Immunoadsorption Study Mainz in Adults With Post-COVID Syndrome

Summary

The aim of this study is to evaluate the efficiency and safety of immunoadsorption for the treatment of post-COVID syndrome (PCS).

Efficacy will be measured (1) subjectively as an improvement of the score of questionnaires like the multidimensional fatigue inventory (MFI-20), Chalder fatigue scale, Bell-score, modified medical research council dyspnea scale (mMRC) and the Post-COVID functional scale (PCFS) and (2) objectively as an improvement in neurocognitive testing with the Montreal cognitive assessment (MoCA) and the improvement of the hand-grip strength.

40 participants with symptoms of PCS and a PCFS score of at least 2 will be included in each group (Addendum from February 2024: An additional 40 patients with the same inclusion and exclusion criteria will be treated using the devices and materials of another manufacturer, following the same design, and the results will be evaluated separately.). After excluding other causes of the symptoms and evaluating the baseline burden of symptoms, each participant will undergo 5 sessions of immunoadsorption with an immunoglobulin-binding adsorber and 5 sham treatments, or vice versa. The order of treatments (immunoadsorption first or sham first) will be randomized. Each participant will be blinded to the type of treatment they receive. An 8-week therapy-free period will separate the two treatment blocks. All examinations will be conducted before the first treatment, 2 weeks after the first treatment cycle, before the second treatment cycle, and 2 and 6 weeks after the second treatment cycle.

The results of the study will inform future treatment strategies for PCS and will contribute to a better understanding of the pathophysiological insights behind the ongoing symptoms.

Conditions

• Post-COVID-19 Syndrome
• Post-COVID Syndrome
• Post COVID-19 Condition

Interventions

DEVICE

Immunoadsorption

Immunoadsorption (IA) is a well-established extracorporeal therapy for several autoimmune diseases such as systemic lupus. Its therapeutic effect is based on the removal of antibodies (ABs) from the plasma including auto-ABs and it is used if an immediate response to therapy is necessary. Side effects (SE) of the IA are rare, but angiotensin-converting enzyme (ACE)-inhibitors are prohibited concomitant medication. Notable SE may include increased susceptibility to infection, transient disorders of blood coagulation, or allergic reactions to materials of the adsorber or tubing system. To ensure an effective therapy, a blood flow of at least 45 ml/min is necessary. In some patients, adequate blood flow can be achieved by cannulation of peripheral veins but in most patients is the placement of a central venous catheter necessary. Central venous catheter placement carries potential risks such as injury to the lung or mispuncture of the carotid artery.

DEVICE

Sham-apheresis

Sham-apheresis is a procedure without any known therapeutic effects. As there are no known therapeutic effects there are also no known side effects excepted the risk of an allergic reaction to materials of the tubing system or to citrate, which is necessary to prevent clotting inside the extracorporeal system. To ensure a smooth operation a blood-flow of at least 45ml/min is necessary. In some patients, adequate blood flow can be achieved by cannulation of peripheral veins. However, in most patients, placement of a Shaldon catheter into the internal jugular vein is necessary. Shaldon catheter placement carries other potential risks such as injury to the lung resulting in pneumothorax or mispuncture of the carotid artery. However, since the catheter placement is sonography-guided, the risks for such adverse events are minimized.

Sponsors & Collaborators

• University Medical Center Mainz

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-08

Primary Completion

2025-05-12

Completion

2025-05-12

Countries

• Germany

Study Locations