Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A parallel-group treatment, phase 2a, double-blind, placebo-controlled 2-arm study to show improvement of physical function in SF-36 (SF-36-PF) in participants treated with Vericiguat compared to placebo tablets participants with post-COVID-19 syndrome without (PCS) or with (PCS/CFS) fulfillment of ME/CFS criteria - VERI-LONG

This research study, called VERI-LONG, is exploring a new medication called Vericiguat for people who are still experiencing health problems after having COVID-19. This condition is often called 'Long COVID' or Post-COVID-19 Syndrome (PCS), and some people also meet the criteria for ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome). The main goal of the study is to see if Vericiguat can improve how well people can do physical activities. Participants will receive either the study drug or a placebo (a dummy pill) without knowing which one they have. Researchers will compare how participants’ physical function changes over 10 weeks to understand if Vericiguat could be a helpful treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Charite Universitaetsmedizin Berlin KöR

Enrolment target

104

Start

13 Nov 2024

Post-COVID-19 syndrome without (PCS) or with (PCS/CFS) fulfillment of myalgic encephalomyelitis/chronic fatique syndrome (ME/CFS) criteria

What is this study about?

This study, known as VERI-LONG, is investigating a new medicine called Vericiguat for individuals experiencing lasting health issues after a COVID-19 infection. These ongoing problems are commonly referred to as 'Long COVID' or Post-COVID-19 Syndrome (PCS). For some, these long-term symptoms might also fit the description of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, often shortened to ME/CFS.

The main purpose of this research is to see if Vericiguat can help improve your physical abilities and overall daily function. Researchers want to understand if taking this medicine makes a noticeable difference in how well people can move around and perform everyday tasks, compared to those who don't receive it. They will be particularly interested in changes observed over a period of 10 weeks.

To ensure fair testing, the study will compare Vericiguat with a 'dummy pill' (placebo). Neither you nor your study doctor will know whether you are receiving the active drug or the placebo. This helps prevent any bias when assessing the treatment's effects. The hope is that the results from this study will give us a clearer picture of whether Vericiguat could be a useful treatment option for people living with the challenges of Long COVID.

Key takeaways

This study investigates a new drug, Vericiguat, for Long COVID (Post-COVID-19 Syndrome).
It aims to see if the drug can improve physical activity and reduce fatigue.
Participants will receive either the active drug or a placebo (dummy pill).
The study measures changes in physical function over 10 weeks.
It includes people whose Long COVID symptoms also meet ME/CFS criteria.
Careful monitoring for side effects will be conducted.

Who may be eligible?

This study is looking for adults aged 18 and older. There is no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to participate.

To be eligible, you must have been diagnosed with Post-COVID-19 Syndrome (often called 'Long COVID'). This includes people whose symptoms also meet the criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

There might be other specific health requirements or conditions that could prevent someone from joining the study, which would be discussed in detail by the study team during a screening process.

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-19 Syndrome (Long COVID)?
Do your symptoms also fit the criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), or is it just Long COVID?
Are you willing to take study medication (or a placebo) for 10 weeks?
Are you able to attend regular clinic visits for assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to one of two groups: one receiving the active study drug (Vericiguat) and the other receiving a placebo (a dummy pill that looks exactly like the study drug but contains no active medicine). Neither you nor your study doctor will know which one you are receiving – this is called a 'double-blind' study and helps make the results fair and unbiased.

You would take either the study drug or placebo tablets as directed. Over the course of the study, you would have several visits to the study clinic. These visits will involve various assessments, including questionnaires about your physical function and how tired you feel. Your grip strength might also be measured. Researchers will carefully monitor you for any side effects from the medication. The main part of the study involves taking the medication for 10 weeks, with assessments regularly conducted during this period.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. You might benefit if the study drug, Vericiguat, helps improve your physical function or reduces your fatigue. However, because you might receive a placebo, there's no guarantee of direct benefit. There's always a risk of experiencing side effects from any medication, including the study drug. All potential side effects will be carefully monitored and explained to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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 'Long COVID'?

Long COVID, or Post-COVID-19 Syndrome, is a term for health problems that continue for weeks or months after the initial COVID-19 infection.

What is a placebo?

A placebo is a 'dummy pill' that looks exactly like the study drug but does not contain any active medicine. It helps compare the drug's effects fairly.

Why don't I know if I'm getting the drug or the placebo?

This is called a 'double-blind' study. It helps prevent any bias in the results, ensuring that neither you nor the doctors know who is getting which treatment until the study is over.

How long will I be taking part in the study?

The main treatment period for the study is 10 weeks, during which your physical function will be regularly assessed.

What is ME/CFS?

ME/CFS stands for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, a complex illness causing extreme fatigue, sleep problems, pain, and other symptoms that can worsen after physical or mental activity.