Not yet recruiting

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.

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.
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).
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.
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).
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.
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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Verified sites

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Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands

Trial locations

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Investigated drugs

REGEN-COV
is a combination of two monoclonal antibodies, casirivimab and imdevimab, used to treat COVID-19. It works by helping the immune system fight the virus, potentially reducing the severity of the disease and improving recovery times.
Molnupiravir
is an antiviral medication that helps to stop the replication of the virus that causes COVID-19. It is used to treat mild to moderate COVID-19 in adults who are at risk of developing severe illness.
Baricitinib
is a medication that reduces inflammation by inhibiting certain enzymes in the body. It is used in the treatment of COVID-19 to help manage symptoms and improve outcomes in patients with severe cases.
Fluvoxamine
is an antidepressant that is being studied for its potential to reduce inflammation and improve outcomes in patients with COVID-19. It may help in managing symptoms and preventing the progression of the disease.

What is already known about the treatment

RECLAIM – This medication is currently being evaluated in clinical trials for its effectiveness in treating post-acute sequelae of SARS-CoV-2 infection (PASC). It is administered orally, allowing for easy application. The main therapeutic indication is to improve the physical health-related quality of life in patients who have recovered from COVID-19 but continue to experience lingering symptoms. The mechanism of action at the molecular level involves modulating immune responses and reducing inflammation, which may help alleviate persistent symptoms. It is classified pharmacologically as an investigational drug, as it is still under study to determine its full potential and safety profile.

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.