NCT04685655: RELAX

RescuE pLAsma eXchange in Severe COVID-19

Terminated NA Last updated 15 April 2025

What this trial tests

NA trial testing Therapeutic plasma exchange in Therapeutic Plasma Exchange in 67 participants. Terminated before completion.

Timeline

7 January 2020

Primary endpoint
30 April 2023

30 April 2023

Quick facts

Lead sponsor	Heidelberg University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	67
Start date	7 January 2020
Primary completion	30 April 2023
Estimated completion	30 April 2023
Sites	3 locations across Germany

Drugs / interventions tested

• Therapeutic plasma exchange — full drug profile →

Conditions studied

• Therapeutic Plasma Exchange — all drugs for Therapeutic Plasma Exchange →
• Covid19 — all drugs for Covid19 →

Sponsor

Heidelberg University

Who can join

Adults 18 to 85, any sex, with Therapeutic Plasma Exchange or Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Research priorities for therapeutic plasma exchange in critically ill patients.
   David S, Russell L, Castro P, van de Louw A, et al · · 2023 · cited 18× · PMID 37150798 · DOI 10.1186/s40635-023-00510-w
2. Plasma Exchange in Patients With Severe Coronavirus Disease 2019: A Single-Center Experience.
   Nusshag C, Morath C, Speer C, Kaelble F, et al · · 2021 · cited 9× · PMID 34476404 · DOI 10.1097/cce.0000000000000517