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

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ClinicalTrials.gov Identifier: NCT04613986
Recruitment Status : Not yet recruiting
First Posted : November 3, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Severe Covid-19 Device: therapeutic plasmaexchnage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard
Standard of care according to our current in house SOP
Experimental: Treatment
Standard of care according to our current in house SOP + Therapeutic Plasmaexchange (d1, 3, 5)
Device: therapeutic plasmaexchnage
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)




Primary Outcome Measures :
  1. relative ADAMTS13 deficiency [ Time Frame: day 1 to 7 ]
    ADAMTS13 / VWF:Ag



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04613986    
Other Study ID Numbers: SD01
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders