Therapeutic Plasma Exchange as an Adjunctive Strategy to Treat Coagulopathy and Inflammation in Severe Covid-19
Not Applicable
- Conditions
- Severe Covid-19
- Interventions
- Device: therapeutic plasmaexchnage
- Registration Number
- NCT04613986
- Lead Sponsor
- University of Zurich
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment therapeutic plasmaexchnage Standard of care according to our current in house SOP + Therapeutic Plasmaexchange (d1, 3, 5)
- Primary Outcome Measures
Name Time Method relative ADAMTS13 deficiency day 1 to 7 ADAMTS13 / VWF:Ag
- Secondary Outcome Measures
Name Time Method