NCT05841498Completed
Immunoadsorption Study Mainz in Adults With Post-COVID Syndrome
A Single-blinded Sham-controlled Crossover Trial to Evaluate the Effect of Immunoadsorption on Post-Corona Virus Disease (COVID)-Syndrome
Source: ClinicalTrials.gov · Last updated 28 Jul 2025
Brief summary (registry, in English)
The aim of this study is to evaluate the efficiency and safety of immunoadsorption for the treatment of post-COVID syndrome (PCS). Efficacy will be measured (1) subjectively as an improvement of the score of questionnaires like the multidimensional fatigue inventory (MFI-20), Chalder fatigue scale, Bell-score, modified medical research council dyspnea scale (mMRC) and the Post-COVID functional scale (PCFS) and (2) objectively as an improvement in neurocognitive testing with the Montreal cognitive assessment (MoCA) and the improvement of the hand-grip strength. 40 participants with symptoms of PCS and a PCFS score of at least 2 will be included in each group (Addendum from February 2024: An additional 40 patients with the same inclusion and exclusion criteria will be treated using the devices and materials of another manufacturer, following the same design, and the results will be evaluated separately.). After excluding other causes of the symptoms and evaluating the baseline burden of symptoms, each participant will undergo 5 sessions of immunoadsorption with an immunoglobulin-binding adsorber and 5 sham treatments, or vice versa. The order of treatments (immunoadsorption first or sham first) will be randomized. Each participant will be blinded to the type of treatment they receive. An 8-week therapy-free period will separate the two treatment blocks. All examinations will be conducted before the first treatment, 2 weeks after the first treatment cycle, before the second treatment cycle, and 2 and 6 weeks after the second treatment cycle. The results of the study will inform future treatment strategies for PCS and will contribute to a better understanding of the pathophysiological insights behind the ongoing symptoms.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 25 Apr 2023
- Start date
- 8 May 2023
- Primary completion date
- 12 May 2025
- Lead sponsor
- University Medical Center Mainz
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05841498
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 8 May 2023 to the primary completion date, 12 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intake of ACE-inhibitors 7 days prior to the inclusion in to the study or during the study period
Other illness
- Psychiatric diagnosis
- Allergy to adsorber materials, materials of the tubing systems or to the substances used for immunoadsorption
- Medical contraindications to immunoadsorption such as severe blood clotting disorders or immunodeficiency syndromes
- Existing antibody-mediated autoimmune disease
Other
- Pregnancy
Who the study is looking for
- Meeting the WHO diagnostic criteria for PCS
- Written informed consent to participate in the study
- Previous participation in the Gutenberg Post-Covid Study or previously conducted comparable preliminary examinations
- Minimum age of 18 years
- Value on the Post-COVID functional scale of at least 2
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
Related publications
- Immunoadsorption Versus Sham Treatment for Post-COVID Syndrome: A Randomised Sham-Controlled Crossover Trial.Lancet Reg Health Eur · 2026 · PMID 42318167
This page is information, not medical advice. Discuss any trial with your doctor.