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

NCT06166030 | Unknown Phase 3 DMC

• 1 other identifier: 4.637.661
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Long Covid19; Dietary Supplements; Respiratory Tract Infections; Inflammation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Effects of ImmuneRecov on Lung Function and Immune Response

  Effects of ImmuneRecov on Lung Function and Immune Response

  Effects of 30 days supplementation with ImmuneRecov on Lung Function and Immune Response

Secondary Outcomes (1)

• Effects of ImmuneRecov on Peripheral and Respiratory Muscle Strength

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

Study Arms (2)

Effects of ImmuneRecov on Lung Function and Immune Response

EXPERIMENTAL

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

Dietary Supplement: Nutritional blend (ImmuneRecov).

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

EXPERIMENTAL

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

Dietary Supplement: Nutritional blend (ImmuneRecov).

Interventions

Nutritional blend (ImmuneRecov). 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 ImmuneRecov on Lung Function and Immune Response

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (2)

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

São José dos Campos, São Paulo, 12231-280, Brazil

RECRUITING

Laboratory of Pulmonary and Exercise Immunology

São José dos Campos, São Paulo, 12231280, Brazil

RECRUITING

Related Publications (3)

• 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.

  PMID: 35706399 BACKGROUND

• 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.

  PMID: 36011562 BACKGROUND

• 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.

  PMID: 35814201 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Respiratory Tract Infections; Inflammation; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

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

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

55 12 991410615; rodrelena@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: December 12, 2023
• Study Start: December 10, 2023
• Primary Completion: December 10, 2024
• Study Completion: December 15, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning: 11 December 2023. End: 31 January 2024.
• Access Criteria: The principal investigator will have access to IPS and all data through data bank used in the Laboratory of Pulmonary and Exercise Immunology.

Locations

BR (2)