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
About this trial
This is an interventional treatment trial for Severe Covid-19
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)
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
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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