Randomized, Double-blind, Multi Centre Phase II, Proof of Concept, Dose Finding Clinical Trial on Ivermectin for the Early Treatment of COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 93
- 试验地点
- 5
- 主要终点
- SADR
研究概览
简要总结
Prospective, multi-centre, randomized, double-blind trial to assess efficacy and safety of ivermectin for the treatment of initial infection with SARS-CoV2 infection.
Study arms: A) placebo B) ivermectin 600 μg/kg daily for 5 consecutive days (I_600) + placebo. C) ivermectin 1200 μg/kg daily at empty stomach with water for 5 consecutive days (I_1200). Patients will be randomized at emergency room of hospitals as well as at outpatient ambulatory care as well as at home, according to routine procedures of recruiting centres.
In arm A and B, the number of placebo tablets to be administered will be calculated by the study dedicated pharmacist considering the number of tablets that should be taken in case a patient with the same weight is assigned to arm C.
详细描述
Primary objectives
The study is aimed:
- at defining if ivermectin, administered at dosage of 600 μg/kg or 1200 μg/kg QD for five consecutive days is safe in patients with initial, asymptomatic or oligosymptomatic SARS_CoV-2 infection,
- at defining if ivermectin, administered at the dosage(s) found to be safe decreases the viral load of SARS-CoV-2 at Day 7.
Secondary objectives To assess
- the temporal profile of viral load at baseline, day 7, 14 and 30
- the time to clinical cure (for symptomatic patients)
- the proportion of patients with virological clearance at day 14 and 30.
- the hospitalization rate.
- the COVID-19 Severity Score at day 14 and 30
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Ivermectin and placebo treatment will be double blinded, i.e. the treatment will be unknown to both the subject and the treating physician. The hospital pharmacist will be unblinded to study treatment because in charge to prepare the study treatment according to randomization arm.
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
- •Age >=18 years
- •Positivity at RT-PCR per SARS_CoV2 (nasopharyngeal swabs)
- •Consent to participation to the study and to the processing of personal data
- •COVID-19 Severity Score < 3
- •Patient able to take oral drugs
排除标准
- •Pregnant or lactating women (pregnancy test not required, if doubt patient is excluded)
- •Subjects suffering from known CNS diseases
- •Lack of (or inability to provide) informed consent
- •Patient under dialysis
- •Any severe medical condition with a prognosis of < 6 months
- •Patients under warfarin treatment
- •Patients under antiviral treatment
- •Patients under chloroquine phosphate or hydroxychloroquine
研究组 & 干预措施
I_600
ivermectin 600 μg/kg daily for 5 consecutive days (I_600) + placebo
干预措施: Ivermectin (Drug)
I_1200
ivermectin 1200 μg/kg daily at empty stomach with water for 5 consecutive days
干预措施: Ivermectin (Drug)
Placebo
placebo
干预措施: Placebo (Other)
结局指标
主要结局
SADR
时间窗: 14 days
Number of serious adverse drug reaction
Viral load
时间窗: Assessed at day 7
Quantitative viral load as measured by quantitative, digital droplet PCR.
次要结局
- Clinical resolution(Assessed on Day 30)
- hospitalization rate(Day 30)
- Severity score(Assessed at Day 14 and Day 30)
- Viral clearance(assessed on days 14 and 30)
- Trend viral load(Days 7 and 14 from baseline)
- Virological clearance(Assessed at day 14 and 30)