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Immunoadsorptie bij Auto-immuun Long COVID (TURNLongCOVID)

9 november 2026 bijgewerkt door: W. J. Wiersinga, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Een Placebo-Gecontroleerde, Dubbelblinde, Gerandomiseerde Studie Fase I-II Met Immunoadsorptie Bij Auto-immuun Long COVID

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

70

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Sham-vergelijker: Placebo

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.
Apparaat: 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.
Actieve vergelijker: Immunoadsorption

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.
Apparaat: Immunoadsorption

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in fatigue measured by the Fatigue Assessment Scale (FAS)
Tijdsspanne: At baseline and 28 days after start treatment

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in health related quality of life using the 36-Item Short Form Health Survey (SF-36)
Tijdsspanne: At baseline and days 28, 60, 90, and 180

Eight domains scored from 0-100. Domain scores are commonly summarized into the Physical Component Summary (PCS) and Mental Component Summary (MCS) (norm-based, mean 50, SD 10). Higher scores indicate better health-related quality of life and functioning.
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)
Tijdsspanne: At baseline and days 28, 60, 90, and 180

Raw scores are converted to T-scores (20-80), with a population mean of 50 (SD 10). Higher scores indicate better cognitive functioning. Change in score will be measured (MCID 3-5).
At baseline and days 28, 60, 90, and 180
Change in autonomic symptoms using the Composite Autonomic Symptom Score-31 (COMPASS-31)
Tijdsspanne: At baseline and days 28, 60, 90, and 180

0-100 weighted total score across six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor symptoms. Higher scores indicate greater autonomic symptom burden.
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
Tijdsspanne: From first study intervention through day 180

All AEs and SAEs will be recorded, graded according to CTCAE v5.0, and assessed for relatedness to the study treatment. Specific attention will be given to complications of extracorporeal procedures (e.g., hypotension, bleeding, allergic reactions, infection, and vascular access issues)
From first study intervention through day 180
Repeated Handgrip Strength
Tijdsspanne: At baseline and days 28, 60, 90, and 180

Handgrip strength will be assessed using a calibrated handheld dynamometer at four standardized measurement points in accordance with the American Society of Hand Therapists (ASHT) guidelines. Grip strength will be recorded in kilograms (kg). Higher grip strength reflects better muscle function.
At baseline and days 28, 60, 90, and 180
Orthostatic intolerance using the NASA lean test
Tijdsspanne: At baseline and days 28 and 180

The NASA Lean Test is a standardized active standing test used to assess orthostatic intolerance. Participants rest in a supine position followed by an active standing phase while leaning against a wall to minimize skeletal muscle pumping. Heart rate and blood pressure are measured at predefined intervals during standing. Abnormal heart rate and/or blood pressure responses during the test indicate orthostatic intolerance.
At baseline and days 28 and 180
Efficacy treatment by measuring immunoglobuline titers
Tijdsspanne: At baseline (prior to treatment initiation), during treatment, and at days 28 and 180 after treatment initiation.

Immunoglobulin G titers will be measured in blood samples using standardized laboratory assays and reported as concentrations (g/L).
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
Tijdsspanne: At screening and on days 28, 60, 90, and 180

For this assay, IgG will be isolated from patient serum samples obtained during screening and analyzed using a Luminex-based multiplex immunoassay targeting a panel of 15 validated autoantigens. A weighted scoring system is applied to the resulting autoantibody signals.
At screening and on days 28, 60, 90, and 180

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2026

Primaire voltooiing (Geschat)

12 december 2027

Studie voltooiing (Geschat)

12 maart 2028

Studieregistratiedata

Eerst ingediend

8 december 2025

Eerst ingediend dat voldeed aan de QC-criteria

18 december 2025

Eerst geplaatst (Werkelijk)

5 januari 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 november 2026

Laatste update ingediend die voldeed aan QC-criteria

9 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NL-009359

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

all request will be discussed within the study team

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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