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: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment

•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.

•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.

发起方

Center of Molecular Immunology (CIM)