NCT04321616Unknown2 期
The (Norwegian) NOR Solidarity Multicenter Trial on the Efficacy of Different Anti-viral Drugs in SARS-CoV-2 Infected Patients
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2020年3月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- In-hospital mortality
研究概览
简要总结
The (World Health Organization) WHO NOR- (Coronavirus infectious disease) COVID 19 study is a multi-centre, adaptive, randomized, open clinical trial to evaluate the safety and efficacy of hydroxychloroquine, remdesivir and standard of care in hospitalized adult patients diagnosed with COVID-19. This trial will follow the core WHO protocol but has additional efficacy, safety and explorative endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, 18 years and above
- •Confirmed SARS-2-CoV-2 infection by PCR
- •Admitted to the hospital ward or the ICU
- •Subjects (or legally authorized representative) provides written informed consent prior to initiation of the study
排除标准
- •Severe co-morbidity with life expectancy <3 months according to investigators assessment
- •(Aspartate Transaminase/ Alanine Aminotransferase) ASAT/ALAT > 5 times the upper limit of normal
- •Acute co-morbidity within 7 days before inclusion such as myocardial infarction
- •Known intolerance to the available study drugs
- •Pregnancy, possible pregnancy or breast feeding
- •Any reason why, in the opinion of the investigators, the patient should not participate
- •Subject participates in a potentially confounding drug or device trial during the course of the study
- •Prolonged QT interval (>450 ms)
研究组 & 干预措施
Hydroxychloroquine
Active Comparator
干预措施: Remdesivir (Drug)
Hydroxychloroquine
Active Comparator
干预措施: (Standard of Care) SoC (Other)
Remdesivir
Active Comparator
干预措施: Hydroxychloroquine (Drug)
Remdesivir
Active Comparator
干预措施: (Standard of Care) SoC (Other)
Control group - SoC
Active Comparator
干预措施: Hydroxychloroquine (Drug)
Control group - SoC
Active Comparator
干预措施: Remdesivir (Drug)
结局指标
主要结局
In-hospital mortality
时间窗: 3 weeks
All cause in-hospital mortality
次要结局
- Occurrence and duration of intensive care unit (ICU) treatment(3 weeks)
- Duration of hospital admittance(1 month)
- 28 Day mortality(3 weeks)
- Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen(3 weeks)
- Occurrence of co-infections(3 weeks)
- Occurrence of organ dysfunction(3 months)
- Occurrence and duration of mechanical ventilation(3 weeks)
研究者
Andreas Barratt-Due
Principal investigator, MD, PhD
Oslo University Hospital
研究点 (1)
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