EUCTR2020-001760-29-ES进行中（未招募）1 期
Phase II clinical trial to evaluate the efficacy and safety of inhaled ethanol in the treatment of early-stage COVID-19. - ALCOVID-19
Sociedad Española de Farmacia Hospitalaria0 个研究点目标入组 156 人开始时间: 2020年11月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 156
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. Institutionalized men or women aged 65 or over at the time of signing the informed consent.
- •2. Patients capable of understanding the trial procedures and accepting their participation.
- •3. Diagnosis of COVID-19 confirmed by RT-PCR.
- •4. Initial stage of the disease diagnosed by:
- •- Less than 7 days from the appearance of the first symptoms.
- •- Absence of dyspnea
- •- Absence of pneumonia
- •- SO2> 93% or pO2> 70
- •- FR <25 rpm
- •5. Signature and date of informed consent before any study-related activity, including evaluations necessary for selection.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 156
排除标准
- •1. Impaired kidney function (creatinine> 2.5 times the normal limit), need for haemofiltration or impaired liver function (ALT or AST> 3 times the normal limits) or diagnosis of severe kidney failure.
- •2. Hypersensitivity, allergy or contraindications to the study treatments.
- •3. Inability to administer oxygen therapy using Ventimask®.
- •4. Diagnosis of any other pathology that, in the investigator's opinion, may increase the subject's risk or reduce the possibilities of obtaining satisfactory data to achieve the study's objectives.
- •5. Consumption of any other drug that could disable him in the judgment of the investigator to participate in the study.
- •6. Other circumstances or difficulties that, in the investigator's opinion, may increase the subject's risk or reduce the possibilities of obtaining satisfactory data to achieve the objectives of the study.
- •7. Participation in another clinical study where they received an investigational drug in the 24 weeks prior to signing the informed consent.
- •8. Patients diagnosed with chronic bronchopneumopathy.
- •9. Patients with a history of epilepsy.
- •10. Patients with a history of alcoholism.
- •11. Treatment with anticonvulsant drugs used for the treatment of epilepsy and with a higher degree of interaction with ethanol: topiramate, carbamazepine, perampanel and stiripentol
- •12. Treatment with drugs that administered concomitantly with ethanol can cause the so-called disulfiran-like effect”: disulfiran, metronidazole, tinidazole, chloramphenicol, levamisole, nitrofurantoin, isoniazid and griseofulvin.
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