Official Title
A Placebo-Controlled, Double-Blind, Randomized Trial Phase I-II With Immunoadsorption in Autoimmune Long COVID
Brief Summary

Some people continue to have serious symptoms long after COVID-19, such as extremefatigue and feeling worse after activity. In some patients, this may happen because theimmune system is attacking the body by mistake.This study will test a treatment called immunoadsorption, which filters the blood toremove harmful antibodies. People with long COVID who have these antibodies will berandomly assigned to receive either the real treatment or a placebo. The main goal is tosee whether fatigue improves after one month, and whether other symptoms and dailyfunctioning improve over six months.This research will help us find out if this treatment can benefit the group of long COVIDpatients 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.

Recruiting
Long Covid
Long COVID Syndrome
Long COVID-19 Syndrome
Post COVID Syndrome

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.

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
Netherlands
Locations

AUMC
Amsterdam, Netherlands

Investigator: Daphne Schouten, MD
Contact: +31 20 566 9111
postcovidtrials@amsterdamumc.nl

Contacts

Daphne Schouten, MD
+31 20 566 9111
postcovidtrials@amsterdamumc.nl

Not Provided

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
NCT Number
Keywords
Immunoadsorption
long COVID
Post COVID
plasmapheresis
MeSH Terms
Post-Acute COVID-19 Syndrome
Plasmapheresis