NCT04455243Unknown3 期
Pilot Double Blinded Randomized Placebo Controlled Multi Central Clinical Trial on Inflammatory Regulation Effect of NAC on COVID-19
Dr. Tariq Alhawassi0 个研究点目标入组 1,180 人开始时间: 2020年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,180
- 主要终点
- Time to Recovery
研究概览
简要总结
Study times to evaluate the efficacy of N-Acetylcysteine therapy in the management of adult admitted patients with COVID-19.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 above 18 years of age
- •Admitted to the hospital With confirmed COVID-19 by RT-PCR test
- •On oxygen supplement
排除标准
- •Active use of NAC
- •Known NAC allergy
- •In the opinion of the treating team, progression of death is imminent and inevitable within the next 24 hour, irrespective of provision treatment
- •All patients enrolled in any other investigational drug studies in COVID-19.
研究组 & 干预措施
Intervention group
Experimental
干预措施: N-Acetyl cysteine (Drug)
Control group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Recovery
时间窗: 28 days
Day of recovery is defined as the first day on which of the following three categories from The Ordinal Scale on Covid-19 Clinical Improvement 1. Not-Hospitalized, No limitation on activity. 2. Not Hospitalized, with limitation on activity. 3. Hospitalized, Not requiring supplemental Oxygen
次要结局
未报告次要终点
研究者
Dr. Tariq Alhawassi
Chairman of Clinical Trial Support Unit
King Saud University
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