RescuE pLAsma eXchange in Severe COVID-19

NCT ID: NCT04685655

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-07
• Study Completion Date: 2023-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

COVID-19 therapy according to center standard alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: ACTIVE_COMPARATOR

Therapeutic plasma exchange

Intervention Type: OTHER

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

Interventions

Therapeutic plasma exchange

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Christian Nusshag

MD, Attending, Department of Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Heidelberg University Hospital

Heidelberg, Baden-Wurttemberg, Germany

Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, Germany

University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

S-911/2020

Identifier Type: -

Identifier Source: org_study_id