Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Randomized adaptive assessment of post COVID syndrome treatments (RAPID) Reducing Inflammatory Activity in Patients with post COVID Syndrome (REVIVE)

This research, known as the REVIVE study, is focused on finding better treatments for Post-COVID Syndrome, sometimes called long COVID. Many people continue to experience symptoms like extreme tiredness, breathlessness, and brain fog long after their initial COVID-19 infection. This study will carefully test a new medicine called IMU-838. Participants will receive either a placebo (a dummy pill with no medicine) or one of two different strengths of IMU-838. The main goal is to see if this medicine can improve physical function – how well people can do everyday activities – over roughly eight weeks. We also want to understand its effects on fatigue, mental well-being, thinking skills, and other common long COVID symptoms.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Goethe University Frankfurt

Enrolment target

376

Start

31 May 2024

Post Covid Syndrome (PCS)

What is this study about?

Many people who have had COVID-19 find themselves still feeling unwell weeks or even months later. This is often called Post-COVID Syndrome, or long COVID. Symptoms can be wide-ranging, from constant tiredness and breathlessness to problems with memory and concentration. Living with these ongoing symptoms can be really tough, affecting daily life, work, and overall well-being.

This study, called REVIVE, is an important step in trying to find effective treatments for long COVID. We know that inflammation in the body might play a role in why people feel unwell for so long. The medicine being tested, IMU-838, is thought to work by reducing this inflammation. By taking part, you could help doctors understand if this new medicine can make a real difference to people's lives.

The study is designed to be very thorough. We'll be looking closely at how people's physical abilities change over time, but also at other key areas like fatigue levels, mental health, and thinking skills. This information will help us figure out if IMU-838 is a safe and helpful option for people with long COVID.

Key takeaways

This study is testing a new medicine (IMU-838) for long COVID.
It aims to reduce inflammation and improve physical well-being.
Participants will receive either the medicine or a placebo (dummy pill).
The study measures changes in physical function, fatigue, and mental health.
Participation involves regular clinic visits and health assessments over about 12 weeks.
You can stop participating in the study at any time.

Who may be eligible?

This study is looking for adults aged 18 and over who are currently experiencing Post-COVID Syndrome. There's no upper age limit, so people of all adult ages can be considered.

The study is open to both men and women. Your doctor will need to check your full medical history and current health to make sure that taking part in this specific study would be safe and appropriate for you.

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?
Have you been diagnosed with Post-COVID Syndrome (long COVID)?
Are you able to attend regular clinic appointments for about 12 weeks?
Are you comfortable filling out questionnaires about your health and symptoms?
Is your doctor aware of your interest in clinical research?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either a placebo (a dummy pill with no medicine) or one of two different doses of the medicine IMU-838 – you wouldn't know which one. You would take these tablets regularly as instructed. There will be several visits to the study clinic over a period of about 12 weeks. During these visits, the study team will carry out health checks, ask you about your symptoms, and you'll complete questionnaires to track things like your physical ability, tiredness, and mood. We'll also assess your thinking skills, breathing, and how your body reacts to exercise. Some assessments might involve using small devices to monitor your activity and heart rate over a few days. The total duration of active participation in the study is about 12 weeks, with follow-up on your progress after that.

Potential risks and benefits

Taking part in a research study like REVIVE could offer you access to a new experimental treatment for long COVID that is not yet widely available. Your health will be closely monitored by a healthcare team throughout the study. However, like all medicines, IMU-838 may have side effects, and some participants will receive a placebo which doesn't contain active medicine. Your condition might improve, stay the same, or even worsen. You are 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
Germany

Common questions

What is Post-COVID Syndrome?

Post-COVID Syndrome (or long COVID) is when you continue to have symptoms for weeks or months after being infected with the COVID-19 virus.

What is a placebo?

A placebo is a 'dummy pill' that looks exactly like the real medicine but contains no active ingredients. It helps us see if the medicine really works, rather than just the idea of taking medicine.

How long will the study last for me?

If you join, your active participation in the study will last for about 12 weeks, with some follow-up after that.

Will I know if I'm getting the real medicine?

No, this is a 'blinded' study, meaning neither you nor the study team will know whether you are receiving the active medicine or the placebo until the study is over.

What does 'physical function' mean in the study?

Physical function refers to your ability to do everyday tasks and activities, like walking, dressing, or running errands, and how well your body moves and works.