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
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).

Status
Unknown status
Conditions
Severe Covid-19
Interventions

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)

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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 99 Years
Sponsors / Collaborators
University of Zurich
NCT Number
NCT04613986
MeSH Terms
COVID-19