Immunoadsorption in Autoimmune Long COVID
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Immunoadsorption, Sham Comparator.
- Кому может быть актуально
- Состояния в реестре: Long COVID, Long COVID Syndrome, Long COVID-19 Syndrome, Post COVID Syndrome. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Placebo-Controlled, Double-Blind, Randomized Trial Phase I-II With Immunoadsorption in Autoimmune Long COVID
Обзор
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.
Подробное описание
Growing evidence indicates that autoantibodies may drive symptoms in a subset of people with long COVID, as demonstrated by symptom transfer to mice following administration of IgG from affected patients. This provides a strong rationale for targeted immunotherapy aimed at removing pathogenic antibodies. Immunoadsorption is a well-established method to reduce circulating IgG, but studies suggest that only a specific subgroup of patients benefits.
Using HuProt autoantibody microarray technology, we identified several autoantibodies uniquely present in long COVID patients compared with healthy controls. We subsequently developed and validated a disease-specific Luminex multiplex immunoassay to detect this autoimmune phenotype. This study will use these findings as a novel selection method of identifying long COVID patients with pathogenic IgG, thereby enriching the population most likely to benefit from immunoadsorption therapy.
This biomarker-guided personalized medicine approach could enhance treatment efficacy and advances long COVID therapeutic strategies. Additionally, the placebo-controlled and double blinded design will be needed to evaluate the true potential of autoantibodies adsorption therapy in long COVID. This study can add to our understanding on the role of autoantibodies in the pathogenesis of long COVID and could help in the development of precision-based immunotherapy for patients such as immunoadsorption.
Вмешательства
- Устройство Immunoadsorption
Immunoadsorption will be performed using tryptophan columns, which bind the Fc region of IgG via hydrophobic and aromatic interactions. - Устройство Sham Comparator
The 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.
Первичные конечные точки
- Change in fatigue measured by the Fatigue Assessment Scale (FAS) [Срок оценки: At baseline and 28 days after start treatment]
Вторичные конечные точки (8)
- Change in health related quality of life using the 36-Item Short Form Health Survey (SF-36) [Срок оценки: At baseline and days 28, 60, 90, and 180]
- Change in cognitive functioning using the Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function Short Form 8a (PROMIS Cognitive Function Short Form 8a) [Срок оценки: At baseline and days 28, 60, 90, and 180]
- Change in autonomic symptoms using the Composite Autonomic Symptom Score-31 (COMPASS-31) [Срок оценки: At baseline and days 28, 60, 90, and 180]
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) related to the intervention [Срок оценки: From first study intervention through day 180]
- Repeated Handgrip Strength [Срок оценки: At baseline and days 28, 60, 90, and 180]
- Orthostatic intolerance using the NASA lean test [Срок оценки: At baseline and days 28 and 180]
- Efficacy treatment by measuring immunoglobuline titers [Срок оценки: At baseline (prior to treatment initiation), during treatment, and at days 28 and 180 after treatment initiation.]
- Autoantibody score using an in-house Luminex assay [Срок оценки: At screening and on days 28, 60, 90, and 180]
Критерии участия
Критерии включения
- 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)
Критерии исключения
- 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
- Solid organ malignancy in the last 5 years
- Active psychiatric disorder currently under treatment by a psychiatrist
- BMI > 35
- Pre-existing fatigue
- Poor performance score prior to the long COVID diagnosis (WHO performance >0)
- Pregnancy or breastfeeding
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Нидерланды · 1 центр
- AUMC — Amsterdam
Идентификаторы
NCT: NCT07316127 · NL-009359