Effect of N-acetylcysteine on Oxidative Stress And Occurrence of Complications in Patients With COVID 19 Infections
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in TNF alfa level from baseline
研究概览
简要总结
The purpose of the study is to assess the potential therapeutic effect of N-acetylcysteine "NAC" in COVID 19 patients.
详细描述
This is a phase 3 trial enrolling subjects with newly diagnosed Corona virus disease 2019 ( COVID-19) infection who are classified as moderate cases and require hospitalization. Patients meeting eligibility criteria will be randomized either to receive oral N-acetylcysteine or not along with the institution treatment protocol . Treatment efficacy will be assessed using certain endpoints as follows:
- Markers of inflammation and oxidative stress
- Length of hospital stay
- Need for ventilation
- Mortality rate
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
- Double (Participant, Care Provider)
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
- •Adults aged more than 18 years
- •Documented COVID-19 infection (either performed on site or documented external report), only moderate cases will be included
排除标准
- •Known allergy or hypersensitivity to NAC
- •Critically ill or mechanically ventilated patients
研究组 & 干预措施
N-acetylcysteine (NAC)
Patients receiving N-acetylcysteine (NAC)
干预措施: N-acetylcysteine (Drug)
结局指标
主要结局
Change in TNF alfa level from baseline
时间窗: from enrollment till the end of treatment at 2 weeks or until hospital discharge or death
The mean change in TNF alfa is used to assess NAC efficacy
次要结局
- Length of hospital stay(Through study completion ( average 9 months))
- Need for mechanical ventilation(Through study completion ( average 9 months))
- Change in IL-6 level from baseline(from enrollment till the end of treatment at 2 weeks or until hospital discharge or death)
- Change in glutathione peroxidase level from baseline(from enrollment till the end of treatment at 2 weeks or until hospital discharge or death)
研究者
Sara Mohamed Sherkawy
Principal Investigator at the Faculty of pharmacy
Ain Shams University