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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04613986
Recruitment Status : Not yet recruiting
First Posted : November 3, 2020
Last Update Posted : November 3, 2020
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

Information from the National Library of Medicine

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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

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 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