Expanded clinical use of CIGB-258 in the treatment of serious or critically ill patients by COVID-19 (COVID-19)

Center for Genetic Engineering and Biotechnology (CIGB), in Havana0 个研究点开始时间: 2020年6月22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: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•1) Virological diagnosis by PCR-RT of infection to SARS-CoV-2.
•2) Patients with confirmed respiratory distress / multifocal interstitial pneumonia.
•3) Need for oxygen therapy to maintain SO2> 93%.
•4) Worsening of lung involvement, defined as one of the following criteria: a) Worsening of oxygen saturation > 3 percentage points or decrease in PaO2 > 10%, with stable FiO2 in the last 24 hours; b) Need to increase FiO2 in order to maintain stable SO2 or new need for mechanical ventilation in the last 24 hours; c) Increase in the number and / or extension of the lung consolidation areas.
•5) Patients in whom a clinical condition prior to hyperinflammation is suspected, according to the following criteria: a) sustained fever above 38 combined with criteria 2 or 3 and 4; b) dyspnea requiring oxygen therapy by mask or nasal fork, to maintain an oxygen saturation above 93; c) polypnea greater than 25 ventilations per minute, requiring oxygen therapy by mask or nasal fork, to maintain an oxygen saturation above 93; d) choppy language that does not allow you to count to 10.
•6) Express voluntariness of the patient, family member or impartial witness.

发起方

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