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

December 10, 2023 updated by: Rodolfo de Paula Vieira, Federal University of São Paulo

EFFECTS OF WHEY PROTEIN SUPPLEMENTATION ON CARDIOPULMONARY, MUSCLE AND IMMUNOHEMATOLOGICAL RESPONSES OF POST-COVID-19 PATIENTS.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • SP
      • São José dos Campos, SP, Brazil, 12231-280
        • Recruiting
        • Laboratory of Pulmonary and Exercise Immunology - Federal University of Sao Paulo
        • Contact:
          • Rodolfo de Paula Vieira, MSc., PhD.
          • Phone Number: +55 12 99141-0615
          • Email: rpvieira@unifesp.br
        • Contact:
          • Rodolfo de Paula Vieira, MSc., PhD
          • Phone Number: +55 12 99141-0615
          • Email: rpvieira@unifesp.br
        • Principal Investigator:
          • Rodolfo de Paula Vieira, PhD
    • Sao Paulo
      • Sao Jose dos Campos, Sao Paulo, Brazil, 12231280
        • Recruiting
        • Laboratory of Pulmonary and Exercise Immunology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rodolfo de Paula Vieira, MSc., PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: Nutritional blend (ImmuneRecov).
Effects of 30 days supplementation with ImmuneRecov on Peripheral and Respiratory Muscle Strength, on Lung Function and Immune Response.
Experimental: Effects of 30 days supplementation with ImmuneRecov on Peripheral and Respiratory Muscle Strength
Dietary supplement: Nutritional blend (ImmuneRecov).
Effects of 30 days supplementation with ImmuneRecov on Peripheral and Respiratory Muscle Strength, on Lung Function and Immune Response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of ImmuneRecov on Lung Function and Immune Response
Time Frame: Effects of 30 days supplementation with 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of ImmuneRecov on Peripheral and Respiratory Muscle Strength
Time Frame: Effects of 30 days of ImmuneRecov supplementation on Peripheral and Respiratory Muscle Strength
Effects of 30 days of ImmuneRecov supplementation on Peripheral and Respiratory Muscle Strength
Effects of 30 days of ImmuneRecov supplementation on Peripheral and Respiratory Muscle Strength

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Rodolfo de Paula Vieira, BSc., MSc., PhD., Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2023

Primary Completion (Estimated)

December 10, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

December 10, 2023

First Submitted That Met QC Criteria

December 10, 2023

First Posted (Estimated)

December 12, 2023

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 10, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4.637.661

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data collected and all measurements done will be shared and properly explained to all participants in a private and previously scheduled meeting

IPD Sharing Time Frame

Beginning: 11 December 2023. End: 31 January 2024.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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