RecruitingPhase 2NCT07316127

Immunoadsorption in Autoimmune Long COVID

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

Sponsor

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

Enrollment

70 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Long COVID-19 Syndrome Long COVID Long COVID Syndrome

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

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 Criteria10

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

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Interventions

DEVICEImmunoadsorption

Immunoadsorption will be performed using tryptophan columns, which bind the Fc region of IgG via hydrophobic and aromatic interactions.

DEVICESham 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.