Effectiveness and Safety Profile of Mesenchymal Stem Cell Secretomes as a Treatment for Severe Cases of COVID-19
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Assessment of inflamation marker levels
研究概览
简要总结
This study is a multi-centre randomized controlled trial involving severe covid-19 patients. The intervention group will receive mesenchymal stem cell secretomes and standard covid-19 therapy, while the control group receive placebo and standard covid-19 therapy. Clinical presentation, inflamatory marker, laboratory and radiological parameters, RT-PCR conversion, safety profile, and mortality rate will be monitored for a maximum of 14 days after intervention.
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
- •All individuals aged 18 to 65 years
- •It has been confirmed positive for COVID-19 by throat swab / sputum / brochoalveolar lavage (BAL) with real-time reverse transcription polymerase chain reaction (RT-PCR)
- •Categorized as a severe case of COVID-19 patient
- •Agree to participate and sign the informed consent
排除标准
- •History of allergy to penicillin, streptomycin, and amphotericin-B
- •Have any cancer conditions
- •Active in other intervention studies
- •Have had other intervention studies in the last 3 months
研究组 & 干预措施
Secretome - mesenchymal stem cell group (n = 20)
This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy
干预措施: Injection of secretome - mesenchymal stem cell (Biological)
Secretome - mesenchymal stem cell group (n = 20)
This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy
干预措施: Standard treatment of Covid-19 (Drug)
Control ( n= 20)
This group will be given placebo and COVID-19 standard therapy
干预措施: Placebo (Other)
Control ( n= 20)
This group will be given placebo and COVID-19 standard therapy
干预措施: Standard treatment of Covid-19 (Drug)
结局指标
主要结局
Assessment of inflamation marker levels
时间窗: Day 0 (before intervention), day 7, day 14
The inflamatory marker assessed in this study is IL-6, IL-10, LIF, VEGF, and Ferritin. The inflamatory marker level will assess on day 0 (before intervention), day 7 after intervention, and day 14 after intervention.
次要结局
- Mortality rate(maximum 14 days after intervention)
- Assessment of clinical outcome(before and after intervention (maximum 14 days after intervention))
- Assessment of photo thorax(before and after intervention (maximum 14 days after intervention))
- Assessment of RT-PCR conversion(before and after intervention (maximum 14 days after intervention))
- Assessment of laboratory routine(before and after intervention (maximum 14 days after intervention))
研究者
Murdani abdullah
Prof. M.D., PhD, FACG, FASGE
Indonesia University