Stortz Marco, Klimpke Pascal, Kommer Andreas, Gründer Philipp, Steenken Livia, Dresel Christian, Kraus Daniel, Schmidtmann Irene, Weinmann Arndt, Weinmann-Menke Julia
Department for Nephrology, Rheumatology and Kidney Transplantation, I. Unit for Internal Medicine, University Medical Center of the Johannes Gutenberg-University Mainz, Langenbeckstr. 1, Mainz, Germany.
Department for Neurology, University Medical Centerof the, Johannes Gutenberg-University Mainzaq , Langenbeckstr. 1, Mainz, Germany.
Trials. 2025 Apr 3;26(1):119. doi: 10.1186/s13063-025-08825-7.
Post-COVID syndrome (PCS) affects up to 43% of all SARS-CoV-2-infected persons and describes ongoing symptoms months after the acute infection. Despite the large number of affected people, there is still very little evidence about therapeutic options. Some studies suggest at least partially a role of autoantibody-mediated autoimmunity. Immunoadsorption is an extracorporeal therapy to remove circulating antibodies which is used successfully in several autoimmune diseases. We conceived the IAMPOCO trial to evaluate the therapeutic effect of immunoadsorption in patients with PCS.
IAMPOCO is a single-center randomized sham-controlled trial with a crossover design which will enroll 40 participants with PCS and a symptom severity of at least 2 on post-COVID functional scale. All participants will undergo 5 immunoadsorption treatments and after a washout period of 8 weeks 5 sham treatments or vice versa. Which modality is conducted first will be randomized. Patients but not providers of therapy are blinded for which modality is conducted. Primary outcome is the efficacy of IA to the severity of PCS measured by the change of several symptom scores and hand grip strength. Secondary outcomes are the frequency of adverse events and the prevalence of relevant autoantibodies in participants with PCS as well as the concentration of autoantibodies before and after therapy and sham treatment.
The trial addresses the lack of evidence for treatment options in PCS. By using a crossover design and including a sham treatment arm, the study aims to compare the effects of immunoadsorption and sham therapy within the same patients. The trial also benefits from recruiting participants from a cohort study on PCS prevalence, ensuring a thorough evaluation of symptoms. Objective assessments of symptoms are challenging due to their subjective nature, but various scoring systems and tests are being utilized. Despite the lack of data from RCTs, the results of this study have the potential to significantly improve PCS therapy and support evidence-based treatment decisions.
ClinicalTrials.gov NCT05841498. Registered on May 3, 2023.
新冠后综合征（PCS）影响高达43%的所有感染严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的患者，指急性感染数月后仍持续存在的症状。尽管受影响人数众多，但关于治疗方案的证据仍然非常少。一些研究至少部分表明自身抗体介导的自身免疫起了作用。免疫吸附是一种用于清除循环抗体的体外疗法，已成功应用于多种自身免疫性疾病。我们构思了IAMPOCO试验，以评估免疫吸附对PCS患者的治疗效果。
IAMPOCO是一项单中心随机假对照试验，采用交叉设计，将招募40名PCS患者，其新冠后功能量表症状严重程度至少为2级。所有参与者将接受5次免疫吸附治疗，在8周的洗脱期后接受5次假治疗，反之亦然。首先进行哪种治疗方式将随机分配。患者对接受的治疗方式不知情，但治疗提供者知情。主要结局是通过几种症状评分和握力的变化来衡量免疫吸附对PCS严重程度的疗效。次要结局是不良事件的发生频率、PCS参与者中相关自身抗体的流行率以及治疗和假治疗前后自身抗体的浓度。
该试验解决了PCS治疗方案缺乏证据的问题。通过采用交叉设计并纳入假治疗组，该研究旨在比较同一患者体内免疫吸附和假治疗的效果。该试验还受益于从一项关于PCS患病率的队列研究中招募参与者，确保对症状进行全面评估。由于症状具有主观性，对其进行客观评估具有挑战性，但目前正在使用各种评分系统和测试。尽管缺乏随机对照试验的数据，但本研究的结果有可能显著改善PCS治疗，并支持基于证据的治疗决策。
ClinicalTrials.gov NCT05841498。于2023年5月3日注册。
