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

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

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).

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)