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

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.

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.