Randomized control clinical trial of CIGB 2020 in contacts and SARS-CoV-2 infection suspects (COVID-19)

Center for Genetic Engineering and Biotechnology (CIGB), in Havana0 个研究点目标入组 80 人开始时间: 2020年4月13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: Other

•1- Age equal to or greater than 60 years, of both sexes.
•2- Cases defined as contact or suspected of SARS-CoV-2 infection.
•3- Voluntary nature of the subject to participate expressed through the delivery of signed informed consent.

•1-Established lung disease, pneumonia defined by imaging.
•2- Serious evolution of SARS-CoV-2 infection (extrapulmonary systemic hyperinflammation syndrome).
•3- AST or ALT> 2 times normal value.
•4- Abnormal bilirubin (total bilirubin> 1.2 mg / dL, direct bilirubin> 0.4 mg / dL).
•5- Creatinine> 2.0 mg / dl.
•6- Use of immunosuppressive drugs within 1 month of recruitment, or chemotherapy.
•7- Hemoglobin <10 g / dl.
•8- Platelets <100,000 / ml.
•9- History of allergy to any of the ingredients of the vaccine under study.
•10- Presence of mental and / or psychiatric disorders that make it impossible to sign the informed consent or to monitor the patient.

发起方

Center for Genetic Engineering and Biotechnology (CIGB), in Havana