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

University of Zurich (UZH)

Status: Unknown

Conditions: Severe Covid-19

Treatments: Device: therapeutic plasmaexchnage

Study type: Interventional

Funder types: Other

Identifiers

NCT04613986

SD01

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Standard

No Intervention group

Description:

Standard of care according to our current in house SOP

Treatment

Experimental group

Description:

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

Treatment:

Device: therapeutic plasmaexchnage