Study on Post-Acute COVID-19 Syndrome: Effects of Diet, Exercise, Metformin, and Sirolimus on Frailty and Immune Function in Affected Patients

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What is this study about?

This clinical trial is focused on studying a condition known as Post-acute COVID-19 syndrome (PACS), which can occur after recovering from COVID-19. The study aims to explore how certain treatments might help improve physical performance and restore immune functions in people experiencing this syndrome. The treatments being tested include a combination of lifestyle changes, such as diet and exercise, along with medications like metformin and sirolimus (also known as rapamycin). Metformin is commonly used to manage blood sugar levels in people with diabetes, while sirolimus is an immunosuppressant, which means it helps control the immune system.

The purpose of the study is to see if these treatments can help improve the physical abilities and overall health of individuals with PACS. Participants will be randomly assigned to different groups, where they will receive either the lifestyle changes alone or in combination with one of the medications. The study will last for about three years, during which participants will be monitored to assess changes in their physical performance and immune function. The study will also look at the quality of life and any potential side effects of the treatments.

Throughout the study, participants will undergo various assessments to track their progress. These assessments will include measuring physical performance using a tool called the Short Physical Performance Battery, which evaluates balance, walking speed, and leg strength. The study will also examine changes in blood cells and inflammation levels to understand how the treatments might affect the immune system. By the end of the study, researchers hope to gain valuable insights into how these interventions can help people with PACS regain their strength and improve their overall well-being.

1 enrollment and initial assessment

Upon joining the study, you will undergo an initial assessment to confirm your eligibility. This includes verifying your diagnosis of post-acute COVID syndrome (PACS) and ensuring you meet the age and health criteria.

You will be asked to provide written consent to participate in the trial.

2 randomization and group assignment

After the initial assessment, you will be randomly assigned to one of the study groups. Each group will follow a different treatment plan involving lifestyle changes and possibly medication.

3 lifestyle intervention

All participants will engage in a lifestyle intervention program focused on diet and exercise. This program is designed to improve physical performance and overall health.

4 medication administration

Depending on your group assignment, you may receive metformin or sirolimus as part of the treatment. Both medications are taken orally.

The dosage and frequency of the medication will be determined by the study protocol and communicated to you by the study team.

5 ongoing assessments

Throughout the trial, you will undergo regular assessments to monitor your physical performance, frailty status, and quality of life.

These assessments will include tests like the Short Physical Performance Battery and questionnaires to evaluate your health and well-being.

6 blood tests and monitoring

You will have periodic blood tests to analyze changes in your immune system and inflammation levels. This helps in understanding the effects of the treatment on your health.

The study team will also monitor for any adverse events or changes in your clinical condition.

7 completion of the trial

The trial is expected to last for two years. At the end of the study, a final assessment will be conducted to evaluate the overall impact of the treatment on your health.

Results from the trial will contribute to understanding how to better manage post-acute COVID syndrome.

Who Can Join the Study?

Have a confirmed diagnosis of Post-acute COVID syndrome (PACS) based on two clinical assessments.
Have been previously admitted to the hospital for Severe COVID Pneumonia.
Be between the ages of 40 and 80 years.
Have a status of frailty or pre-frailty, which means showing signs of weakness or being at risk of becoming weak, as determined by specific criteria.
Be independently mobile, meaning able to move around without assistance.
Be able and willing to provide written consent to participate in the study.

Who Cannot Join the Study?

Individuals who do not have a diagnosis of Post-acute COVID syndrome (PACS) cannot participate. This means the study is only for those who have ongoing symptoms after recovering from COVID-19.
People who are not within the specified age range cannot participate. The study is for adults, so children and very elderly individuals may not be eligible.
Participants must be able to undergo lifestyle interventions and possibly take medications like metformin or rapamycin. If someone cannot do this, they may be excluded.
Both males and females can participate, but those who are considered part of a vulnerable population, such as pregnant women or those with severe health issues, may not be eligible.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.06.2023

Trial locations

Investigated drugs:

Rapamycin is a medication that is being studied for its potential to help improve physical performance and immune function in people who have experienced post-acute COVID-19 syndrome (PACS). It is thought to work by affecting the body’s aging process, which might help reduce frailty and improve overall health.

Metformin is a medication commonly used to manage blood sugar levels in people with diabetes. In this study, it is being explored for its potential benefits in improving physical performance and immune function in individuals with PACS. Researchers are interested in seeing if metformin can help reduce frailty and support better health outcomes in these patients.

Investigated diseases:

COVID-19

Post-acute COVID-19 syndrome – This condition, also known as long COVID, occurs in individuals who have recovered from the acute phase of COVID-19 but continue to experience symptoms. It can affect multiple organ systems and is characterized by a wide range of symptoms such as fatigue, shortness of breath, and cognitive difficulties. The progression of post-acute COVID-19 syndrome varies among individuals, with some experiencing persistent symptoms for weeks or months. The condition may involve ongoing inflammation and immune system dysregulation. Symptoms can fluctuate, with periods of improvement followed by relapses. The exact mechanisms underlying the syndrome are still being studied.

Trial ID:

2023-504641-32-00

Protocol code:

Gero-PACS

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Post-Acute COVID-19 Syndrome: Effects of Diet, Exercise, Metformin, and Sirolimus on Frailty and Immune Function in Affected Patients

What is this study about?

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