NCT04528927撤回3 期
Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Acute Respiratory Failure, in Tunisia Multicentric Randomized Comparative Study
Abderrahmane Mami Hospital1 个研究点 分布在 1 个国家开始时间: 2020年5月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Evaluate the rate of patients cured at the end of the study.
研究概览
简要总结
Evaluation of the efficacy and safety of Treatments for Patients Hospitalized for COVID-19 Infection without signs of acute respiratory failure, in Tunisia Multicentric Randomized Comparative Study
详细描述
Arm 1:
- Hydroxychloroquine (HCQ): 600 mg on the 1st day as a starting dose then 200 mg * 2 /D for 9 days
- Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
- Usual standard treatment
Arm 2:
- HCQ: 600 mg on the 1st day as a starting dose then 200 mg * 2 / D for 9 days
- Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
- Zinc: 220 mg per day for 10 days
- Usual standard treatment
Arm 3:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed patient COVID19 positive with clinical signs of acute lower respiratory infection with signs of pneumonia or bronchitis: fever and / or cough and / or difficulty breathing in the absence of acute respiratory failure (PaO2> 60 mmHg) with Plus or less :
- •Asthenia, fatigability
- •Arthromas myalgia
- •Dry throat
- •Rhinorrhea
- •An anosmia
- •chest pain
- •Nausea and vomiting
- •Absence of rhythm disturbance (Qt interval <500ms)
- •Patients hospitalized in the medical service
- •18 years old <Age <80 years old
- •Having given written consent for their participation in the study
排除标准
- •Allergy to macrolides, local anesthetics such as lidocaine or amide type and betalactamines
- •Take hydroxychloquine in the previous month
- •Severe / severe liver failure
- •Kidney failure (GFR <30 ml / min / 1.73 m2)
- •Ongoing treatments with colchicine, ergot, rye, pimozide, mizolastine, simvastatin, lomitapide, alfuzosin, dapoxetine, avanafil, ivabradine, eplerenone, dronedarone, quetiapine, ticagrelor, cisapride, astemizole, terfenadine, ranolazine, domperidone.
- •Complete branch block
- •Hypovolemia
- •Retinopathy including vitreous involvement
- •Psoriasis
- •Pregnant or breastfeeding woman
- •hypersensitivity to chloroquine or hydroxychloroquine or to any of the other ingredients of this medication
研究组 & 干预措施
HCQ+Azithromycin+Zinc
Experimental
- HCQ: 600 mg on the 1st day as a starting dose then 200 mg * 2 / D for 9 days
- Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
- Zinc: 220 mg per day for 10 days
- Usual standard treatment
干预措施: Azithromycin (Drug)
HCQ+Azithromycin
Experimental
- Hydroxychloroquine (HCQ): 600 mg on the 1st day as a starting dose then 200 mg * 2 / D for 9 days
- Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
- Usual standard treatment
干预措施: HCQ (Drug)
HCQ+Azithromycin
Experimental
- Hydroxychloroquine (HCQ): 600 mg on the 1st day as a starting dose then 200 mg * 2 / D for 9 days
- Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
- Usual standard treatment
干预措施: Azithromycin (Drug)
HCQ+Azithromycin+Zinc
Experimental
- HCQ: 600 mg on the 1st day as a starting dose then 200 mg * 2 / D for 9 days
- Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
- Zinc: 220 mg per day for 10 days
- Usual standard treatment
干预措施: HCQ (Drug)
HCQ+Azithromycin+Zinc
Experimental
- HCQ: 600 mg on the 1st day as a starting dose then 200 mg * 2 / D for 9 days
- Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
- Zinc: 220 mg per day for 10 days
- Usual standard treatment
干预措施: Zinc (Dietary Supplement)
Azithromycin+Doxycycline
Experimental
- Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
- Doxycycline: 200 mg per day for 10 days.
- Usual standard treatment
干预措施: Azithromycin (Drug)
Azithromycin+Doxycycline
Experimental
- Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days
- Doxycycline: 200 mg per day for 10 days.
- Usual standard treatment
干预措施: Doxycycline (Drug)
结局指标
主要结局
Evaluate the rate of patients cured at the end of the study.
时间窗: 2 months
The healing criteria are defined clinically as: disappearance of clinical signs of acute respiratory infection absence of fever
Evaluate the rate of patients are pauci-symptomatic at the end of the study.
时间窗: 2 months
A patient will be defined as pauci-symptomatic if presence: * Light dry cough * Discomfort, * More or less : * Headache, * Muscle pain
次要结局
- Evaluate the rate of patients with worsening clinical signs(2 months)
研究者
Dr Jalila Ben Khelil
Head of department
Abderrahmane Mami Hospital
研究点 (1)
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