RescuE pLAsma eXchange in Severe COVID-19

NCT04685655 | Terminated DMC

• 1 other identifier: S-911/2020
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Plasma exchange; Covid19

Outcome Measures

Primary Outcomes (1)

• Survival

  Intention to treat analysis

  30 days after randomization

Secondary Outcomes (9)

• 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

Study Arms (2)

COVID-19 therapy according to center standard alone

NO INTERVENTION

Therapeutic plasma exchange and COVID-19 therapy according to center standard

ACTIVE COMPARATOR

Other: Therapeutic plasma exchange

Interventions

Therapeutic plasma exchange OTHER

Treatment with therapeutic plasma exchange. Plasma from healthy donors is used.

Therapeutic plasma exchange and COVID-19 therapy according to center standard

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (3)

Heidelberg University Hospital

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, 70174, Germany

Location

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

MeSH Terms

Conditions

COVID-19

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Attending, Department of Nephrology

Model Details: Therapeutic plasma exchange in patients with severe COVID 19

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 28, 2020
• Study Start: January 7, 2020
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

DE (3)