NCT04685655

RescuE pLAsma eXchange in Severe COVID-19

RescuE pLAsma eXchange in Severe COVID-19 (RELAX Severe COVID-19)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Therapeutic Plasma Exchange
• Covid19

Interventions

Type	Name	Description
OTHER	Therapeutic plasma exchange	Treatment with therapeutic plasma exchange. Plasma from healthy donors is used.

Timeline

• Start date: 2020-01-07
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2020-12-28
• Last updated: 2025-04-15

Locations

3 sites across 1 country: Germany