NCT04351919撤回4 期
Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+), inTunisia
Abderrahmane Mami Hospital1 个研究点 分布在 1 个国家开始时间: 2020年5月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Evolution of clinical signs
研究概览
简要总结
The study will assess the number of patients who become asymptomatic from clinical signs of COVID19 and will assess the efficacy of Hydroxychloroquine (HCQ) and Azithromycine effects on paucisymptomatic patients with ou without co-morbidities
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed COVID19 (+)
- •Qt<500ms
- •no severity criteria
- •pauci-symptomatique patients
- •signed consent form
排除标准
- •no confirmed patient COVID19
- •severity criteria
- •known allegies to macrolides and HCQ
- •Treated with HCQ within 1 month prior to inclusion
- •hepatitis insufficiency
- •Renal insufficiency
- •treatment no indicated with azithro and HCQ
- •hypovolemia
- •complete brach block
- •retinopathia
- •psoriasis
- •pregnancy or breastfeeding
研究组 & 干预措施
HCQ Arm
Experimental
干预措施: Hydroxychloroquine (Drug)
HCQ Arm
Experimental
干预措施: Azithromycin (Drug)
结局指标
主要结局
Evolution of clinical signs
时间窗: at the end of the study treatment - 1 month after inclusion
Low respiratory signs with severity criteria
improvment or healing of clinical signs
时间窗: at the end of the study treatment - 1 month after inclusion
no respiratory infectious signs
次要结局
未报告次要终点
研究者
Dr Jalila Ben Khelil
Head of department
Abderrahmane Mami Hospital
研究点 (1)
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