Official Title
RescuE pLAsma eXchange in Severe COVID-19 (RELAX Severe COVID-19)
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).

Recruiting
Therapeutic Plasma Exchange
COVID19

Other: Therapeutic plasma exchange

Treatment with therapeutic plasma exchange. Plasma from healthy donors is used.

Eligibility Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 85 Years
Countries
Germany
Locations

Heidelberg University Hospital
Heidelberg, Baden-Württemberg, Germany

Klinikum Stuttgart
Stuttgart, Baden-Württemberg, Germany

University Hospital Essen
Essen, Nordrhein-Westfalen, Germany

Contacts

Christian Nusshag, MD
+496221-5634952
Christian.Nusshag@med.uni-heidelberg.de

Heidelberg University
NCT Number
Keywords
Plasma exchange
COVID19
MeSH Terms
COVID-19