NCT05305560已完成2 期
A Multicentre Randomised, Double-Blind, Placebo-controlled, Study to Evaluate the efficAcy and Safety of Oral IVErmectin Tablets in the Prevention of COVID-19
MedinCell S.A1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年3月25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
- 400
- 试验地点
- 1
- 主要终点
- COVID-19 Prophylaxis
研究概览
简要总结
A multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of oral ivermectin tablets versus placebo for COVID-19 prophylaxis
详细描述
This trial comprises a total observation period of up to 56 days (an on-treatment period of up to 28 days and a safety follow-up of up to 28 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years, inclusive.
- •Body weight >45 kg.
- •Body Mass Index >18.
- •Close contact with a person who has a PCR-confirmed SARS-CoV-2 infection within 5 days before screening.
- •Only one member in the same household will be enrolled.
- •Participants must be able to give informed consent and comply with the study's scheduled events/visits and study assessments.
- •SARS-CoV-2 positive index case must be able to give consent to enable collection of the documented positive PCR test.
- •Female participants of childbearing potential must use a highly effective method of contraception for the duration of the trial.
排除标准
- •Pregnant or breast-feeding.
- •Participants who have been administered COVID-19 vaccine prior to the inclusion or have a planned vaccination during the duration of the study.
- •A positive COVID-19 result (PCR or antigen test) within 8 days of screening.
- •Presence of typical COVID-19 symptoms (fever >38°C, SpO2 below 93%, dyspnoea, difficulty breathing, chills, repeated shaking with chills, ageusia, anosmia, cough, myalgia, headache) in the past 48 hours prior to screening.
- •Hypersensitivity to any component of ivermectin.
- •Participants who have been administered ivermectin within 30 days prior to screening.
- •Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first.
- •Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.).
- •History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors.
- •Current use of monoclonal antibodies for the treatment of COVID-19.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Matching placebo tablets (Drug)
Active IMP
Experimental
干预措施: Ivermectin Tablets (Drug)
结局指标
主要结局
COVID-19 Prophylaxis
时间窗: From Day 1 to Day 28
Number of laboratory-confirmed COVID-19 infections in each group between baseline and Day 28
次要结局
- COVID-19 Prophylaxis Timeframe(From Day 1 to Day 28)
- COVID-19 Hospitalisations(From Day 1 to Day 56)
- To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days(56 days)
- COVID-19 Symptoms Development(From Day 1 to Day 28)
- COVID-19 Mortality(From Day 1 to Day 56)
研究者
研究点 (1)
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