Immunoadsorption blood filter for autoimmune long COVID
A Placebo-Controlled, Double-Blind, Randomized Trial Phase I-II With Immunoadsorption in Autoimmune Long COVID
We will test a blood-filter treatment called immunoadsorption in people with long COVID who have specific autoantibodies to see if their fatigue and daily functioning get better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT07316127 on ClinicalTrials.gov |
What this trial studies
Researchers will use a disease-specific autoantibody test to select long COVID patients with a likely autoimmune signature and then randomly assign them to receive immunoadsorption or a sham procedure in a double-blinded design. Immunoadsorption is a procedure that removes IgG antibodies from the blood and is already used in some autoimmune disorders. The main outcome is change in fatigue one month after treatment, with additional symptom and function assessments followed for six months. This biomarker-guided, placebo-controlled approach aims to concentrate on the subgroup most likely to benefit and to provide rigorous evidence of effect.
Who should consider this trial
Good fit: People with WHO-defined long COVID who experience post-exertional malaise, have moderate functional impairment (BELL score 20–70%), were in good health before COVID, and test positive on the study's disease-specific autoantibody assay are ideal candidates.
Not a fit: Patients without the autoantibody signature or with excluded conditions (recent major cardiac procedures, active systemic immunosuppression, diabetes type 1, recent cancer, BMI > 35, active treated psychiatric disorder, pre-existing fatigue, poor pre-COVID performance, pregnancy or breastfeeding) are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could reduce fatigue and improve daily functioning for the subgroup of long COVID patients who have pathogenic autoantibodies.
How similar studies have performed: Immunoadsorption has shown benefit in some autoimmune conditions and case series suggest possible effect in selected long COVID patients, but randomized biomarker-guided trials like this are novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amsterdam
- Aumc — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Daphne Schouten, MD
- Email: postcovidtrials@amsterdamumc.nl
- Phone: +31 20 566 9111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.