Safety and effect of CIMAvax-EGF® in convalescent patients from SARS-CoV-2 infection with respiratory disorders. Phase II (COVID-19) - CORVAXCIM

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. Subject of any sex and age greater than or equal to 18 years.
•3. Subjects for whom at least 14 days have elapsed from discharge from the post-COVID-19 patient care service or referral of the specialized consultation.
•4. Patients with respiratory clinical manifestations and deterioration of respiratory function due to spirometric or radiological functional pattern.
•5. Subject that in the pre-inclusion checkup they have: hemoglobin = 9 g/L, leukocytes = 3.4x109 L, absolute neutrophil count = 1.5 x 109 L.
•6. Liver and kidney function tests in normal ranges.

•1. Patients with pre-existing lung disorders (including pulmonary fibrosis, COPD, severe asthma, lung cancer, etc).
•2. Patients with confirmed severe or life-limiting chronic disease, or a history of angioedema prior to COVID-19 infection.
•3. Pregnancy or lactation period.
•4. Subjects of childbearing age who are not using an adequate method of contraception prior to their inclusion in the study.
•5. Subject that they are receiving another product under investigation.
•6. Known hypersensitivity to any of the components of the formulation under study.
•7. Obvious mental incapacity to issue consent and act accordingly with the study.

发起方

Center of Molecular Immunology (CIM)