Study Stopped
Low numbers of severe COVID-19 cases with current variants.
RescuE pLAsma eXchange in Severe COVID-19
RELAX
Sponsor study identifier
interventional
67
1 country
3
Study Start
January 7, 2020
Actual (reported)Primary Completion
April 30, 2023
Actual (reported)Study Completion
April 30, 2023
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 7, 2020
Actual (reported)December 23, 2020
Actual (reported)December 28, 2020
Actual (reported)April 30, 2023
Actual (reported)April 30, 2023
Actual (reported)Survival
Intention to treat analysis
30 days after randomization
Survival
15, 30, 60, 90, 365 days after randomization
Ventilator-free days
15, 30, 60, 90 days after randomization
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
Treatment with therapeutic plasma exchange. Plasma from healthy donors is used.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Heidelberg University Hospital
Heidelberg, Baden-Wurttemberg, 69120, Germany
Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg, 70174, Germany
University Hospital Essen
Essen, North Rhine-Westphalia, 45147, Germany
67 participants (actual enrollment reported by the registry).
First Submitted
December 23, 2020
First Posted
December 28, 2020
Study Start
January 7, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
April 30, 2023
Actual (reported)Study Completion
April 30, 2023
Actual (reported)Last Updated
April 15, 2025
Record last verified: 2025-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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