Outpatient Use of Ivermectin in COVID-19
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Clinical Improvement
研究概览
简要总结
Covid 19, a novel coronavirus, causes infection that, while mild to moderate in many people, can lead to severe disease in a significant portion. Currently, it is expected that the majority, 81%, of patients with COVID-19 will have mild to moderate disease, with 14% having more severe disease (2). There exists a number of candidate drugs that may inhibit SARS-CoV-2 infection or progression of disease. Simple, safe and low-cost strategies that may be the best solution to inhibit infection and limit transmission and spread of infection.
Ivermectin is a drug initially synthesized and used as an anthelmintic. It has been found to have activity against several RNA viruses such as the SARS-CoV-2 by mechanisms that inhibit importin α/β-mediated nuclear transport that may prevent viral proteins from entering the nucleus to alter host cell function. A recent in vitro study showed that a single dose of ivermectin could kill COVID-19 in vitro within 48 hours. A recent multi-continent retrospective study of 1,400 patients demonstrated an association of ivermectin use with lower in-hospital mortality 1.4% versus 8.5%. Given these findings and its safety profile, cost and ease of administration, Ivermectin warrants study as a potential treatment to prevent progression of COVID 19 infection.
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, Care Provider, 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
- •Symptoms highly suspicious for COVID-
- •Age at least 18 years
- •Negative pregnancy test for women of child bearing age
- •Able to consent to participate in the study.
排除标准
- •Known history of Ivermectin allergy
- •Hypersensitivity to any component of Stromectol®
- •COVID-19 Pneumonia identified by chest X-ray or high resolution CT scan
- •Fever or cough present for more than 7 days
- •Positive IgG against SARS-CoV-2 by rapid test if available on baseline screening.
- •The following co-morbidities (or any other disease that, in the opinion of the investigators, might interfere with the study:
- •Immunosuppression
- •Acute or chronic renal failure
- •Current neoplasm
- •Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal within the prior 6 months if available OR clinical evidence of liver failure with jaundice, ascites, encephalopathy.
- •Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin.
研究组 & 干预措施
Ivermectin
Single dose of 0.15-2 mg/kg/dose to a maximum of 12 mg
干预措施: Ivermectin Pill (Drug)
Placebo
Single dose of 2-4 placebo pills
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Improvement
时间窗: 28 days
Clinical Improvement as measured by the inFLUenza Patient-Reported Outcome (FLU-PRO)
次要结局
未报告次要终点