Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
ID07316127

A Placebo-Controlled, Double-Blind, Randomized Trial with Immunoadsorption in Autoimmune Long COVID

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2026-01-05

70

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Some people with long COVID experience serious symptoms like extreme fatigue and worsening after activity, possibly due to the immune system mistakenly attacking the body. Researchers are investigating immunoadsorption, a treatment that filters the blood to remove harmful antibodies, to see if it can improve fatigue and other symptoms in those with an autoimmune form of long COVID. Participants will be randomly assigned to one of two groups. One group will receive six sessions of immunoadsorption using tryptophan columns over two weeks, which remove specific antibodies from the blood. The other group will receive a placebo treatment of six sham sessions, where blood circulates through the system without antibody removal, also lasting 2.5 hours each over two weeks. During the study, participants will be assessed for changes in fatigue, quality of life, cognitive function, autonomic symptoms, and physical strength at multiple time points up to six months. Researchers will also monitor immunoglobulin levels, autoantibody scores, and any adverse events to understand the treatment's effects and safety. The study includes a double-blind, placebo-controlled design to carefully evaluate immunoadsorption in long COVID patients with immune-related symptoms.

CONDITIONS

Brief Title

Immunoadsorption in Autoimmune Long COVID

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Long COVID based on the WHO-criteria
  • Post-exertional malaise according to the DSQ-PEM
  • BELL's functionality score between 20% and 70%
  • Good health before the long COVID diagnosis (WHO performance score 0)
  • Age between 18 and 65 years
Not Eligible

You will not qualify if you...

  • History of significant respiratory or cardiovascular disease
  • Interventional cardiac procedure within 3 months before randomization
  • Active immunosuppressive treatment for systemic autoimmune disorders
  • Type 1 diabetes
  • Solid organ cancer in the last 5 years
  • Active psychiatric disorder under current psychiatric treatment
  • Body mass index greater than 35
  • Fatigue existing before long COVID
  • Poor performance score before long COVID diagnosis (WHO performance score greater than 0)
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 2 weeks

Participants receive six sessions of either immunoadsorption or sham treatment over two weeks to remove or simulate removal of pathogenic antibodies.

6 sessions lasting 2.5 hours each

Follow-up

Duration - Up to 6 months after treatment

Participants are monitored for changes in fatigue, cognitive function, autonomic symptoms, quality of life, and antibody levels after treatment.

Visits at days 28, 60, 90, and 180 after treatment start

Trial Site Locations

Total: 1 location

1

AUMC

Amsterdam, Netherlands

Actively Recruiting

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Research Team

D

Daphne Schouten, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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