Therapeutic Plasma Exchange for Coronavirus Disease-2019 Triggered Cytokine Release Storm; a Retrospective Propensity Matched Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UNICEF
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Survival
研究概览
简要总结
Background:
investigators have seen recently from experience in Western countries with best health care systems that pandemics cannot be managed in hospitals. Investigators have seen ICUs crowded to capacity, healthcare workers being exposed and going to quarantine or dying after exposure to large doses of viral inoculums. Investigators recommend that institutions should register for Clinical trials and consider emergency use of TPE. In Pandemics, time is of essence to avoid mortality by intervening early with available evidence, preferably as part of clinical trial.
Scientific rationale:
Beyond supportive care, there are currently no proven treatment options for coronavirus disease (COVID-19) and related pneumonia, caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). However, literature review has shown that most common cause of death in severe SARS-COV-2 is Cytokine release syndrome and Hemophygocytic Lymphohistocytosis (HLH). In this context, Investigators seek to treat patients who are sick enough to warrant hospitalization prior to the onset of overwhelming disease including a systemic inflammatory response, sepsis, and/or Acute Respiratory Distress Syndrome (ARDS).
详细描述
PROTOCOL SUMMARY:
Therapeutic plasma exchange for coronavirus disease-2019 triggered cytokine release storm; a retrospective propensity matched control study
Clinical Phase: Two arms, Phase 2 Open Label
Conducted by: Department of Pulmonology and Critical Care; Pak Emirates Military Hospital.
Sample Size: 280
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID-19 diagnosed by Polymerase Chain Reaction (PCR) positivity for SARS-CoV2
- •CRS at presentation or developing during hospitalization
- •10-80 years age and both genders
- •hospital admission
- •At least 1 completed session of plasma-exchange in patients included in TPE arm
- •No other novel therapy administered.
- •Exclusion criteria were:
- •Death within 48 hours of admission
- •severe septic shock at time of admission
- •Congestive cardiac failure (EF<20%) (4)
- •Those receiving immunotherapy, Anti-thymocyte globulin or hematopoietic stem cell transplant in recent past
- •Patients of hematological or solid organ malignancies
- •patients receiving other investigational drugs including Tocilizumab, Convalescent plasma, Remdesivir, or Mesenchymal stem cells.
排除标准
- 未提供
结局指标
主要结局
Survival
时间窗: 28 days
Death or recovery
次要结局
- Timing of PCR negativity(28 days)
- Duration of Hospitalization(28 days)
- Time to CRS resolution(28 days)
- Complications(28 days)
研究者
sultan mehmood kamran
Classified Medical specialist
UNICEF
