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NCT06063031

Nutritional Intervention and Rehabilitation Treatment in Patients With Post-COVID Condition

Sponsor: Instituto de Investigación Sanitaria Aragón

View on ClinicalTrials.gov

Summary

SARS-CoV-2 is the coronavirus responsible for developing the disease known as COVID-19. Once the acute phase of the disease has passed, about 40% of the people who discharged continue to have symptoms, and of these, between 50 and 70% present them up to three months later. These persistent symptoms include physical aspects such as fatigue and dyspnea, but also cardiac such as palpitations, cognitive such as mental confusion, and psycho-emotional such as depression, anxiety, and stress. SARS-CoV-2 infection is associated with a hyperinflammatory state, including excessive inflammatory cell infiltration, inflammasomes activation. In this context, omega-3 metabolites (Special Pro-resolving Mediators-SPMs) restore the balance in nutritional and molecular levels of eicosanoids. A more direct and targeted way to increase SPMs levels is Omega3 Essential Nutrition with natural SPMs taken by mouth. Today, there are dietary supplements containing SPMs (LIPINOVA®), made from fish oil through a fractionation process. LIPINOVA® is a nutritional supplement patented by Solutex GC S.L., obtained through several fractionation stages (extraction, purification, separation, concentration) from rich-in-omega-3 fish oil (without additives). Each capsule contains 498 mg of fish oil and 2 mg of tocopherols. This represents a variable quantity from 50 to 150 mg of EPA (20%), a variable quantity from 100 to 225 mg of DHA (30%), as well as the following quantities of EPA and DHA active metabolites, obtained from a pool of natural lipid mediators contained in omega-3 oil: 40-200 mcg of 17-HDHA, 25-200 mcg of 18-HEPE and 20-100 mcg of 14-HDHA. In addition to this, the appearance of this new health condition, post-COVID condition, has once again led physiotherapists to update themselves in search of the best evidence to guide the examination and necessary rehabilitation interventions in this type of patient. Studies have shown how physiotherapy sessions that include a multimodal program could be the most indicated for this type of patients. Patients with this condition present an increase in fatigue, dyspnea and a decrease in their functional capacity and, therefore, a decrease in their quality of life, due to various pathogenic mechanisms that include chronic hyperinflammation. These patients could obtain greater health improvements in terms of their quality of life if a therapeutical exercise and education program based on tele-rehabilitation is implemented together with a natural nutritional supplement that generates a systemic anti-inflammatory effect through SPMs (omega- 3).

Official title: Investigation of a Specialized Nutritional Intervention and Rehabilitation Treatment in Patients With Post-COVID Condition to Improve Their Quality of Life: ARACOV-02

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

146

Start Date

2022-09-26

Completion Date

2025-04-30

Last Updated

2026-06-30

Healthy Volunteers

Conditions

Post-COVID Condition

Interventions

DIETARY_SUPPLEMENT

Active

Active nutritional supplement plus telerehabilitation

OTHER

Placebo

Placebo nutritional supplement plus telerehabilitation

Inclusion Criteria: * To have signed the informed consent form. * Age between 18 and 70 years with access to and knowledge of basic use of technological applications. * Patients with clinical criteria of having suffered from COVID-19 with diagnosis confirmed by diagnostic techniques and systems in health centers (PCR, rapid antigen test, and/or serology (positive anti-N antibodies). * Patients who remain symptomatic for more than 12 weeks after the onset of symptoms. * Patients who manifest symptoms compatible with CPCOVID since the end of the acute phase\*. * Patients with fatigue greater than or equal to an average of 4 points on the FSS. * Independent ambulation, even with the use of technical aids. Exclusion Criteria: * Patients with severe neurological diseases at the central and/or peripheral level that prevent them from following the program. * Patients with respiratory insufficiency: SaO2 \< 90% or respiratory rate ≧30. * Patients with rheumatic diseases or acute musculoskeletal injuries that do not allow exercise. * Patients who do not have access to the Internet or are unable to use the Internet on a daily basis. * Patients with clinical symptoms consistent with chronic fatigue syndrome (In the end, this criterion was not applied in the study) * Presence of symptoms consistent with CPCOVID prior to SARS Cov-2 infection. * Pregnant or lactating women or women of childbearing age who are trying to become pregnant. * Patients unable to follow oral and written instructions in Spanish. * Patients with an allergy to fish, shellfish, or any of the ingredients of the preparation. * Patients enrolled in another clinical trial for the treatment of symptomatology derived from COVID -19. * Patients who have completed another clinical trial in the 4 weeks prior to enrollment. * Patients who have received immunosuppressive medications and/or corticosteroids in the last 2 weeks prior to enrollment. Patients who have received nonsteroidal anti-inflammatory drugs (NSAIDs) continuously or on a fixed regimen in the 2 weeks prior to treatment initiation. Patients who have been taking NSAIDs may have a 7-day withdrawal period. * Women of childbearing age who are not willing to take NSAIDs should not be treated.

Locations (1)

IIS Aragón

Zaragoza, Spain