Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effect of aaPRP on pro-inflammatory cytokines plasma level (IL-6, IL-1B, TNFa, IFN gamma, MCP-1) before and after intervention compared to control.
研究概览
简要总结
The positive cases of coronavirus disease-2019 (COVID-19) in Indonesia has been increasing rapidly since the first case found in March 2020 to date. Coronavirus 2 (SARS-CoV-2) virus disrupts human normal immune system resulting in uncontrolled inflammatory response. Based on our research and experience in doing cell therapy for 9 years, activated platelet-rich plasma (PRP) produces anti-inflammatory effects in inflammatory condition that is beneficial for tissue regeneration. In this study, we aimed to evaluate the potential of autologous activated platelet-rich plasma (aaPRP) and the outcomes for treating severe Coronavirus Disease-2019 (COVID-19) patients in Intensive Care Unit (ICU).
详细描述
PRP decreases IL-1β, IL-6, IL-8, and TNFα inflammatory genes expression while also reduces IL-1β and TNFα inflammatory cytokines production. PRP has also been showed to contain interleukin 1 receptor antagonist (IL-1RA), an anti-inflammatory cytokines that suppress IL-6 secretion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe covid-19 patient in ICU
排除标准
- •CKD on hemodialysis, HIV positive, hepatitis, pregnant, destroyed lung, cancer
研究组 & 干预措施
Control
Only received standard medication (avigan) for severe COVID-19 management
干预措施: Avigan (Drug)
PRP Group
received standard medication (avigan) for severe COVID-19 management and autologous activated platelet-rich plasma transfusion
干预措施: autologous activated platelet-rich plasma (Combination Product)
PRP Group
received standard medication (avigan) for severe COVID-19 management and autologous activated platelet-rich plasma transfusion
干预措施: Avigan (Drug)
结局指标
主要结局
Effect of aaPRP on pro-inflammatory cytokines plasma level (IL-6, IL-1B, TNFa, IFN gamma, MCP-1) before and after intervention compared to control.
时间窗: 6 days
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
Effect of aaPRP on overall adverse event related to the treatment.
时间窗: 6 days
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
to evaluate the change of Effect of aaPRP on anti-inflammatory cytokines plasma level (IL-1RA, IL-4, IL-10) before and after intervention compared to control.
时间窗: 6 days
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
Effect of aaPRP on CRP level before and after intervention compared to control.
时间窗: 6 days
Patients with positive COVID19 who will improve after receiving aaPRP compared to control.
次要结局
- Effect of aaPRP on duration of hospitality of patient compared to control(6 days)
- Effect of aaPRP on Thorax X-ray image pre and post intervention between control and aaPRP-treated group(6 days)