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

Primary Purpose

Severe Covid-19

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
therapeutic plasmaexchnage
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Covid-19

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard

    Treatment

    Arm Description

    Standard of care according to our current in house SOP

    Standard of care according to our current in house SOP + Therapeutic Plasmaexchange (d1, 3, 5)

    Outcomes

    Primary Outcome Measures

    relative ADAMTS13 deficiency
    ADAMTS13 / VWF:Ag

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 2020
    Last Updated
    April 27, 2021
    Sponsor
    University of Zurich
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04613986
    Brief Title
    Therapeutic Plasma Exchange as an Adjunctive Strategy to Treat Coagulopathy and Inflammation in Severe Covid-19
    Acronym
    PExCoV
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2021 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    July 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Zurich

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severe Covid-19

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard
    Arm Type
    No Intervention
    Arm Description
    Standard of care according to our current in house SOP
    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    Standard of care according to our current in house SOP + Therapeutic Plasmaexchange (d1, 3, 5)
    Intervention Type
    Device
    Intervention Name(s)
    therapeutic plasmaexchnage
    Intervention Description
    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 Measure Information:
    Title
    relative ADAMTS13 deficiency
    Description
    ADAMTS13 / VWF:Ag
    Time Frame
    day 1 to 7

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)

    12. IPD Sharing Statement

    Learn more about this trial

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

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