EUCTR2020-001994-66-ES进行中（未招募）1 期
Ramdomised clinical trial of ivermectin for treatment and prophylaxis of COVID-19
Fundació Assistencial Mútua Terrassa0 个研究点目标入组 266 人开始时间: 2020年5月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 266
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Sub-study 1:
- •1. Symptomatic (respiratory) patients with a positive PCR-RT test for COVID-19 and a clinical condition of less than 5 days of evolution.
- •2. =18 years old.
- •3. In women of childbearing age, negative pregnancy test and use of contraceptive method during the study period.
- •4. Accept to take the medication and the complementary test procedures during the study, including analysis and nasal sampling.
- •5. Able to provide informed consent (oral or written).
- •Sub-study 2:
- •1. Contacts of symptomatic (respiratory) patients with a positive PCR-RT test for COVID-19 and a diagnosis of less than 5 days of evolution.
- •2. Of legal age.
- •3. In women of childbearing age, negative pregnancy test and use of contraceptive method during the study period.
- •4. Accept to take the medication and the complementary test procedures during the study, including analysis and nasal sampling.
- •5. Able to provide informed consent (oral or written).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 266
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Sub-study 1
- •1. Moderate or severe forms of infection requiring hospital admission
- •a.-Respiratory distress with respiratory rate> = 30 breaths / min
- •b.-Oxygen saturation =93% at rest
- •c.- Kirby index:(PaO2) /(FIO2)) =300mmHg.
- •2. Participants taking medications that may interfere with the study medication such as anticoagulants.
- •3. Inability to take oral medication.
- •4. Severe liver disorders (Child Pugh C).
- •5. Impairment of severe renal function (with GFR =30 mL / min / 1.73 m2) or requiring dialysis.
- •6. Participants with coagulation disorders.
- •7. Individuals with severe neurological or mental impairment.
- •8. Pregnant or lactating women.
- •9. Unable to consent to the study protocol.
- •10. People with known hypersensitivity to Ivermectin.
- •11. People who have been treated in any other study in the previous 30 days.
- •12. Concomitant administration of enzyme inducers (such as carbamazepine) that could affect the effectiveness of the drug and those receiving CYP3A4 substrates (such as statins) due to the risk of increased toxicity.
- •13. Any other contraindication according to the technical sheet for Ivermectin.
- •Sub-study 2
- •1. Participants taking medications that may interfere with study medication.
- •2. Inability to take oral medication.
- •3. Severe liver disorders (Child Pugh C) or alcoholism.
- •4. Impaired severe renal function (with GFR =30 mL / min / 1.73 m2) or requiring dialysis.
- •5. Participants with coagulation disorders.
- •6. Individuals with severe neurological or mental impairment.
- •7. Pregnant or lactating women.
- •8. Unable to consent to study protocol.
- •9. People with known hypersensitivity to Ivermectin.
- •10. People who have been treated in any other study in the previous 30 days.
- •11. Concomitant administration of enzyme inducers (such as carbamazepine) that could affect the effectiveness of the drug and those receiving CYP3A4 substrates (such as statins) due to the risk of increased toxicity.
- •12. Any other contraindication according to the technical data sheet for Ivermectin.
研究者
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