Long Covid19Phase 3IRPCNCT06166030
IMMUNERECOV CONTRIBUTES TO IMPROVEMENT OF RESPIRATORY AND IMMUNOLOGICAL RESPONSE IN POST-COVID-19 PATIENTS.
A Phase 3 study testing Nutritional blend (ImmuneRecov). in people with Long Covid19 and Dietary Supplements, run by Federal University of São Paulo at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Covid19, Dietary Supplements, Respiratory Tract Infections
- What is being tested?
- Nutritional blend (ImmuneRecov).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesBrazil
- Study dates
- 10 Dec 2023to 15 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Laboratory of Pulmonary and Exercise Immunology - Federal University of Sao Paulo
São José dos Campos, São Paulo, 12231-280
Rodolfo de Paula Vieira, MSc., PhD., +55 12 99141-0615, rpvieira@unifesp.br
Rodolfo de Paula Vieira, MSc., PhD, +55 12 99141-0615, rpvieira@unifesp.br
- Recruiting
Laboratory of Pulmonary and Exercise Immunology
São José dos Campos, São Paulo, 12231280
Rodolfo de Paula Vieira, MSc., PhD., 55 12 991410615, rpvieira@unifesp.br
Rodolfo de Paula Vieira, MSc., PhD, 55 12 991410615, rpvieira@unifesp.br
About this study
Official title: 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.
Read the 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).
- Being tested
- Nutritional blend (ImmuneRecov).
- Keywords
- COVID-19, dietary supplementation, inflammation, lung function, muscle strength, SARS-CoV-2
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Respiratory Tract Infections, Inflammation, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional blend (ImmuneRecov).Dietary supplement
Effects of 30 days supplementation with ImmuneRecov on Peripheral and Respiratory Muscle Strength, on Lung Function and Immune Response.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Dietary Supplement: Nutritional blend (ImmuneRecov). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of ImmuneRecov on Lung Function and Immune Response
Effects of ImmuneRecov on Lung Function and Immune Response
Measured: 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
Measured: Effects of 30 days of ImmuneRecov supplementation on Peripheral and Respiratory Muscle Strength
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start10 Dec 2023
- Primary completion10 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Long Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodolfo de Paula Vieira, Federal University of São Paulo
- Investigators
- Rodolfo de Paula Vieira, BSc., MSc., PhD., Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166030
- Sponsor's protocol ID
- 4.637.661
- Acronym
- IRPC
- Status last verified
- Dec 2023
- First submitted
- 10 Dec 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected and all measurements done will be shared and properly explained to all participants in a private and previously scheduled meeting
Publications
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.
PubMed 35706399Franco 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.
PubMed 36011562Wang 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.
PubMed 35814201
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF WHEY PROTEIN SUPPLEMENTATION ON CARDIOPULMONARY, MUSCLE AND IMMUNOHEMATOLOGICAL RESPONSES OF POST-COVID-19 PATIENTS.
- ClinicalTrials.gov ID
- NCT06166030
- Acronym / sponsor ID
- IRPC / 4.637.661
- Keywords
- COVID-19, dietary supplementation, inflammation, lung function, muscle strength, SARS-CoV-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effects of ImmuneRecov on Lung Function and Immune Response | Experimental | Dietary Supplement: Nutritional blend (ImmuneRecov).Effects of 30 days supplementation with ImmuneRecov on Lung Function and Immune Response of post-COVID-19 patients. |
| Effects of 30 days supplementation with ImmuneRecov on Peripheral and Respiratory Muscle Strength | Experimental | Dietary Supplement: Nutritional blend (ImmuneRecov).Effects of 30 days supplementation with ImmuneRecov on Peripheral and Respiratory Muscle Strength |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional blend (ImmuneRecov).Effects of 30 days supplementation with ImmuneRecov on Peripheral and Respiratory Muscle Strength, on Lung Function and Immune Response. | Dietary supplement | Effects of 30 days supplementation with ImmuneRecov on Peripheral and Respiratory Muscle Strength, Effects of ImmuneRecov on Lung Function and Immune Response |
Primary outcome
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
1 secondary outcome
Effects of ImmuneRecov on Peripheral and Respiratory Muscle Strength
Time frame: Effects of 30 days of ImmuneRecov supplementation on Peripheral and Respiratory Muscle Strength
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Background: PubMed 35706399Prokopidis 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.
- Background: PubMed 36011562Franco 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.
- Background: PubMed 35814201Wang 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.
- Individual participant dataSharing planned: Yes. All data collected and all measurements done will be shared and properly explained to all participants in a private and previously scheduled meeting
Related trials for Long Covid19
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Not yet recruitingPhase 3
Dapagliflozin for Long COVID Syndrome
COVID - 19, Long COVID Syndrome
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
RecruitingPhase 2
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
Post-acute Sequelae of COVID-19, Long COVID
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodolfo de Paula Vieira, BSc., MSc., PhD. principal investigator
Federal University of São Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nutritional blend (ImmuneRecov). in people with Long Covid19 and Dietary Supplements, run by Federal University of São Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodolfo de Paula Vieira, BSc., MSc., PhD. (55 12 991410615, rodrelena@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of ImmuneRecov on Lung Function and Immune Response (time frame: Effects of 30 days supplementation with ImmuneRecov on Lung Function and Immune Response). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06166030, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.