Immunoadsorption in Autoimmune Long COVID (TURNLongCOVID)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase: Enrolling; Phase 2

Conditions: Long COVID Syndrome; Post COVID Syndrome; Long COVID; Long COVID-19 Syndrome

Treatments: Device: Immunoadsorption; Device: Sham Comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT07316127

NL-009359

Details and patient eligibility

About

Some people continue to have serious symptoms long after COVID-19, such as extreme fatigue and feeling worse after activity. In some patients, this may happen because the immune system is attacking the body by mistake.

This study will test a treatment called immunoadsorption, which filters the blood to remove harmful antibodies. People with long COVID who have these antibodies will be randomly assigned to receive either the real treatment or a placebo. The main goal is to see whether fatigue improves after one month, and whether other symptoms and daily functioning improve over six months.

This research will help us find out if this treatment can benefit the group of long COVID patients with immune-related disease.

Full description

Growing evidence indicates that autoantibodies may drive symptoms in a subset of people with long COVID, as demonstrated by symptom transfer to mice following administration of IgG from affected patients. This provides a strong rationale for targeted immunotherapy aimed at removing pathogenic antibodies. Immunoadsorption is a well-established method to reduce circulating IgG, but studies suggest that only a specific subgroup of patients benefits.

Using HuProt autoantibody microarray technology, we identified several autoantibodies uniquely present in long COVID patients compared with healthy controls. We subsequently developed and validated a disease-specific Luminex multiplex immunoassay to detect this autoimmune phenotype. This study will use these findings as a novel selection method of identifying long COVID patients with pathogenic IgG, thereby enriching the population most likely to benefit from immunoadsorption therapy.

This biomarker-guided personalized medicine approach could enhance treatment efficacy and advances long COVID therapeutic strategies. Additionally, the placebo-controlled and double blinded design will be needed to evaluate the true potential of autoantibodies adsorption therapy in long COVID. This study can add to our understanding on the role of autoantibodies in the pathogenesis of long COVID and could help in the development of precision-based immunotherapy for patients such as immunoadsorption.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Long COVID based on the WHO-criteria
• PEM according to the DSQ-PEM
• BELL's functionality score 20-70%
• Good health prior to the long COVID diagnosis (WHO performance score 0)

Exclusion criteria

• Medical history of clinically significant respiratory- or cardiovascular disease
• Prior interventional cardiac procedure within 3 months prior to randomization
• Active immunosuppresive treatment for systemic autoimmune disorders
• Diabetes type 1
• Solid organ malignancy in the last 5 years
• Active psychiatric disorder currently under treatment by a psychiatrist
• BMI > 35
• Pre-existing fatigue
• Poor performance score prior to the long COVID diagnosis (WHO performance >0)
• Pregnancy or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Placebo

Sham Comparator group

Description:

Participants in the placebo group will receive six sessions of sham treament, each lasting 2.5 hours over two weeks. The procedure will be performed without an adsorption column, allowing the blood to circulate through the extracorporeal circuit and be returned to the patient without removal of immunoglobulins or other plasma components.

Treatment:

Device: Sham Comparator

Immunoadsorption

Active Comparator group

Description:

Participants in the intervention group will receive six sessions of immunoadsorption, each lasting 2.5 hours over two weeks. Immunoadsorption will be performed using tryptophan columns, which bind the Fc region of IgG via hydrophobic and aromatic interactions.

Treatment:

Device: Immunoadsorption