Effectiveness and Safety of Convalescent Plasma Therapy on COVID-19 Patients With Acute Respiratory Distress Syndrome in Referral Hospitals in Indonesia
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- All-cause mortality
研究概览
简要总结
Corona virus disease 2019 (COVID-19) has been declared as a Pandemic by the World Health Organization (WHO). According to WHO report on March 31st 2020, globally COVID-19 have infected over 750,000 people and caused over 36,000 deaths with case fatality rate of 4.85%. In Indonesia, COVID-19 have infected 1,414 people and caused 122 deaths with case fatality rate of 8.63%. In severe cases, COVID-19 causes complications, such as acute respiratory distress syndrome (ARDS), sepsis, septic shock, and multi-organ dysfunction syndrome (MODS), where age and comorbid illnesses as a major factor to these complications. Up to this point there are several promising therapies for COVID-19 but is not yet recommended and in need of further research. The use of convalescent plasma has been approved by the US Food and Drug Administration (FDA) through the scheme of emergency investigational new drug (eIND). This method has been used as the treatment in several outbreak or plague cases over the years, such as the flu epidemic in 1918, polio, measles, mumps, SARS (severe acute respiratory syndrome), EVD (Ebola virus disease) and MERS (middle-eastern respiratory syndrome) and this treatment shows better outcome. Several case report on the use of convalescent plasma for COVID-19 patients with ARDS and mechanical ventilation has been reported and shows promising outcome. Nevertheless, larger and multicenter research need to be done to assess and evaluate the effectiveness and safety of convalescent plasma therapy on for COVID-19 patients with ARDS.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged more than equal to 18 years.
- •COVID-19 confirmed by reverse transcriptase-polymerase chain reaction (RT-PCR)
- •Having severe pneumonia.
- •PAO2 / FIO2 <300.
排除标准
- •Contraindication to blood transfusions (fluid overload, history of anaphylaxis of blood products)
- •Multiple and severe organ failure, hemodynamically unstable
- •Other uncontrolled infections
- •Disseminated intravascular coagulation (DIC) which requires a replacement factor/FFP
- •Hemodialysis patients or CRRT (continuous renal replacement therapy)
- •Active intracranial bleeding
- •Significant myocardial ischemia
- •Receiving tocilizumab treatment
研究组 & 干预措施
convalescent plasma and standard of care
干预措施: Convalescent plasma (Biological)
convalescent plasma and standard of care
干预措施: Standard of care (Drug)
standard of care
干预措施: Standard of care (Drug)
结局指标
主要结局
All-cause mortality
时间窗: up to 28 days
Proportion of all-cause mortality
次要结局
- Duration of mechanical ventilation(up to 28 days)
- Length of stay in intensive care unit(up to 28 days)
- Body temperature (degree in Celsius)(Day 1, 3, 5, and 7 after administration of therapy)
- The Sequential Organ Failure Assessment (SOFA) Score(Day 1, 3, 5, and 7 after administration of therapy)
- PAO2/FIO2 ratio(Day 1, 3, 5, and 7 after administration of therapy)
- C-Reactive Protein (CRP) in mg/L(Day 1, 3, 5, and 7 after administration of therapy)
- D-Dimer in ng/mL(Day 1, 3, 5, and 7 after administration of therapy)
- Procalcitonin in ng/mL(Day 1, 3, 5, and 7 after administration of therapy)
- Interleukin 6 (IL-6) in pg/mL(Day 1, 3, 5, and 7 after administration of therapy)
- Allergic/ anaphylaxis transfusion reaction(24 hours post-transfusion)
- Hemolytic transfusion reaction(24 hours post-transfusion)
- Transfusion Related Acute Lung Injury(24 hours post-transfusion)
- Transfusion associated Circulatory Overload(24 hours post-transfusion)
研究者
Andri Maruli Tua Lubis
Head of Research Division RSCM
Indonesia University