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Immunoadsorpsjon ved autoimmun Long COVID (TURNLongCOVID)

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

En Placebokontrollert, Dobbelblind, Randomisert Studie Fase I-II med Immunadsorpsjon ved Autoimmun Langvarig 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

70

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Sham-komparator: 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.
Enhet: 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.
Aktiv komparator: 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.
Enhet: Immunoadsorption

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in fatigue measured by the Fatigue Assessment Scale (FAS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in health related quality of life using the 36-Item Short Form Health Survey (SF-36)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2026

Primær fullføring (Antatt)

12. desember 2027

Studiet fullført (Antatt)

12. mars 2028

Datoer for studieregistrering

Først innsendt

8. desember 2025

Først innsendt som oppfylte QC-kriteriene

18. desember 2025

Først lagt ut (Faktiske)

5. januar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NL-009359

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

IPD-planbeskrivelse

all request will be discussed within the study team

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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