Phase 2 Clinical Trial to Compare the Efficacy and Safety of Different Doses of Ivermectin in Patients Diagnosed With the New Coronavirus Infection (SARS-CoV-2)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Undetectable viral load during 7 days of follow-up.
研究概览
简要总结
In December 2019, a group of patients with pneumonia of unknown cause was linked to a wholesale seafood market in Wuhan, China. The genetic analysis of samples from the lower respiratory tract of these patients indicated a new coronavirus as the causative agent, which was named SARS-CoV-2. The virus spread rapidly to more than 45 countries, including Brazil, causing an international alarm. However, in spite of its epidemiological magnitude, so far, there is no antiviral treatment or vaccine approved for the treatment of this infection. With about 15% to 20% of SARS-CoV-2 patients suffering from serious illnesses and overburdened hospitals, therapeutic options are desperately needed. So, instead of creating compounds from scratch that can take years to develop and test, researchers and public health agencies have sought to redirect drugs already approved for other diseases and known to be widely safe. In this context, the analysis of the international literature shows the existence of an in vitro antiviral activity of ivermectin against SARS-CoV-2. However, there are no studies that have evaluated its clinical effectiveness in patients diagnosed with SARS-CoV-2 infection. Therefore, and considering this knowledge gap, the present study aims to determine the clinical efficacy and safety of different doses of ivermectin in patients diagnosed with SARS-CoV-2 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
- None
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
- •Diagnosis of infection by SARS-CoV-2:
- •symptoms of acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath) and biomolecular diagnosis of SARS-CoV-2 infection; OR
- •any acute respiratory disease AND biomolecular diagnosis of SARS-CoV-2 infection; OR
- •severe acute respiratory infection (fever and at least one sign / symptom of respiratory disease eg cough, fever, shortness of breath) AND in need of hospitalization AND biomolecular diagnosis of SARS-CoV-2 infection;
- •Eastern Cooperative Oncology Group Performance Status score 0 to 1;
- •National Early Warning Score 0 to 4;
- •Ability to understand and consent to participate in this clinical trial, manifested by signing the Informed Consent Form (ICF).
排除标准
- •Inability to ingest / absorb the study drug orally through spontaneous ingestion or use of gastro / enteral tubes;
- •Any finding of clinical observation (history / physical evaluation) that is interpreted by the investigating physician as a risk to participate in the trial;
- •Any laboratory test findings that the investigating physician considers as a risk to the research participant as to his / her participation in the clinical study;
- •Any ECG examination finding that the investigating physician considers as a risk to the research participant as to his / her participation in the trial;
- •Known hypersensitivity to the components of the drugs used during the study;
- •Women in pregnancy or breastfeeding;
- •Body weight less than 15kg;
- •Estimated glomerular filtration rate (CKD-Epidemiology Collaboration, CKD-EPI) <30 mL / min;
- •Aspartate aminotransaminase (AST) or alanine aminotransaminase (ALT)> 5 times the upper limit of normality;
- •Refusal to participate;
- •Refusal to sign the informed consent form.
研究组 & 干预措施
Standard of care
Standard of care (SOC) treatment
干预措施: Standard of Care (Other)
SOC plus ivermectin 100 mcg/kg
SOC plus ivermectin 100 mcg/kg
干预措施: Ivermectin (Drug)
SOC plus ivermectin 200 mcg/kg
SOC plus ivermectin 200 mcg/kg
干预措施: Ivermectin (Drug)
SOC plus ivermectin 400 mcg/kg
SOC plus ivermectin 400 mcg/kg
干预措施: Ivermectin (Drug)
结局指标
主要结局
Undetectable viral load during 7 days of follow-up.
时间窗: 7 days following intervention
Proportion of patients who achieved undetectable viral load during 7 days of follow-up.
次要结局
- Viral load variation in the nasopharyngeal swab.(7 days following intervention.)
- Incidence of Treatment-Emergent Self-reported Adverse Events(28 days following intervention.)
- Incidence of Treatment-Emergent Laboratory-based Adverse Events(28 days following intervention.)
- Time to undetectable SARS-CoV-2 viral load in the nasopharyngeal swab.(7 days following intervention.)
研究者
Henrique Pott Junior
Professor
Universidade Federal de Sao Carlos