Covid19 Clinical Trial
— RELAXOfficial title:
RescuE pLAsma eXchange in Severe COVID-19 (RELAX Severe COVID-19)
Verified date | November 2023 |
Source | Heidelberg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 67 |
Est. completion date | April 30, 2023 |
Est. primary completion date | April 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Essen | Essen | Nordrhein-Westfalen |
Germany | Heidelberg University Hospital | Heidelberg | Baden-Württemberg |
Germany | Klinikum Stuttgart | Stuttgart | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
Heidelberg University |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival | Intention to treat analysis | 30 days after randomization | |
Secondary | Survival | Intention to treat & per protocol | 15, 30, 60, 90, 365 days after randomization | |
Secondary | Ventilator-free days | 15, 30, 60, 90 days after randomization | ||
Secondary | Length of hospital an ICU stay | through study completion, an average of 1 year | ||
Secondary | Improvement defined as two points on seven point ordinal WHO scale | through study completion, an average of 1 year | ||
Secondary | Reduction of vasopressors after TPE treatments | through study completion, an average of 1 year | ||
Secondary | Incidence of acute kidney injury, renal replacement therapy and renal recovery | AKI KDIGO criteria | 15, 30, 60, 90 days after randomization | |
Secondary | Frequency of typical complications associated to therapeutic plasma exchange | through study completion, an average of 1 year | ||
Secondary | Reduction of inflammation mediators, (auto-)antibodies, and coagulation-associated molecules and their temporal correlation to TPE | through study completion, an average of 1 year | ||
Secondary | D-dimer-dependent assessment of therapeutic efficacy. | through study completion, an average of 1 year |
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