Efficacy of Ivermectin in Outpatients With Non-severe COVID-19: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Proportion of patients with hospitalization criteria
研究概览
简要总结
This is a randomized controlled trial to evaluate the efficacy of ivermectin in reducing the risk of progression to severe disease and hospitalizations in COVID-19 patients.
详细描述
This is a randomized controlled trial to evaluate the efficacy of ivermectin in COVID-19 outpatients reducing the risk of progression to severe disease.
Patients with COVID-19 infection are randomized to receive a single dose of 200mcg/kg of ivermectin or a placebo.
The randomization code is generated by the trial statistician. The allocation is made after fulfilment of both inclusion and exclusion criteria.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple (Participant, 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
- •Positive diagnostic RT-qPCR or antigen test for SARS-CoV-2
- •Symptomatic patients with up to 8 days from the onset of symptoms, and asymptomatic cases with up to 5 days of positive test for SARS-CoV-
- •Patients who agree to participate in the study by signing the informed consent.
排除标准
- •Patients with severity criteria defined in the Coronavirus Disease Epidemiological and Laboratory Surveillance Guide (Version 3/11/2020)
- •Pregnant or breastfeeding women
- •Women of childbearing age and without commitment to use contraceptive methods during the study time.
- •Inability to complete the study
- •Current treatment with drugs known to interact with ivermectin
- •Known intolerance to ivermectin, its derivate or any of its excipients.
- •Patients with known Child-Pugh C liver disease
- •Patients with prior ivermectin consumption in the 10 days prior to study entry.
研究组 & 干预措施
Ivermectin
Ivermectin 200mcg/kg single dose, maximum dose 18mg
干预措施: Ivermectin Tablets (Drug)
Placebo
Inactive medication tablets indistinguishable from ivermectin tablets
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of patients with hospitalization criteria
时间窗: 30 days
Proportion of patients with hospitalization criteria at day 30
次要结局
- Drug-related adverse events(30 days)
- Proportion of patients with COVID-19 signs and symptoms(14 days)
- Proportion of cohabitants who had COVID-19 after the index case(30 days)
- Levels of IgG for SARS-CoV-2(30-60 days)