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

Severe Covid-19 Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04613986
• Other study ID #: SD01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2021
• Est. completion date: July 2022

Study information

• Verified date: April 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemostatic Disorders
• Severe Covid-19

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relative ADAMTS13 deficiency	ADAMTS13 / VWF:Ag	day 1 to 7