RPCEC00000376尚未招募2 期
Safety and effect of ior®EPOCIM in convalescent patients from SARS-CoV-2 infection with cardiovascular, renal and/or respiratory sequelae. (COVID-19) - COREPOCIM
Center of Molecular Immunology (CIM)0 个研究点目标入组 135 人开始时间: 2021年6月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 one（—）
- 性别
- All
入选标准
- •1. Willingness of the patient by signing the informed consent.
- •2. Subjects of any sex over 18 years of age.
- •3. Subjects who in the run-in check have hematocrit = 40 and higher hemoglobin = 9 g / L and =14g / L.
- •4. Subjects who maintain liver function tests in normal ranges or out of range in the pre-inclusion check-up without imminent compromise for life (clinical signs of hepatic encephalopathy and / or uremic coma).
- •5. Patients with cardiovascular sequelae, classified as classes II-III according to the functional scale of the New York Health Association (NYHA).
- •6. Patients with kidney sequelae with mild to moderate damage, according to the functional scale of the Kidney Disease Improving Global Outcome (KDIGO).
- •7. Patients with respiratory clinical manifestations and deterioration of respiratory function due to spirometric or radiological functional pattern.
- •8. Subjects of childbearing age who are using an adequate method of contraception prior to their inclusion in the study.
排除标准
- •1. Pregnant or lactating women.
- •2. Patients with a history of thromboembolic disease in the last 3 to 6 months.
- •3. Patient with pre-existing cardiovascular diseases.
- •4. Patients with pre-existing renal failure, or undergoing treatment with extracorporeal clearance methods prior to SARS-CoV-2 infection.
- •5. Patients with pre-existing lung sequelae (including pulmonary fibrosis, COPD, severe asthma, lung cancer, etc.).
- •6. Patients with confirmed serious or life-limiting chronic disease.
- •7. Known hypersensitivity to any of the components of the formulation under study.
- •8. Subject that they are receiving another product under investigation.
- •9. Patients with obvious mental incapacity to give consent and act accordingly with the study.
研究者
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