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

Sponsor

University of Zurich (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04613986

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Severe Covid-19	Device: therapeutic plasmaexchnage	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

relative ADAMTS13 deficiency [day 1 to 7]
ADAMTS13 / VWF:Ag

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Zurich

ClinicalTrials.gov Identifier:

NCT04613986

Other Study ID Numbers:

SD01

First Posted:

Nov 3, 2020

Last Update Posted:

Apr 29, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Apr 29, 2021