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临床试验/NCT04485169
NCT04485169已完成不适用

Therapeutic Plasma Exchange for Coronavirus Disease-2019 Triggered Cytokine Release Storm; a Retrospective Propensity Matched Control Study

UNICEF2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2020年4月1日最近更新:
适应症

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

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

发起方
UNICEF
申办方类型
Other
责任方
Principal Investigator
主要研究者

sultan mehmood kamran

Classified Medical specialist

UNICEF

研究点 (2)

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