EUCTR2020-001606-33-ES进行中（未招募）1 期
Randomized clinical trial to evaluate the efficacy of hydroxychloroquine associated or not with azithromycin as a treatment for COVID-19 infection. - Randomized clinical trial to evaluate the efficacy of a treatment for COVID-19 infection
Instituto Investigación Sanitario Biocruces Bizkaia0 个研究点目标入组 132 人开始时间: 2020年4月7日最近更新:
适应症
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
- 132
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
- •- Patients of both sexes
- •- Patients = 18 years with COVID and comorbidities (COPD, asthma, heart disease, HT, diabetes, neoplasia, chronic liver disease or with immunosuppressive treatment), without pneumonia or over 60 with COVID
- •- SARS-CoV-2 infection confirmed by PCR test
- •- Radiographic evidence of not presenting pneumonia
- •- O2 saturation> 92%
- •- Respiratory Rate <20 rpm
- •- Willing and able to sign the written informed consent before carrying out the study procedures. Exceptionally, oral consent is admitted, preferably before independent witnesses, documenting it in the medical record and provided that it can later be ratified.
- •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 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 62
排除标准
- •- Participation in any other clinical trial with an experimental treatment for COVID-19
- •- Hypersensitivity to the active substance, to 4-aminoquinoline compounds or to any of the excipients included in section 6.1 of the hydroxychloroquine data sheet
- •- Hypersensitivity to azithromycin, erythromycin, any other macrolide or ketolide antibiotic or to any of the excipients listed in section 6.1 of the azithromycin SmPC
- •- psoriasis
- •- Patients with glucose-6-phosphate dehydrogenase deficiency
- •- Any contraindication according to the Technical Data Sheet of Hydroxychloroquine and Azithromycin
- •- pneumonia
- •- Myasthenia gravis
- •- Pre-existing maculopathy of the eye
- •- Presence of changes in acuity or visual field
- •- QT +/- 450 extension
- •- ALT or AST> 5 x ULN
- •- Creatinine clearance <50 ml / min
- •- Positive pregnancy test
- •- Woman with breastfeeding
- •- Active treatment with: artemeter / lumefantrine, mefloquine, natilizumab, live attenuated virus vaccines, pimecrolimus, tacrolimus (topical), mosifloxacin, and agalsidase alpha and beta
- •- Refusal by the patient to accept the commitment to comply with the procedures indicated during the research process
研究者
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