EUCTR2020-002458-25-IT进行中（未招募）1 期
Randomized, controlled, open label, phase 2 clinical trial of Interferon-ß-1a (IFNß-1a) in COVID-19 patients. - Clinical study for the treatment with Interferon-ß-1a (IFNß-1a) of COVID-19 patients
OSPEDALE SAN RAFFAELE0 个研究点目标入组 126 人开始时间: 2020年8月10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
- 126
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
- •a.Informed consent signed
- •b.Patients hospitalized with confirmed swab RT-PCR detection of SARS-CoV-2
- •c.X-ray and/or TC diagnosed pneumonia
- •d.Age >=18 years
- •e.Clinical status defined as 3, 4 or 5 on the 7-point ordinal scale
- •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 63
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 63
排除标准
- •a.Known allergy or hypersensitivity to IFNß-1a or IFNß-1b
- •b.Presence of severe concomitant illnesses/medical conditions that in the physician opinion do not allow participation to the stud
- •c.Pregnant or lactating females
- •d.History of major depression disorder or suicidal attempt or suicidal ideation
- •e.Spontaneous blood ALT/AST levels > 5 times the upper limit of normal
- •f.Clinical status defined as 1, 2, or 6 on the 7-point ordinal scale
研究者
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