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

Federal University of São Paulo

Status and phase: Enrolling; Phase 3

Conditions: Long Covid19; Inflammation; Respiratory Tract Infections; Dietary Supplements

Treatments: Dietary Supplement: Nutritional blend (ImmuneRecov).

Study type: Interventional

Funder types: Other

Identifiers

NCT06166030

4.637.661

Details and patient eligibility

About

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.

Full 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).

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Effects of ImmuneRecov on Lung Function and Immune Response

Experimental group

Description:

Effects of 30 days supplementation with ImmuneRecov on Lung Function and Immune Response of post-COVID-19 patients.

Treatment:

Dietary Supplement: Nutritional blend (ImmuneRecov).

Effects of 30 days supplementation with ImmuneRecov on Peripheral and Respiratory Muscle Strength

Experimental group

Description:

Effects of 30 days supplementation with ImmuneRecov on Peripheral and Respiratory Muscle Strength

Treatment:

Dietary Supplement: Nutritional blend (ImmuneRecov).