RPCEC00000411尚未招募2 期
Evaluation of the effect and safety of Jusvinza in severe patients with Acquired Community Pneumonia - VINSENT
Center for Genetic Engineering and Biotechnology (CGIB), the Havana0 个研究点目标入组 60 人开始时间: 2022年10月14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
- 60
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: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 one（—）
- 性别
- All
入选标准
- •1. Patients with Age = 18
- •2. Willingness of the patient through the signing of the informed consent.
- •3. Patients with diagnosis of SACP (Severe Acquired Community Pneumonia).
排除标准
- •1. Patient with Septic Shock.
- •2. Patient with Severe Acute Respiratory Distress Syndrome.
- •3. Hospitalized patient with a diagnosis of CAPg of more than 48 hours of evolution.
- •4. Patient with prior treatment with JAK inhibitor, tocilizumab or other anti-IL6R or IL-6 inhibitor, IL-1 (Anakinra), Nimotuzumab and Itolizumab.
- •5. Patients with significant deterioration of their underlying chronic disease that compromise imminent survival: diseases such as unresectable tumors, hematological diseases, Alzheimer's disease or AIDS, terminal chronic respiratory diseases requiring permanent oxygenation, prolonged bed rest due to cerebrovascular diseases.
- •6. Obese patients (Body Mass Index > 30 kg/m2).
- •7. Patient with Chronic Kidney Disease undergoing hemodialysis.
- •8. Hypersensitivity to the product or any of its components.
- •9. Patients with steroid use at immunosuppressive doses greater than 20 mg daily of Prednisone or equivalent.
- •10. Psychiatric patients.
- •11. History of SACP 30 days prior to inclusion.
- •12. Pregnancy or lactation.
研究者
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