Идёт набор NCT06825819

Dysbiosis & Long COVID

— Наблюдательное COVID-19

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: Subjects with and without Long COVID.
Кому может быть актуально: Состояния в реестре: COVID-19. Базовые параметры: 18 лет — 80 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: США
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

DETERMINING THE IMPACT OF MICROBIAL DYSBIOSIS ON IMMUNE AND BARRIER DYSFUNCTION IN LONG COVID

Обзор

The SARS-CoV-2 virus causes COVID-19, which ranges from mild initial symptoms to severe multi-organ dysfunction. While some patients recover to their baseline states, others develop a long COVID, or post-acute sequelae of SARS-CoV-2 (PASC) consisting of symptoms persisting \>2-6 months post-infection. PASC symptoms include post-exertional malaise, fatigue, and heart palpitations as well as incident GI disorders, cognitive dysfunction, and arthritis. Based on prevalence/incidence studies, it is estimated that more than 30 million people in the US have ever developed PASC with 10-11% of patients or 11 million people continuing to feel symptoms to the present day10. SARS-CoV-2 vaccines are only \~32% effective against infection at 4 months post-vaccination11, only 15% effective against the development of PASC12, and only 20% of American adults have received an updated booster as of December 202313. It is therefore imperative that the scientific community make progress in identifying underlying causes of PASC to develop effective treatments. This study will identify microbial metabolites associated with PASC-mediated gut dysbiosis and establish a tractable in vitro model to test T cell-gut epithelium dynamics to develop novel bio-therapeutics for multiple post-viral conditions. This case-control study will collect biospecimens (matched stool \& blood) samples from 400 people with and without long COVID (200 participants/group) to understand how COVID-induced dysbiosis impacts symptom severity, immune suppression, and gut barrier dysfunction both ex vivo and in vitro.

Вмешательства

Биопрепарат Subjects with and without Long COVID
To collect biospecimens (matched stool \& blood) samples from 400 people with and without long COVID (200 participants/group) to understand how COVID-induced dysbiosis impacts symptom severity, immune suppression, and gut barrier dysfunction both ex vivo and in vitro.

Первичные конечные точки

To determine whether people with long COVID exhibit microbial dysbiosis characterized by decreased bacterial diversity, overgrowth of Bacteroides taxa, and lower SCFA, indole, and secondary bile acid production with biospecimen collections [Срок оценки: At baseline until final values]

Вторичные конечные точки (1)

To collect matched stool, blood, and intestinal biopsy samples from a cohort of 300 individuals with and without long COVID (150/group) [Срок оценки: At baseline until final values]

Критерии участия

Критерии включения

Age: 18-80
Sex: Any
Race: Any
Last COVID infection: within past 3 years, PCR- or antigen-confirmed, symptomatic (mild/moderate/severe)
COVID vaccination status: Any
Presence of long COVID symptoms (GI, cardiac, pulmonary, neuro, musculoskeletal, and/or psych): 200 with symptoms, 200 w/o symptoms as defined by SBQ-LCTM.
May or may not be doing routine endoscopy at UCM

Критерии исключения

Age <18 or >80
Last COVID infection >3 years ago (PCR/antigen-confirmed, symptomatic)
Currently or within the last 3 months COVID+ by nasopharyngeal PCR/antigen test
Currently diagnosed with cancer
Currently pregnant (cannot take colon biopsy sample; only eligible for survey/blood \& stool collection)
Currently on biologic immunomodulatory medications
Official diagnosis of irritable bowel disease (IBD) or other chronic GI disorder

Vulnerable and/or Special Populations