A Randomised Controlled Trial of plasma exchange with standard of care compared to standard of care alone in the treatment of severe COVID-19 infection (COVIPLEX) - PEX in severe COVID-19

niversity College London0 个研究点目标入组 40 人开始时间: 2020年6月10日最近更新: 2020年7月27日

试验速览

暂无简介。

•Age 18-70
•Proven Covid-19/high clinical suspicion of Covid-19
•Hypoxia/respiratory compromise defined as requiring respiratory support of >2L/min of oxygen by nasal cannulae to maintain SpO2<96%.
•Raised inflammatory parameters: at least 2 of the following:
•a.Raised LDH (> 2 x ULN)
•b.Raised D Dimers (> 2X ULN)
•c.Raised CRP (>2X ULN)
•Females of childbearing potential have a negative pregnancy test within 7 days prior to being randomised. Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Significant co-morbid illness with treatment escalation limited to CPAP
•Active bleeding
•PF ratio < 100 on mechanical ventilation OR noradrenaline requirement > 0.5mcg/kg/min to maintain MAP > 65mmHg (suggests futility)
•Known allergies to Octaplas or excipients

发起方

niversity College London