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

NCT07397910 | Not Yet Recruiting DMC

• 1 other identifier: UCAMCFE-00038
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Long COVID

Keywords

LongCOVID; Nutraceutical; Immune-inflammatory state; Exercise

Outcome Measures

Primary Outcomes (1)

• Immunoinflammatory profile

  Antibody assay for molecular biomarkers of the brain-liver-lung axis, blood-brain barrier, immunometabolic pathways, and immune-inflammatory and immuno-angiogenic cardiac remodeling.

  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.

Secondary Outcomes (16)

• Clinical signs

  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

  It will be measured twice, once at baseline and at the end of the study after 120 days of consumption.

• Sleep quality

  Progress will be measured after 120 days of consumption.

• Sleep efficiency

  Progress will be measured after 120 days of consumption.

• Fatigue

  Progress will be measured after 120 days of consumption.

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Subjects in this group will consume a placebo product (maltodextrin) with the same organoleptic characteristics as the investigational product.

Dietary Supplement: Control placebo; Other: No Physical Exercise

Natural extract

EXPERIMENTAL

Subjects in this group will consume the investigational product (experimental product composed of a combination of six natural extracts: grapefruit extract, apigenin, orange extract, luteolin, yerba mate extract, and olive leaf extract).

Dietary Supplement: Experimental Product; Other: No Physical Exercise

Physical exercise and consumption of experimental product

EXPERIMENTAL

During the study, subjects must consume the experimental product and also follow a training program. A multi-component program will be carried out during the 4 months of product consumption. Sessions will last 60 minutes and will be held 2-3 times per week.

Dietary Supplement: Experimental Product; Other: Physical exercise

Physical exercise and consumption of placebo product

PLACEBO COMPARATOR

During the study, subjects must consume the placebo product and also follow a training program. A multi-component program will be carried out during the 4 months of product consumption. Sessions will last 60 minutes and will be held 2-3 times per week.

Dietary Supplement: Control placebo; Other: Physical exercise

Interventions

Experimental Product DIETARY_SUPPLEMENT

Supplement consisting of orange extract, apigenin, luteolin, yerba mate extract, grapefruit extract, and olive leaf extract.

Natural extract; Physical exercise and consumption of experimental product

Control placebo DIETARY_SUPPLEMENT

Product with identical characteristics to the experimental product.

Physical exercise and consumption of placebo product; Placebo

Physical exercise OTHER

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.

Physical exercise and consumption of experimental product; Physical exercise and consumption of placebo product

No Physical Exercise OTHER

During the study, subjects will only consume the product assigned to them in the randomization.

Natural extract; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

UCAM HiTech, Sport & Health Innovation Hub

Murcia, Spain

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Francisco Javier López Román

CONTACT

968278157; jlroman@ucam.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind study in relation to product consumption. Blinding cannot be performed in relation to physical exercise.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor of Medicine

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 9, 2026
• Study Start: February 23, 2026
• Primary Completion: July 6, 2026
• Study Completion (Estimated): August 3, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)