Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection and to Decrease Viral Shedding - A Double Blind , Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Viral clearance at day 6
研究概览
简要总结
Ivermectin which is an FDA-approved broad spectrum anti-parasitic agent, has also anti-viral activity. In vitro study have shown its activity against SARS-CoV-2, however its clinical effect on patients with COVID-19 never been tested.
In this RCT we would like to evaluate the effect of Ivermectin on reduction of viral shedding among mild to moderate COVID-19 patients, and in shortening the symptom resolution time.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants eligible for inclusion will include non-pregnant adult (>18 years old) with molecular confirmation of COVID-
- •[Participants will be eligible in a period of no longer than 72 hours after exposure].
排除标准
- •Severe infection ( defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support).
- •Weight below 40Kg or above 100Kg
- •Unable to take oral medication
- •Known allergy to the drugs
- •Pregnancy or breast feeding
- •Participating in another RCT for treatment of COVID-19.
研究组 & 干预措施
IVERMECTIN
干预措施: Ivermectin Oral Product (Drug)
PLACEBO
干预措施: Ivermectin Oral Product (Drug)
结局指标
主要结局
Viral clearance at day 6
时间窗: Outcome will be determined till 6 days post intervention
The primary outcome will be the viral clearance at day 6 in the intervention group compared to placebo.
Viral shedding duration
时间窗: Outcome will be determined till 14 days post intervention
Secondary outcomes: viral shedding duration (time between first positive PCR to last of two consecutive negative tests)
Symptoms clearance time
时间窗: Outcome will be determined till 14 days post intervention
Time between drug treatment and symptoms resolution
次要结局
未报告次要终点
研究者
Prof. Eli Schwartz MD, DTMH
Prinicipal Investigator
Sheba Medical Center