Immunoadsorption in Autoimmune Long COVID
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Immunoadsorption
DeviceImmunoadsorption will be performed using tryptophan columns, which bind the Fc region of IgG via hydrophobic and aromatic interactions.
Sham Comparator
DeviceThe 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: PlaceboSham comparator 1 intervention
Group B: ImmunoadsorptionActive comparator 1 intervention
Trial outcomes
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.
Time frame
At baseline and 28 days after start treatmentSecondary outcomes
1
Change in health related quality of life using the 36-Item Short Form Health Survey (SF-36)
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.
Time frame
At baseline and days 28, 60, 90, and 1802
Change in cognitive functioning using the Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function Short Form 8a (PROMIS Cognitive Function Short Form 8a)
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).
Time frame
At baseline and days 28, 60, 90, and 1803
Change in autonomic symptoms using the Composite Autonomic Symptom Score-31 (COMPASS-31)
0-100 weighted total score across six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor symptoms. Higher scores indicate greater autonomic symptom burden.
Time frame
At baseline and days 28, 60, 90, and 1804
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) related to the intervention
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)
Time frame
From first study intervention through day 180Sponsors and contacts
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Source ClinicalTrials.gov