Clinical Trial on a Natural Compound to Improve Chronic Inflammation After SARS-CoV-2 Infection

Официальное название

Clinical Trial to Analyze the Effectiveness of a Natural Compound on Chronic Immune-mediated Inflammatory Status in Subjects Who Have Had SARS-CoV-2 Infection.

Обзор

A controlled, randomized clinical trial is proposed to demonstrate the effectiveness of the experimental product in controlling hepato-pulmonary inflammation and neurovascular encephalic inflammation, which may constitute the etiopathogenic basis of persistent COVID. In addition, an individualized training program will be implemented for each participant in order to improve chronic symptoms and, consequently, their quality of life.

Подробное описание

Randomized, placebo-controlled, double-blind clinical trial with four parallel arms based on the product consumed (placebo or experimental product) and the performance of physical exercise (exercise or no exercise), designed to analyze the effectiveness of the product under investigation in reducing chronic immune-mediated inflammatory status in subjects who have had SARS-CoV-2 infection and present persistent symptoms 3 months after the onset of the infectious process.

The efficacy of the experimental product, consumed over a period of 4 months, will be determined in terms of reducing chronic inflammation and improving the quality of life of people suffering from this condition.

Clinical manifestations and chronic symptoms, quality of life, response to the individualized physical exercise program, and product safety will be taken into account.

Вмешательства

• Пищевая добавка Experimental Product
  Supplement consisting of orange extract, apigenin, luteolin, yerba mate extract, grapefruit extract, and olive leaf extract.
• Пищевая добавка Control placebo
  Product with identical characteristics to the experimental product.
• Другое Physical exercise
  During the study, subjects will have to develop a training program. A multicomponent program will be carried out during the 4 months of product consumption. The sessions will last 60 minutes and will be held 2-3 times per week.
• Другое No Physical Exercise
  During the study, subjects will only consume the product assigned to them in the randomization.

Первичные конечные точки

• Immunoinflammatory profile [Срок оценки: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 120 days of product intake.]

Вторичные конечные точки (12)

• Clinical signs [Срок оценки: It will be recorded twice, before starting the consumption of the product and before the end of consumption (120 days)]
• Short Form 12 Health Survey [Срок оценки: It will be measured twice, once at baseline and at the end of the study after 120 days of consumption.]
• Sleep quality [Срок оценки: Progress will be measured after 120 days of consumption.]
• Sleep efficiency [Срок оценки: Progress will be measured after 120 days of consumption.]
• Fatigue [Срок оценки: Progress will be measured after 120 days of consumption.]
• Dyspnea [Срок оценки: Progress will be measured after 120 days of consumption.]
• Depression [Срок оценки: Progress will be measured after 120 days of consumption.]
• Anxiety [Срок оценки: Progress will be measured after 120 days of consumption.]
• Hospital Anxiety and Depression [Срок оценки: Progress will be measured after 120 days of consumption.]
• Stress level [Срок оценки: Progress will be measured after 120 days of consumption.]
• Cardiorespiratory fitness. [Срок оценки: Progress will be measured after 120 days of consumption.]
• The Rate of Force Development [Срок оценки: Progress will be measured after 120 days of consumption.]

Критерии участия

Критерии включения

• Subjects of both sexes.
• Subjects over 18 and under 70 years of age who have had a SARS-CoV-2 infection diagnosed by PDIA.
• Subjects with a history of SARS-CoV-2 infection who, three months after the onset of COVID-19, continue to experience symptoms lasting at least two months that cannot be explained by another cause. These symptoms may be newly developed after initial recovery from an acute COVID-19 episode or persist from the initial illness.
• No history of sequelae from a severe acute illness.

Критерии исключения

• Subjects with an underlying disease that explains the clinical manifestations.
• Presence of chronic inflammatory diseases.
• Subjects with acute infections.
• Evidence of active thromboembolic disorder, defined as those receiving parenteral anticoagulant or thrombolytic treatment.
• Excessive alcohol consumption.
• Hypersensitivity or intolerance to any of the components of the study products.
• Use of any nutraceutical or dietary supplement.
• Severe or terminal illnesses.
• Subjects with a body mass index (BMI) over 32.
• Pregnant or lactating women.

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

Тройное слепое

Основная цель

Другое

Центры проведения

Испания · 1 центр

• UCAM HiTech, Sport & Health Innovation Hub — Murcia

Идентификаторы

NCT: NCT07397910 · UCAMCFE-00038

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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