Therapeutic Plasma Exchange as an Adjunctive Strategy to Treat Coagulopathy and Inflammation in Severe Covid-19

University of Zurich20 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Severe Covid-19

Interventions

therapeutic plasmaexchnageDEVICE

established method to exchange plasma (in order to remove injurious disease mediators, e.g. antibodies) or to replace consumed factors (e.g. vWF cleaving proteases)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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) Exclusion Criteria: * • 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)

Outcomes

Primary Outcomes

relative ADAMTS13 deficiency

ADAMTS13 / VWF:Ag

Time frame: day 1 to 7

Data from ClinicalTrials.gov

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