#1 Clinical Trials Search in Europe

Study on Metformin and Colchicine for Patients with Long COVID Symptoms

3 1 1

What is this study about?

This clinical trial is focused on studying treatments for Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), which refers to the long-term effects some people experience after recovering from COVID-19. The study will evaluate the effectiveness of two medications: Metformin and Colchicine. Metformin is commonly used to manage blood sugar levels in people with diabetes, while Colchicine is often used to reduce inflammation and treat conditions like gout.

The purpose of the study is to understand how these treatments impact the physical health-related quality of life for individuals experiencing PASC. Participants will be randomly assigned to receive either Metformin, Colchicine, or a placebo. The study will last for a period of 12 weeks, during which participants will take the assigned treatment orally in tablet form. The maximum daily dose for Metformin is 1500 mg, and for Colchicine, it is 1 mg. The study will monitor the participants’ health and any changes in their symptoms throughout this period.

At the end of the 12 weeks, the study will assess the participants’ physical health using a standardized questionnaire. This will help determine if the treatments have improved their quality of life. The study will also look at other aspects of health, such as mental well-being and the ability to perform daily activities. The findings from this trial could provide valuable insights into managing the long-term effects of COVID-19.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, residence, and the presence of persistent symptoms related to post-acute sequelae of SARS-CoV-2 infection (PASC) for at least 12 weeks after infection.

Confirmation of a previous SARS-CoV-2 infection is required through a positive test or a diagnosis by a medical specialist.

2 informed consent

Participants must provide informed consent, indicating their willingness to participate and comply with trial procedures.

Consent includes allowing the exchange of relevant medical information between the participant’s general practitioner or pharmacy and the trial team.

3 medication administration

Participants receive either metformin or colchicine as part of the trial. Both medications are administered orally.

The specific dosage and frequency of administration are determined by the trial protocol and communicated to participants at the start of this phase.

4 monitoring and assessments

Throughout the trial, participants undergo regular monitoring to assess their health-related quality of life (HRQoL) and other health parameters.

Primary assessments occur at 12 weeks, focusing on physical health using the Patient-Reported Outcomes Measurement Information System Profile29 (PROMIS-29).

5 secondary assessments

Secondary assessments at 12 weeks include mental health, fatigue, pain interference, and other domains using PROMIS-29 and additional questionnaires.

Adherence to the medication regimen is evaluated, and any adverse events are recorded and analyzed.

6 follow-up

A follow-up assessment is conducted 12 weeks after the cessation of medication use, totaling 24 weeks from the start of the trial.

This assessment evaluates the maintenance of treatment success in terms of HRQoL.

Who Can Join the Study?

  • Adults aged 18 years or older.
  • Living in the study area for the entire time they are part of the trial.
  • Having ongoing signs and symptoms of PASC (post-acute sequelae of SARS-CoV-2 infection), such as feeling very tired (fatigue) or feeling worse after physical or mental activity (PEM), for at least 12 weeks after getting a SARS-CoV-2 infection. These symptoms should not have been present before the infection, but they might have gotten better and then come back after the infection.
  • Being able to confirm they had a SARS-CoV-2 infection by one of the following:
    • A positive result from a nucleic acid amplification test (NAAT), like a PCR test.
    • A positive result from a rapid diagnostic test for SARS-CoV-2, including tests done at home.
    • A COVID-19 diagnosis made by a doctor, based on the tests mentioned above or other medical tests and evaluations.
  • Willing and able to give their agreement (informed consent) to participate in the trial.
  • Willing and able to follow the trial procedures.
  • Allowing their doctor or pharmacy and the trial team to share medical information that is important for their safety and the trial assessments.

Who Cannot Join the Study?

  • Individuals who have not experienced PASC, which stands for post-acute sequelae of SARS-CoV-2 infection. This refers to ongoing health issues that occur after recovering from the initial COVID-19 infection.
  • Individuals who are not within the specified age range for the study.
  • Individuals who do not meet the gender requirements for the study.
  • Individuals who are part of a vulnerable population that the study is not designed to include.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Universitair Medisch Centrum Utrecht Utrecht The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
10.02.2025

Trial locations

Investigated drugs:

Remdesivir is an antiviral medication that was originally developed to treat hepatitis C and later tested for Ebola. In this trial, it is being evaluated for its potential to improve physical health-related quality of life in patients experiencing long-term effects after a SARS-CoV-2 infection.

Dexamethasone is a corticosteroid that helps reduce inflammation in the body. It is commonly used to treat a variety of conditions, including severe allergies and asthma. In this trial, it is being studied for its effectiveness in improving the quality of life for patients with lingering symptoms after a COVID-19 infection.

Baricitinib is a medication that is typically used to treat rheumatoid arthritis by reducing inflammation and pain in the joints. In this study, it is being tested to see if it can help alleviate the long-term symptoms experienced by patients after recovering from COVID-19.

Tocilizumab is an immunosuppressive drug that is often used to treat rheumatoid arthritis by blocking a specific protein that causes inflammation. This trial is investigating its potential benefits for patients dealing with ongoing symptoms following a SARS-CoV-2 infection.

Investigated diseases:

Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) – This condition refers to a range of symptoms that persist after the acute phase of a COVID-19 infection has resolved. Individuals may experience ongoing fatigue, difficulty breathing, joint pain, and cognitive issues, often described as “brain fog.” Symptoms can vary widely among individuals and may affect multiple organ systems. The condition can develop weeks or even months after the initial infection, regardless of the severity of the acute illness. It is sometimes referred to as “long COVID” and can significantly impact daily functioning and quality of life. The exact cause of these prolonged symptoms is still under investigation.

Trial ID:
2024-511580-28-02
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A Study of Fluvoxamine for Reducing Fatigue in Patients with Post-COVID Condition

    Recruiting

    3 1 1
    Investigated diseases:
    The Netherlands

  • A Study of Sonlicromanol for Reducing Fatigue in Patients with Long COVID

    Recruiting

    2 1
    Investigated drugs:
    The Netherlands