A Placebo-controlled, Randomized, Double-blind Study in COvid-19 Patients With iveRmectin; An inVEstigator iniTiaTEd Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) Period until the COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) becomes negative
研究概览
简要总结
Treatment of mild COVID-19 is basically performed at an outpatient clinic, then when the symptom and clinical findings exacerbate to a moderate level, patients are admitted. There is no standard treatment for mild cases. This study will investigate whether ivermectin administration suppresses the replication of SARS-CoV-2 in mild to moderate COVID-19 by investigating the negative rate of SARS-CoV-2 PCR by a randomized controlled trial. Subjects are assigned to two groups, the placebo group, and the ivermectin group. The target number of each treatment arm is 120, a total of 240 cases. A single oral administration of 200 ㎍/kg of ivermectin or an ivermectin-free placebo will be administered on an empty stomach. Time to negativization of SARS-CoV-2 PCR as the primary endpoint with additional efficacy and safety of the process will be investigated.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A person who has been diagnosed with COVID-19 (including asymptomatic) by the COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) within 3 days before the qualification test.
- •A person with oxygen saturation (SpO2) in the room air of 95% or more.
- •A person who are 20 years or older at the time of obtaining consent.
- •A person who weigh 40 kg or more at the time of qualification test.
- •A person who understands the content of this clinical trial and can obtain written consent to participate in the clinical trial.
排除标准
- •A woman who is in lactation period or who may be pregnant, or those who do not agree to prevent pregnancy by medically appropriate means for up to 7 days after study drug administration.
- •Medically appropriate contraception means that using a combination of two or more of the following: not having sexual intercourse, taking surgical sterilization such as vasectomy or intrauterine device, taking oral contraceptive, using condom.
- •A person who has severe liver damage (AST or ALT at the time of qualification test is more than 3 times the upper limit of institutional standard and total bilirubin is more than twice the upper limit of institutional standard value), renal disorder (eGFR of eligibility test value 30 mL/min/1.73m2 or less).
- •A person with hypersensitivity to ivermectin.
- •A person with a history of severe drug allergies such as Stevens-Johnson syndrome, toxic epidermal necrolysis.
- •A person who has received the prohibited medication within the past month (within the past 6 months for biologics), or those who need to use the prohibited medication during the clinical trial period.
- •Those who are scheduled to receive SARS-CoV-2 vaccination from the date of consent to the end of the follow-up period.
- •A person who are currently participating in other clinical trials or who have participated in other clinical trials within 30 days before obtaining consent.
- •In addition, a person who is determined to be unsuitable as a subject of this clinical trial by the principal investigator."
研究组 & 干预措施
ivermectin
Ivermectin group: Ivermectin approximately 200 μg/kg administered as a single oral dose on Day 1 (fasting state) subjects take the study drug (3 mg tablet of ivermectin) at the dose of the study drug taken once per body weight of the subject.
干预措施: Ivermectin 3 MG (Drug)
placebo
Placebo group: Placebo without ivermectin as an ingredient, single oral administration on Day 1 (fasting state) the control drug (ivermectin placebo tablet) at the dose of the study drug taken once per body weight of the subject.
干预措施: Placebo (Drug)
结局指标
主要结局
COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) Period until the COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) becomes negative
时间窗: 15days
Period until the COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) becomes negative
次要结局
未报告次要终点
研究者
KUNIHIRO YAMAOKA
KitasatoUniversity SchoolofMedicine Professor
Kitasato University