临床试验/NCT04613986

NCT04613986Unknown不适用

Randomized, Prospective, Open-label, Controlled Parallel-group Trial Investigating the Efficacy of Therapeutic Plasma Exchange as an Adjunctive Strategy to Treat the Systemic Inflammatory Response Against SARS-CoV2 and the Associated Coagulopathy

University of Zurich0 个研究点目标入组 20 人开始时间: 2021年6月最近更新: 2021年4月29日

适应症

试验速览

阶段: 不适用
发起方: University of Zurich
入组人数: 20
主要终点: relative ADAMTS13 deficiency

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Randomized controlled trial to analyse adjuvant therapeutic plasma exchange (TPE) in severe Covid-19 associated coagulopathy and systemic inflammation compared to current standard of care (SOC).

A total of three TPEs (d1, 3, 5) will be performed in the intervention group. Primary endpoint is the reversibility of relative ADAMTS13 deficiency (indicated by the change in ADAMTS13 / VWF:Ag ratio from day 1 to 7).

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 (Participant)

入排标准

年龄范围: 18 Years 至 99 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Proven SARS-CoV2 infection
•Severe Covid-19 (indicated by respiratory failure requiring invasive mechanical ventilation)
•Evidence of coagulopathy (indicated by D-dimer > 10 mg/L)
•Evidence of systemic inflammation (CRP > 100 mg/L , ferritin > 500 ng/mL)

排除标准

•• Participation in another study with investigational drug within the 30 days preceding and during the present study,
•Previous enrolment into the current study.
•Extra corporeal membrane oxygenation (ECMO)

结局指标

主要结局

relative ADAMTS13 deficiency

时间窗: day 1 to 7

ADAMTS13 / VWF:Ag

次要结局

未报告次要终点

研究者

发起方

University of Zurich

申办方类型

Other

责任方

Sponsor

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