long-COVID or post-COVID long-COVID or post-COVID
Conditions
Interventions
Six sessions of immunoadsorption of 2,5 hours each spread over two weeks or placebo. 
Immunoadsorption will be done using tryptophan immunoadsorption (DIAMED). In the placebo group, the immunoadsorption filter will be removed and blood will pass through the machine without adsorption.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients aged 18 to 65 with an autoimmune long COVID phenotype, based on the WHO criteria and positive screening test for autoantibodies, and experiencing post-exertional malaise (PEM) according to the DSQ-PEM. Patients must have been in good health before developing Long COVID (WHO performance status 0) and have a current Bell’s functionality score ranging from 20-75%.
Exclusion criteria
Exclusion criteria: xclusion criteria include a medical history of clinically significant respiratory- or cardiovascular disease or prior interventional cardiac procedure (e.g., cardiac catheterization) within 3 months prior to randomization, immunosuppressive treatment for autoimmune disorders (e.g. rheumatoid arthritis or ulcerative colitis), diabetes type 1, a solid organ malignancy in the last 5 years, active psychiatric disorder currently under treatment by a psychiatrist, active human immunodeficiency virus (HIV), BMI>35, pre-existing fatigue, pregnancy or breastfeeding. Prohibited medication includes the use of immunosuppressants, anticoagulants, angiotensin-converting enzyme (ACE)-inhibitors or concurrent treatment with an investigational product. Meaningful laboratory abnormalities, such as renal insufficiency (eGFR (CKD-epi) <60 ml/min/1,73m2) , will also be excluded. Inadequate venous diameter for central venous catheter (CVC) placement, defined as a vein-to-catheter diameter ratio < 3:1, will also be excluded. Due to the number of visits, patients who are bedbound (Bell’s functionality score <20%) will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is improvement of fatigue as measured with the Fatigue Assessment Scale (FAS) on day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include immunoglobulin titers measured on baseline, during treatment, day 28 and 180; improvement in various disease domains within long COVID on days 28, 60, 90 and 180 using the SF-36, the EQ-5D-5L, the COMPASS-31, the PROMIS cognitive function 8a, the DSQ-PEM and the Bell’s score; biological improvement on day 28, 60, 90 and day 180 using a novel screening assay. In addition, physical improvement will be measured using the Repeated Handgrip Strength on baseline an day 28, 60, 90 and 180, the NASA-lean test and the Amsterdam Cognition Scan on baseline, day 28 and day 180. | — |
Countries
Netherlands
Contacts
Public ContactD Schouten
Amsterdam UMC
Outcome results
None listed