IMMUNERECOV CONTRIBUTES TO IMPROVEMENT OF RESPIRATORY AND IMMUNOLOGICAL RESPONSE IN POST-COVID-19 PATIENTS.

Last updated: December 10, 2023
Sponsor: Federal University of São Paulo
Overall Status: Active - Recruiting

Phase

3

Condition

Inflammation

Diet And Nutrition

Covid-19

Treatment

Nutritional blend (ImmuneRecov).

Clinical Study ID

NCT06166030
4.637.661
  • Ages > 18
  • All Genders

Study Summary

Background: COVID-19 left consequences in different organs from months to years requiring different types of rehabilitation. In fact, a severe loss in the lung function, and in the respiratory and peripheral muscle strength is commonly observed in post-COVID-19 patients. Objectives: Thus, the present study investigated whether 30 days of supplementation with a nutritional blend (ImmuneRecov®; composition: whey protein concentrate, astaxanthin, creatine, selenium, vitamin C, glutamic acid, tryptophan, magnesium) would help to minimize the respiratory (lung function) and muscular (respiratory and peripheral muscles) sequelae in post-COVID-19 patients.

Eligibility Criteria

Inclusion

Inclusion Criteria: The inclusion criteria encompassed post-COVID-19 patients with aconfirmed COVID-19 diagnosis through a positive RT-PCR test, who also requiredhospitalization, meeting the criteria for moderate severity classification as defined bythe World Health Organization (WHO). In summary, according to the WHO, moderate illness ischaracterized by individuals who exhibit signs of lower respiratory disease during clinicalassessment or imaging and maintain an oxygen saturation level (SpO2) of ≥94% whilebreathing room air at sea level.

Exclusion

Exclusion Criteria: Exclusion criteria included individuals discharged from the hospitalfor more than 14 days and those who initiated physical activity or began taking any dietarysupplements or vitamins.

Study Design

Total Participants: 58
Treatment Group(s): 1
Primary Treatment: Nutritional blend (ImmuneRecov).
Phase: 3
Study Start date:
December 10, 2023
Estimated Completion Date:
December 15, 2024

Study Description

Background: COVID-19 left consequences in different organs from months to years requiring different types of rehabilitation. In fact, a severe loss in the lung function, and in the respiratory and peripheral muscle strength is commonly observed in post-COVID-19 patients. Objectives: Thus, the present study investigated whether 30 days of supplementation with a nutritional blend (ImmuneRecov®; composition: whey protein concentrate, astaxanthin, creatine, selenium, vitamin C, glutamic acid, tryptophan, magnesium) would help to minimize the respiratory (lung function) and muscular (respiratory and peripheral muscles) sequelae in post-COVID-19 patients. Design: This is a non-controlled open label prospective clinical study. Methods: Fifty-eight post-COVID-19 patients were recruited and twenty-four accepted to take the nutritional blend, while twenty-four did not accept but required to participate in the evaluations and 10 refused to participate. So, the patients were evaluated before the 14th day after hospital discharge and after 30 days of use of the nutritional blend or control (no supplementation).

Connect with a study center

  • Laboratory of Pulmonary and Exercise Immunology - Federal University of Sao Paulo

    São José dos Campos, SP 12231-280
    Brazil

    Active - Recruiting

  • Laboratory of Pulmonary and Exercise Immunology

    Sao Jose dos Campos, Sao Paulo 12231280
    Brazil

    Active - Recruiting

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