Evaluation of the Impact of the Administration of Single Dose of Ivermectin in the Early Phase of COVID-19 on the Time to Negativation of the SARS-COV-2 Viral Load Determinated by RT-PCR
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- negativation of the RT-PCR test on nasopharyngeal samples of SARS-CoV-2
研究概览
简要总结
The action of ivermectin in vitro on the viral replication of SARS-CoV-2 was demonstrated and published by an Australian team in June 2020. On the other hand, the doses to be administered in vivo to reach the concentrations described in vitro would lead to toxicities especially neurological, in treated patients, . However, some trials and studies, such as the ICON3 study, demonstrate the clinical efficacy of ivermectin administered at lower doses (200 µg / kg) in hospitalized patients with COVID-19.
The use of ivermectin in the early stages of the disease has not yet been studied. The administration of the maximum authorized dose (MA) of ivermectin could at least slow down the replication of the virus in vivo before the inflammatory phase of COVID-19, and reduce the duration of symptoms as well as the risk of hospitalization of patients, especially in critical care.
Unlike other studies conducted so far on COVID-19, IVERCoV will target the "viral" phase of the disease by screening patients in the city. In addition, home visits (symptom recording +/- PCR) will make it easier to monitor patients during the study.
详细描述
The action of ivermectin in vitro on viral replication of SARS-CoV-2 was demonstrated and published by an Australian team in June 2020. On the other hand, the doses to be administered in vivo making it possible to reach the concentrations described in vitro would result in toxicities in treated patients, especially neurological. However, some trials and studies, such as the ICON3 study, demonstrate the clinical efficacy of ivermectin administered at lower doses (200 µg / kg) in hospitalized patients with COVID-19.
The use of ivermectin in the early stages of the disease has not yet been studied. The administration of the maximum authorized dose (MA) of ivermectin could at least slow down the replication of the virus in vivo before the inflammatory phase of COVID-19, and reduce the duration of symptoms as well as the risk of hospitalization of patients, especially in critical care.
Unlike other studies conducted so far on COVID-19, IVERCoV will target the "viral" phase of the disease by screening patients in the city. In addition, home visits (symptom recording +/- PCR) will make it easier to monitor patients during the study.
Prospective, multicenter, double-blind, randomized trial in two parallel groups:
- a control group: with administration of a placebo in addition to the usual treatment
- an experimental group: treated with ivermectin 400 µg / kg in addition to the usual treatment.
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, Investigator, Outcomes Assessor)
盲法说明
Patients will be randomized into one of two groups in a 1: 1 ratio The randomization will be centralized and carried out electronically by IWRS.
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
- •patient ≥ 18 years old,
- •symptomatic COVID-19 for less than 96 hours (see list of symptoms in appendix),
- •tested positive for SARS-CoV-2 by RT-PCR on a nasopharyngeal sample within 48 hours of inclusion,
- •following an effective method of contraception for women of childbearing age,
- •affiliated to a social security scheme,
- •informed and written consent from patient.
排除标准
- •patient requiring normal hospitalization or intensive care
- •oxygen-requiring patient,
- •with a history of parasitosis, in particular filariasis,
- •with a history of hypereosinophilia,
- •notion of recent travel (less than 3 months) in poor hygienic conditions
- •taking ivermectin in the last 12 months,
- •contraindications to ivermectin or one of the constituents of the drug (known history of allergies),
- •pregnant or breastfeeding women,
- •participation in another interventional study relating to COVID-19 concerning a drug during this research,
- •patient under AME or without social security coverage.
研究组 & 干预措施
Ivermectin
Ivermectin 3mg, on tablet. As a single dose of 400 µg / kg orally (rounded down to the nearest unit). T+ usual care
干预措施: Ivermectin (Drug)
control
placebo of ivermectin administered in the same manner as the active drug in experimental arm + usual care
干预措施: Ivermectin (Drug)
结局指标
主要结局
negativation of the RT-PCR test on nasopharyngeal samples of SARS-CoV-2
时间窗: Day 3
negativation of the RT-PCR test on nasopharyngeal samples of SARS-CoV-2 on D3 of taking Ivermectin compared to the control group (placebo).
次要结局
未报告次要终点