Immunoadsorption in Autoimmune Long COVID

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study ID
NCT07316127
Phase
PHASE2
Status
Recruiting
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Conditions

  • Long COVID
  • Long COVID Syndrome
  • Long COVID-19 Syndrome
  • Post COVID Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jan 5, 2026
Start date
Jan 1, 2026
Status verified
Dec 2025
Primary completion
Dec 12, 2027
Completion
Mar 12, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Change in fatigue measured by the Fatigue Assessment Scale (FAS) [ Time Frame: At baseline and 28 days after start treatment ]

Central Contacts

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