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Study on Metformin and Colchicine for Treating Long COVID Symptoms in Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of treatments for Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), which refers to the lingering symptoms some people experience after recovering from COVID-19. The trial will evaluate 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 affect the physical health-related quality of life in people with PASC. Participants in the study will receive either metformin, colchicine, or a placebo. The study will last for a total of 12 weeks, during which participants will take the medication in tablet form by mouth. The trial 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 impact of the treatments on various aspects of health, including physical function, fatigue, and mental health. The goal is to determine if these medications can help improve the quality of life for those experiencing ongoing symptoms after a COVID-19 infection. The study will also look at how well participants adhere to the treatment plan and any side effects they may experience.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, residence, and symptoms related to post-acute sequelae of SARS-CoV-2 infection (PASC).

    Informed consent is provided electronically, and permission is granted for the exchange of relevant medical information.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate physical health-related quality of life using the Patient-Reported Outcomes Measurement Information System Profile29 (PROMIS-29).

  3. Step 3

    Medication administration

    Participants receive either metformin or colchicine orally. The specific dosage and frequency are determined by the trial protocol.

    The medication is administered for a period of 12 weeks.

  4. Step 4

    Ongoing assessments

    Throughout the 12-week period, assessments are conducted to monitor physical and mental health, including fatigue, pain, depressive symptoms, anxiety, and sleep disturbance.

    Additional assessments include the Checklist Individual Strength (CIS-20R) and the DePaul Symptom Questionnaire (DSQ-2).

  5. Step 5

    End of medication period

    At the end of the 12-week medication period, a final assessment is conducted to evaluate the impact on health-related quality of life.

    The frequency and severity of any side effects are also recorded.

  6. Step 6

    Follow-up period

    A follow-up period of 12 weeks occurs after the cessation of medication to assess the maintenance of treatment success.

    Participants' adherence to the medication regimen is evaluated.

Who can join the trial?

9 criteria

  • Adults aged 18 years or older.
  • Living in the study area for the entire time of the trial.
  • Having ongoing signs and symptoms of PASC (post-acute sequelae of SARS-CoV-2 infection), such as tiredness or PEM (post-exertional malaise), for at least 12 weeks after getting a SARS-CoV-2 infection. These symptoms were not there before the infection but may have lessened and then returned after the infection.
  • Self-reported proof of having had a SARS-CoV-2 infection by one of the following:
    • A positive result from a SARS-CoV-2 nucleic acid amplification test, like a PCR test.
    • A positive result from a SARS-CoV-2 rapid diagnostic test, including tests done at home.
    • A COVID-19 diagnosis by a doctor, based on the above tests or other medical evaluations.
    • Willing and able to give informed consent electronically.
    • 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 trial evaluations.

Who cannot join the trial?

8 criteria

  • Individuals who have not experienced PASC, which stands for post-acute sequelae of SARS-CoV-2 infection. This means ongoing symptoms after recovering from COVID-19.
  • Individuals who are not within the specified age range for the study.
  • Individuals who do not meet the specific health conditions required for the study.
  • Individuals who are not able to provide informed consent, meaning they cannot understand and agree to the study's requirements.
  • Individuals who are pregnant or breastfeeding, as the study may not be safe for them.
  • Individuals who are participating in another clinical trial, as this could affect the study results.
  • Individuals with certain medical conditions that could interfere with the study or put them at risk.
  • Individuals who have a history of substance abuse, which could affect their ability to participate in the study.
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Investigated drugs

  • Metformin

    is a medicine that has been used for decades in the treatment of type 2 diabetes. It lowers blood sugar levels, improves metabolism and also appears to have a beneficial effect on inflammatory processes in the body. In this trial, metformin is taken by mouth as a tablet to determine whether it can reduce the long-lasting symptoms that follow a coronavirus infection, also known as long COVID, and thereby improve physical quality of life.

  • Colchicine

    is an anti-inflammatory medicine traditionally used for gout and certain inflammations of the sac around the heart. It curbs the activity of inflammatory cells and can thereby dampen persistent inflammatory reactions in the body. In this trial, colchicine is taken by mouth as a tablet to find out whether it can relieve the persisting symptoms after a COVID-19 infection and improve daily functioning.

What is already known about the treatment

  • Metformin

    Metformin is an oral medication taken as tablets that has been used for decades as the first-choice treatment for type 2 diabetes. It belongs to the biguanide class and works mainly by reducing sugar production in the liver and increasing the cells' sensitivity to insulin, effects linked to the activation of an enzyme called AMP kinase, which regulates the cells' energy metabolism. It is a safe, affordable and very well studied medicine, and recent research also suggests possible anti-inflammatory and antiviral effects. In this study, metformin is being tested to see whether it can relieve the persistent symptoms that follow SARS-CoV-2 infection, known as post-COVID syndrome.

  • Colchicine

    Colchicine is an oral anti-inflammatory medication, originally obtained from a plant called autumn crocus and used for a very long time to treat gout and pericarditis (inflammation of the sac surrounding the heart). It works by blocking microtubules, structures inside cells, which prevents inflammatory cells from moving and becoming activated, thereby reducing inflammation in the body. Because of its general anti-inflammatory effect, it is being studied more and more intensively in cardiovascular diseases and viral infections. In this study, colchicine is being evaluated as a possible treatment for the long-lasting symptoms that appear after 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 concentrating, and muscle pain. Some may also report shortness of breath, sleep disturbances, and mood changes. These symptoms can vary widely in intensity and duration among different individuals. The condition is often referred to as "long COVID" and can affect multiple organ systems. The exact cause of these prolonged symptoms is still under investigation.
Trial detailsLast updated 30 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511580-28-00Estimated enrolment1 500 patientsSponsorUniversitair Medisch Centrum Utrecht

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