RescuE pLAsma eXchange in Severe COVID-19 (RELAX)

Heidelberg University

Status: Terminated

Conditions: Therapeutic Plasma Exchange; Covid19

Treatments: Other: Therapeutic plasma exchange

Study type: Interventional

Funder types: Other

Identifiers

NCT04685655

S-911/2020

Details and patient eligibility

About

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).

Enrollment: 67 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

COVID-19 therapy according to center standard alone

No Intervention group

Therapeutic plasma exchange and COVID-19 therapy according to center standard

Active Comparator group

Treatment:

Other: Therapeutic plasma exchange