NCT04405843已完成2 期
Randomized, Placebo Controlled, Double Blind Clinical Trial to Evaluate the Efficacy of Molecule D11AX22 in Adults Patients From Valle Del Cauca, Colombia With Early Stages of SARS COV2 / COVID-19
Centro de Estudios en Infectogía Pediatrica1 个研究点 分布在 1 个国家目标入组 476 人开始时间: 2020年7月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 476
- 试验地点
- 1
- 主要终点
- Time to event
研究概览
简要总结
Double blind, placebo controlled, randomized clinical trial to evaluate the efficacy of ivermectin in preventing progression of disease in adult patients with early stages of COVID-19
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
- •At least 18 years of age
- •Confirmed SARS-CoV-2 by RT-PCR or antigen detection in a Colombian NIH-approved laboratory
- •Beginning of symptoms in the past 7 days
- •Mild disease
- •Informed consent
排除标准
- •Preexisting liver disease
- •Hypersensitivity to ivermectin
- •Participants in other clinical trials for therapies against COVID-19
- •Severe pneumonia
- •Pregnant or breastfeeding women
- •Concomitant use of warfarin, erdafitinib or quinidine
- •Use of ivermectin in the 5 days prior to randomization
- •Inability to obtain a blood sample needed to assess liver transaminases
- •Elevation of transaminases >1.5 times the normal level
- •Participant whose first contact with the study personnel occurs between days 5 and 7 and at that time manifests significant and progressive resolution of COVID-19 related signs and symptoms
研究组 & 干预措施
Ivermectin
Experimental
Ivermectin, 300 micrograms / kg, once daily for 5 days
干预措施: Ivermectin Oral Product (Drug)
Placebo
Placebo Comparator
Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient
干预措施: Placebo (Drug)
结局指标
主要结局
Time to event
时间窗: 21 days
Time until resolution of symptoms
次要结局
- Clinical condition on day 5(On day 5 (± 1 day) after randomization)
- Proportion of subjects who discontinue intervention(21 days)
- Time to event(21 days)
- Duration of fever(21 days)
- Clinical condition on day 2(On day 2 (± 1 day) after randomization)
- Clinical condition on day 8(On day 8 (± 1 day) after randomization)
- Clinical condition on day 11(On day 11 (± 1 day) after randomization)
- Clinical condition on day 15(On day 15 (± 1 day) after randomization)
- Clinical condition on day 21(On day 21 (± 1 day) after randomization)
- Proportion of subjects with additional care(21 days)
- Proportion of subjects who die(From randomization up to 21 days)
- Duration of additional care(21 days)
- Adverse events(21 days)
研究者
研究点 (1)
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