Active not recruitingPHASE2INTERVENTIONAL

Study to Investigate Improvement in Physical Function in SF-36 With Vericiguat Compared With Placebo in Participants With Post-COVID-19 Syndrome

This research study is looking into whether a medication called Vericiguat can ease the extreme tiredness and other problems some people experience after having COVID-19, often called 'Long COVID' or 'Post-COVID Syndrome.' Researchers want to see if Vericiguat can improve how well people can do daily activities. They will compare it to a 'dummy' pill (placebo) to understand its effects and identify any side effects. This study includes people aged 18 to 50 who were not hospitalised with COVID-19 but still have symptoms for at least six months. Participants will take a tablet daily for 10 weeks, and the study will last about 18 weeks in total.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Charite University, Berlin, Germany

Enrolment target

104

Start

22 Jun 2023

Estimated completion

31 Dec 2026

Post-COVID ME/CFS

What is this study about?

This research study, called a clinical trial, is investigating a new way to help people who are still suffering after having COVID-19. Many people experience ongoing problems like extreme tiredness (fatigue) that doesn't get better with rest, even months after feeling better from the initial infection. This is often known as Post-COVID Syndrome (PCS) or Long COVID, and sometimes it's like Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

The study aims to see if a medication called Vericiguat can improve how people feel and function. Vericiguat is a drug that's already approved for other conditions, but researchers believe it might help with Long COVID because it could improve blood flow in tiny blood vessels, which some scientists think might be a problem in people with ongoing COVID symptoms. Currently, there isn't a specific treatment for Long COVID, so finding effective therapies is very important.

Participants in this study will either receive Vericiguat or a dummy pill (placebo) for 10 weeks. This helps researchers fairly compare the effects of the drug. Everyone involved, including the patients and the medical staff, won't know who is getting the actual drug and who is getting the placebo until the end of the study. This helps ensure the results are as accurate as possible and not influenced by what people expect. The study will also carefully check for any side effects of Vericiguat.

Key takeaways

This study tests a drug called Vericiguat for Long COVID symptoms.
It focuses on improving physical function and easing fatigue.
Participants will take either Vericiguat or a dummy pill for 10 weeks.
The study aims to understand the drug's effects and identify side effects.
Eligibility includes adults 18-50 with Long COVID symptoms for at least 6 months.
Participation lasts about 18 weeks, with regular health checks.

Who may be eligible?

To be considered for this study, you would need to be an adult between 18 and 50 years old. You must have had a confirmed case of COVID-19 (not severe enough to require hospitalisation) and still be experiencing symptoms of Post-COVID Syndrome or Long COVID for at least six months. This includes having extreme tiredness that gets worse after even small efforts.

There are also some specific medical conditions and circumstances that would prevent you from joining. For example, if you've had a COVID-19 vaccination within the last four weeks, or if you had chronic fatigue syndrome or similar fatigue conditions before you got COVID-19, you wouldn't be able to participate. Also, women who could become pregnant would need to be using a reliable form of birth control.

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 between 18 and 50 years old?
Did you have COVID-19, but weren't hospitalised for it?
Have you had ongoing symptoms like extreme tiredness for at least 6 months since getting COVID-19?
Have you not had a COVID-19 vaccination in the last 4 weeks?
If you are a woman who could become pregnant, are you using a highly effective form of birth control?
Are you generally free from other serious health conditions that cause chronic fatigue?

Answer every question to see your result.

What does participation involve?

If you join this study, your participation will last for about 18 weeks in total. First, there will be a screening process that could last up to 28 days to make sure you meet all the requirements. After that, you will be randomly assigned to one of two groups: either you'll take the Vericiguat tablet or a matching dummy pill (placebo) once a day for 10 weeks.

The dosage of the tablet will gradually increase over the first four weeks, starting at a lower dose and slowly going up to the full dose, as long as it's safe for you. Neither you nor the study team will know if you're taking the real drug or the placebo. During this time, you'll have appointments to check your health, including your heart, and to monitor how you're feeling and any changes in your symptoms. After the 10 weeks of taking the tablets, there will be a follow-up period of 30 days to check on your health.

Potential risks and benefits

Taking part in this study could potentially offer some benefits, such as receiving a new treatment that might improve your Long COVID symptoms and physical function, or at least helping advance understanding of the condition. However, there's no guarantee that you will receive the active drug or that it will help you. Potential risks include experiencing side effects from Vericiguat, or from the assessments and procedures involved in the study. You will be closely monitored for any adverse reactions. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Charité - Universitätsmedizin Berlin
Verified postcode
Berlin, Germany

Common questions

What is Post-COVID Syndrome?

It's when people have lingering health problems like extreme tiredness, brain fog, and other symptoms for weeks or months after their initial COVID-19 infection.

What is Vericiguat?

It's a drug that's already approved for other conditions, and researchers are now testing if it can help improve blood flow in tiny vessels, which might reduce Long COVID symptoms.

What is a 'placebo'?

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

How long will the study last?

If you participate, the study will involve about 18 weeks in total, including screening, 10 weeks of taking tablets, and a 30-day follow-up.

Will I know if I'm getting the drug or the placebo?

No, neither you nor the doctors will know during the study. This is called 'blinding' and helps make the study results more reliable.