Immunoadsorption in Autoimmune Long COVID

NCT07316127 | Recruiting Phase 2 DMC

• 1 other identifier: NL-009359
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Long COVID; Long COVID Syndrome; Long COVID-19 Syndrome; Post COVID Syndrome

Keywords

immunoadsorption; long COVID; post COVID; plasmapheresis

Outcome Measures

Primary Outcomes (1)

• Change in fatigue measured by the Fatigue Assessment Scale (FAS)

  Score range 10-50 (10 items, Likert scale 1-5). Higher scores indicate more severe fatigue (worse). The difference in scores from baseline will be measured (MCID of 4 points) as the primary outcome.

  At baseline and 28 days after start treatment

Secondary Outcomes (8)

• Change in health related quality of life using the 36-Item Short Form Health Survey (SF-36)

  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)

  At baseline and days 28, 60, 90, and 180

• Change in autonomic symptoms using the Composite Autonomic Symptom Score-31 (COMPASS-31)

  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

  From first study intervention through day 180

• Repeated Handgrip Strength

  At baseline and days 28, 60, 90, and 180

Study Arms (2)

Placebo

SHAM COMPARATOR

Participants in the placebo group will receive six sessions of sham treament, each lasting 2.5 hours over two weeks. The procedure will be performed without an adsorption column, allowing the blood to circulate through the extracorporeal circuit and be returned to the patient without removal of immunoglobulins or other plasma components.

Device: Sham Comparator

Immunoadsorption

ACTIVE COMPARATOR

Participants in the intervention group will receive six sessions of immunoadsorption, each lasting 2.5 hours over two weeks. Immunoadsorption will be performed using tryptophan columns, which bind the Fc region of IgG via hydrophobic and aromatic interactions.

Device: Immunoadsorption

Interventions

Immunoadsorption DEVICE

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

Immunoadsorption

Sham Comparator DEVICE

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

AUMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Plasmapheresis

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Central Study Contacts

Daphne Schouten, MD

CONTACT

+31 20 566 9111; postcovidtrials@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 12, 2027
• Study Completion (Estimated): March 12, 2028
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

NL (1)