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

ConditionLong COVID
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversidad Católica San Antonio de Murcia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental Product

    Dietary supplement

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

  • Control placebo

    Dietary supplement

    Product with identical characteristics to the experimental product.

  • Physical exercise

    Other intervention

    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.

  • No Physical Exercise

    Other intervention

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

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: PlaceboPlacebo comparator 2 interventions
Group B: Natural extractExperimental treatment 2 interventions
Group C: Physical exercise and consumption of experimental productExperimental treatment 2 interventions
Group D: Physical exercise and consumption of placebo productPlacebo comparator 2 interventions

Trial outcomes

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.

Time frame
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

1

Clinical signs

The number of clinical manifestations, the type of manifestation, intensity according to the visual analog scale from 0 to 10, and duration of the symptomps. The clinical manifestations will be those felt by the subject.

Time frame
It will be recorded twice, before starting the consumption of the product and before the end of consumption (120 days)
2

Short Form 12 Health Survey

Measured by SF-12 questionnaire. Scale 0-100%

Time frame
It will be measured twice, once at baseline and at the end of the study after 120 days of consumption.
3

Sleep quality

Measured by Pittsburgh test

Time frame
Progress will be measured after 120 days of consumption.
4

Sleep efficiency

Measured by accelerometry, with Actigraph wGT3X-BT

Time frame
Progress will be measured after 120 days of consumption.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Católica San Antonio de Murcia

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: