Immunoadsorption in Autoimmune Long COVID
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immunoadsorption, Sham Comparator.
- Who it may be relevant to
- Registry conditions: Long COVID, Long COVID Syndrome, Long COVID-19 Syndrome, Post COVID Syndrome. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Placebo-Controlled, Double-Blind, Randomized Trial Phase I-II With Immunoadsorption in Autoimmune Long COVID
Overview
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.
Detailed 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.
Interventions
- Device Immunoadsorption
Immunoadsorption will be performed using tryptophan columns, which bind the Fc region of IgG via hydrophobic and aromatic interactions. - Device Sham Comparator
The immunoadsorption column will be removed from the device, so that the patient's blood passes through the system and is returned to the body without undergoing adsorption or removal of antibodies.
Primary outcome measures
- Change in fatigue measured by the Fatigue Assessment Scale (FAS) [Time frame: At baseline and 28 days after start treatment]
Secondary outcome measures (8)
- Change in health related quality of life using the 36-Item Short Form Health Survey (SF-36) [Time frame: At baseline and days 28, 60, 90, and 180]
- Change in cognitive functioning using the Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function Short Form 8a (PROMIS Cognitive Function Short Form 8a) [Time frame: At baseline and days 28, 60, 90, and 180]
- Change in autonomic symptoms using the Composite Autonomic Symptom Score-31 (COMPASS-31) [Time frame: At baseline and days 28, 60, 90, and 180]
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) related to the intervention [Time frame: From first study intervention through day 180]
- Repeated Handgrip Strength [Time frame: At baseline and days 28, 60, 90, and 180]
- Orthostatic intolerance using the NASA lean test [Time frame: At baseline and days 28 and 180]
- Efficacy treatment by measuring immunoglobuline titers [Time frame: At baseline (prior to treatment initiation), during treatment, and at days 28 and 180 after treatment initiation.]
- Autoantibody score using an in-house Luminex assay [Time frame: At screening and on days 28, 60, 90, and 180]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- AUMC — Amsterdam
Identifiers
NCT: NCT07316127 · NL-009359