EUCTR2021-002024-21-CZ进行中（未招募）1 期
Randomized placebo controlled clinical trial evaluating the safety and efficacy of ivermectin in hospitalized patients with Covid-19 disease
Fakultní nemocnice u sv. Anny v Brne0 个研究点目标入组 136 人开始时间: 2021年4月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 136
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
- •1) Age = 18 years
- •2) Willingness to participate in the clinical trial expressed by signing the informed consent form
- •3) Patients with confirmed Covid-19 disease requiring hospitalization with at least one of the following symptoms:
- •a. febrile illness above 38.5 ° C;
- •b. shortness of breath at rest or with minimal exertion,
- •c. oxygen-free saturation below 93 % SpO2,
- •d. inability to self-service, general exhaustion and more
- •4) Laboratory PCR confirmed positivity SARS-CoV-2 (nasopharyngeal swab) or positive antigen test not older than 5 days.
- •5) Clinical trial subjects of childbearing potential must agree to the use of the following methods of contraception for the duration of clinical trial and 3 months after the end of clinical trial.
- •a. For women of childbearing potential using one of the following methods:
- •i. highly reliable contraceptive methods within 3 months after end of clinical trial: combined hormonal contraception (oral, vaginal, transdermal), progesterone-containing contraceptives with ovulation inhibition (oral, injection), intrauterine non-hormonal or hormonal body, bilateral tubal occlusion or partner vasectomy
- •ii. sexual abstinence if it is consistent with the lifestyle of the subject.
- •b. For men, use one of the following methods: observance of sexual abstinence (if it is consistent with the lifestyle of the subject) or use of an adequate contraceptive method (ie condom) in the case of sexual intercourse within 3 months after the end of clinical trial.
- •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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •1) Pregnancy, breastfeeding, positive chorionic gonadotropin (hCG)
- •2) Inadequacy of classification of the subject on the basis of individual assessment of the examining physician
- •3) Age <18 years
- •4) Outpatient treatment of patients with Covid-19 disease
- •5) Hepatic impairment - alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST)> 3x ULN detected before IP administration
- •6) Known hypersensitivity to the components of the preparation
- •7) Eating and fluid intake disorders and conditions limiting the bioavailability of the drug
- •8) Participation in another clinical trial
- •9) BMI > 35
- •10) Inability to swallow drugs
- •11) Current use of potent CYP3A4 inhibitors: fluconazole, fluoxetine, indinavir, itraconazole, clarithromycin, nifedipine, ritomavir, verapamil, voriconazole
- •12) Use of ivermectin 1 month before inclusion in CT
- •13) Bone marrow transplantation, history of hematopoietic disorders
- •14) Neurological disorders such as epilepsy that are treated with GABA agonists, such as baclofen, or past suicidal ideation or attempts
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