A Placebo-Controlled, Double-Blind, Randomized Trial Phase I-II With Immunoadsorption in Autoimmune Long COVID
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Netherlands
AUMC
RECRUITING
Amsterdam
Contact Information
Primary
Daphne Schouten, MD
postcovidtrials@amsterdamumc.nl
+31 20 566 9111
Time Frame
Start Date:2026-01-01
Estimated Completion Date:2028-03-12
Participants
Target number of participants:70
Treatments
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.