Proof of Concept, Multicentre, Parallel, Randomized, Double-blind Clinical Trial to Assess the Safety and Efficacy of Nitazoxanide 600 mg Compared to Placebo in the Treatment of Hospitalized Patients With COVID-19 in Moderate Condition.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Viral load
研究概览
简要总结
This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19.
详细描述
This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19.
The aim is to demonstrate a decrease in hospital related complications among patients who are hospitalized with moderate COVID-19 by treating them with nitazoxanide for 7 days on top of standard care compared to patients who receive standard care and placebo.
Patients hospitalized with confirmed diagnosis of COVID-19 will be randomized to receive either nitazoxanide or placebo.
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
- •Informed consent from patient or legal representative.
- •Male or female, aged ≥ 18 years;
- •Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
- •Signs of respiratory failure requiring oxygen therapy
- •Hospitalized for up to 36h with non-invasive ventilation
- •Negative result for pregnancy test (if applicable).
排除标准
- •Participating in another RCT in the past 12 months;
- •Known allergy to nitazoxanide
- •Severely reduced LV function;
- •Severely reduced renal function;
- •Pregnancy or breast feeding;
- •Use of hydroxychloroquine and/or azithromycin in the past 15 days;
- •Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products
研究组 & 干预措施
nitazoxanide
Patients will receive nitazoxanide 600 mg BID for 7 days.
干预措施: Nitazoxanide Tablets (Drug)
Placebo
Patients will receive placebo BID for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Viral load
时间窗: day 1, 4, 7, 14 and 21
PCR will be done to evaluate the change in viral load
次要结局
- Change in Clinical Condition(21 days)
- Need of mechanical ventilation(21 days)
- Evolution of acute respiratory syndrome(21 days)
- Rate of mortality within 21-days(21 days)
- Hospital discharge(21 days)