Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Investigation of pregabalin therapy and complex rehabilitation in treating chronic fatigue associated with post-COVID syndrome

This study aims to understand if a medication named Preato (75mg tablets) alongside a special rehabilitation programme can help people in the UK who are experiencing ongoing, severe tiredness (also known as chronic fatigue) after recovering from COVID-19. Participants will either receive Preato or a dummy pill (placebo), along with rehabilitation. Researchers want to see if this treatment can reduce fatigue and improve how far people can walk over a six-month period. They will also look at how it affects mood, anxiety, and overall satisfaction with life. Anyone aged 18 or older can potentially take part if they meet other health requirements.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher

Enrolment target

132

Start

31 Oct 2024

Chronic fatigue syndrome associated with post-COVID syndrome

What is this study about?

This study is designed to explore new ways to help people in the UK who are struggling with long-term tiredness, often called chronic fatigue, that started after they had COVID-19. Many people find this type of fatigue makes everyday life very difficult. The main goal is to see if a medication called Preato, used together with a specialised exercise and recovery programme, can make a real difference in reducing this tiredness.

Researchers will carefully measure changes in how tired people feel and how well they can walk over a period of three and six months. They'll use special questionnaires to track fatigue levels and a basic walking test. By comparing results from those who receive Preato and those who receive a dummy pill (placebo) – both combined with rehabilitation – they hope to learn if Preato is an effective part of treatment.

Beyond just tackling tiredness and walking ability, the study will also look at other important aspects of health that can be affected by chronic fatigue. This includes checking for changes in mood, how anxious people feel, their overall satisfaction with life, and how well they are coping with their condition. This will give a more complete picture of how the treatment might help people feel better.

Key takeaways

The study investigates Preato medication and rehabilitation for post-COVID chronic fatigue.
It aims to reduce tiredness and improve physical ability (walking).
Looks at effects on mood, anxiety, and general well-being too.
Participation involves taking tablets and a rehabilitation programme for six months.
Open to adults aged 18 and over who have post-COVID fatigue.
You might receive the active drug or a dummy pill.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. Both men and women are welcome to take part.

The study is specifically for individuals in the UK who are experiencing chronic fatigue that began after they had COVID-19. This means you would have ongoing, severe tiredness that significantly impacts your daily life.

Further checks will be done by the study team to make sure it's safe and appropriate for you to participate, based on your specific health history and current medications.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you experiencing long-lasting, severe tiredness that began after you had COVID-19?
Are you willing to take a study medication (either active drug or placebo) every day?
Are you able to attend regular appointments and complete assessments over six months?
Are you able to participate in a rehabilitation programme?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will either receive Preato tablets (75mg) or a dummy pill (placebo) – you won't know which one you're getting. Both groups will also take part in a special exercise and recovery programme. You would attend regular appointments over a six-month period, where researchers will assess your tiredness using questionnaires and ask you to do a walking test.

These assessments will happen at the start of the study, and then again after three months and six months. They will also involve answering questions about your mood, anxiety levels, and how satisfied you are with your life. The total duration of your active participation in the study would be six months.

Potential risks and benefits

Taking part in this study might offer some potential benefits, such as potentially experiencing reduced fatigue and improved walking ability if the treatments are effective. You would also receive close medical monitoring and contribute to scientific knowledge that could help others with post-COVID fatigue in the future. However, there's no guarantee of personal benefit, and you might receive the placebo. Potential risks could include side effects from the medication (Preato, like all medicines, can have side effects, which the study team would explain fully) or discomfort from the assessments. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland

Common questions

What is 'chronic fatigue associated with post-COVID syndrome'?

This means you have severe, long-lasting tiredness that started after you had COVID-19 and significantly affects your daily life.

What is Preato?

Preato is a medication (75mg tablets) that is being investigated in this study to see if it can help reduce chronic fatigue.

What is a 'placebo'?

A placebo is a dummy pill that looks just like the real medicine but contains no active ingredients. It helps researchers fairly compare the effects of the actual drug.

How long will the study last if I take part?

Your active participation in the study would last for six months, with assessments at the beginning, three months, and six months.

Will I know if I'm getting the drug or the dummy pill?

No, this is a 'blinded' study, meaning neither you nor the study team will know whether you are receiving Preato or the placebo until after the study is complete.