RescuE pLAsma eXchange in Severe COVID-19

Covid19 Clinical Trial

— RELAX  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04685655
• Other study ID #: S-911/2020
• Status: Terminated
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: April 30, 2023

Study information

• Verified date: November 2023
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Therapeutic Plasma Exchange

Intervention

Other:
• Therapeutic plasma exchange
Treatment with therapeutic plasma exchange. Plasma from healthy donors is used.

Locations

Country	Name	City	State
Germany	University Hospital Essen	Essen	Nordrhein-Westfalen
Germany	Heidelberg University Hospital	Heidelberg	Baden-Württemberg
Germany	Klinikum Stuttgart	Stuttgart	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

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