation
- •4-participation in any other clinical trial
- •5- ALT or AST > 5 x ULN
- •6-creatinine clearance <50 mL/min using the Cockcroft-Gault formula for
- •participants '18 years old [Cockcroft 1976]
- •7-patients with recent acute coronary syndrome (<1 month)
- •8-patients with a history of stroke
- •9-positive pregnancy test
- •10-pregnant or lactating woman
研究者
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