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

NCT ID: NCT06166030

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-10

Study Completion Date

2024-12-15

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Long Covid19 Dietary Supplements Respiratory Tract Infections Inflammation

Keywords

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COVID-19 dietary supplementation inflammation lung function muscle strength SARS-CoV-2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Effects of ImmuneRecov on Lung Function and Immune Response

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

Group Type EXPERIMENTAL

Nutritional blend (ImmuneRecov).

Intervention Type DIETARY_SUPPLEMENT

Effects of 30 days supplementation with ImmuneRecov on Peripheral and Respiratory Muscle Strength, on Lung Function and Immune Response.

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

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

Group Type EXPERIMENTAL

Nutritional blend (ImmuneRecov).

Intervention Type DIETARY_SUPPLEMENT

Effects of 30 days supplementation with ImmuneRecov on Peripheral and Respiratory Muscle Strength, on Lung Function and Immune Response.

Interventions

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Nutritional blend (ImmuneRecov).

Effects of 30 days supplementation with ImmuneRecov on Peripheral and Respiratory Muscle Strength, on Lung Function and Immune Response.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Rodolfo de Paula Vieira

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rodolfo de Paula Vieira, BSc., MSc., PhD.

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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

São José dos Campos, São Paulo, Brazil

Site Status RECRUITING

Laboratory of Pulmonary and Exercise Immunology

São José dos Campos, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Rodolfo de Paula Vieira, BSc., MSc., PhD.

Role: CONTACT

Phone: 55 12 991410615

Email: [email protected]

Facility Contacts

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Rodolfo de Paula Vieira, MSc., PhD.

Role: primary

Rodolfo de Paula Vieira, MSc., PhD

Role: backup

Rodolfo de Paula Vieira, MSc., PhD.

Role: primary

Rodolfo de Paula Vieira, MSc., PhD

Role: backup

References

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Prokopidis K, Mazidi M, Sankaranarayanan R, Tajik B, McArdle A, Isanejad M. Effects of whey and soy protein supplementation on inflammatory cytokines in older adults: a systematic review and meta-analysis. Br J Nutr. 2023 Mar 14;129(5):759-770. doi: 10.1017/S0007114522001787. Epub 2022 Jun 16.

Reference Type BACKGROUND
PMID: 35706399 (View on PubMed)

Franco JVA, Garegnani LI, Oltra GV, Metzendorf MI, Trivisonno LF, Sgarbossa N, Ducks D, Heldt K, Mumm R, Barnes B, Scheidt-Nave C. Long-Term Health Symptoms and Sequelae Following SARS-CoV-2 Infection: An Evidence Map. Int J Environ Res Public Health. 2022 Aug 11;19(16):9915. doi: 10.3390/ijerph19169915.

Reference Type BACKGROUND
PMID: 36011562 (View on PubMed)

Wang S, Qi X. The Putative Role of Astaxanthin in Neuroinflammation Modulation: Mechanisms and Therapeutic Potential. Front Pharmacol. 2022 Jun 24;13:916653. doi: 10.3389/fphar.2022.916653. eCollection 2022.

Reference Type BACKGROUND
PMID: 35814201 (View on PubMed)

Other Identifiers

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4.637.661

Identifier Type: -

Identifier Source: org_study_id