RescuE pLAsma eXchange in Severe COVID-19
- Conditions
- Therapeutic Plasma ExchangeCovid19
- Interventions
- Other: Therapeutic plasma exchange
- Registration Number
- NCT04685655
- Lead Sponsor
- Heidelberg University
- Brief Summary
The spectrum of coronavirus disease 2019 (COVID-19) ranges from asymptomatic infection to acute respiratory distress syndrome ("ARDS") and patient death. Severely affected patients may develop a cytokine storm-like clinical syndrome with high mortality. Laboratory tests in these patients show an excessive and uncontrolled immune response with consecutive multi-organ failure. In addition, there is evidence for the development of prothrombotic autoantibodies as an epiphenomenon of "Severe Acute Respiratory Syndrome Coronavirus 2" (SARS-CoV-2) infection. Therapeutic plasma exchange ("TPE") is being discussed as a therapeutic alternative in patients with severe, refractory COVID-19. The idea is that plasma exchange eliminates both endogenous and exogenous inducers of an exuberant inflammatory response as well as prothrombotic factors, thus breaking the secondary vicious circle of SARS-CoV-2 infection. In general, TPE is a safe procedure with known efficacy in other severe viral diseases as well as in cytokine storm-like diseases and ARDS of other geneses. Moreover, initial data, mostly derived from case studies, demonstrate promising therapeutic efficacy of TPE in severe COVID-19 courses with previously lacking treatment options. To further evaluate the therapeutic efficacy of TPE in severe COVID-19, a prospective randomized controlled trial of TPE in severe SARS-CoV-2 infection is being conducted at our center. Patients will be randomized to a control group (standard therapy according to center standards) and a therapy/intervention group (standard therapy + TPE).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 67
- Written informed consent by the study participant or their legally appointed representative.
- Age ≥ 18 years
- Evidence of acute SARS-CoV-2 infection, confirmed by PCR testing
- Invasive ventilation
- Fever ≥ 38.5°C, confirmed by a total of 3 consecutive measurements or ongoing renal replacement therapy and temperature ≥ 37.5°C
- D-dimers ≥ 2mg/L
- Dexamethasone ≥ 6mg/day or equivalent dose on at least 2 days
- Age > 85 years
- Pre-existing treatment limitations
- Pregnancy
- Confirmed pulmonary arterial embolism with hemodynamically relevant right heart strain
- ST-segment elevation myocardial infarction (STEMI)
- Participation in an intervention study elsewhere
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Therapeutic plasma exchange and COVID-19 therapy according to center standard Therapeutic plasma exchange -
- Primary Outcome Measures
Name Time Method Survival 30 days after randomization Intention to treat analysis
- Secondary Outcome Measures
Name Time Method Ventilator-free days 15, 30, 60, 90 days after randomization Frequency of typical complications associated to therapeutic plasma exchange through study completion, an average of 1 year Survival 15, 30, 60, 90, 365 days after randomization Intention to treat \& per protocol
Length of hospital an ICU stay through study completion, an average of 1 year Improvement defined as two points on seven point ordinal WHO scale through study completion, an average of 1 year Reduction of vasopressors after TPE treatments through study completion, an average of 1 year Incidence of acute kidney injury, renal replacement therapy and renal recovery 15, 30, 60, 90 days after randomization AKI KDIGO criteria
Reduction of inflammation mediators, (auto-)antibodies, and coagulation-associated molecules and their temporal correlation to TPE through study completion, an average of 1 year D-dimer-dependent assessment of therapeutic efficacy. through study completion, an average of 1 year
Trial Locations
- Locations (3)
Klinikum Stuttgart
🇩🇪Stuttgart, Baden-Württemberg, Germany
University Hospital Essen
🇩🇪Essen, Nordrhein-Westfalen, Germany
Heidelberg University Hospital
🇩🇪Heidelberg, Baden-Württemberg, Germany