Status:
ACTIVE_NOT_RECRUITING
Nutritional Intervention and Rehabilitation Treatment in Patients With Post-COVID Condition
Lead Sponsor:
Instituto de Investigación Sanitaria Aragón
Collaborating Sponsors:
Solutex GC S.L.
Conditions:
Post-COVID Condition
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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...
Detailed Description
Patients who have contracted COVID-19 usually show various symptoms during the infection: Fever, cough, generalized pain, gastrointestinal disturbances, dyspnea, and fatigue. The latter two symptoms o...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
Key Trial Info
Start Date :
September 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT06063031
Start Date
September 26 2022
End Date
April 30 2025
Last Update
November 15 2024
Active Locations (1)
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1
IIS Aragón
Zaragoza, Spain