Study of Vericiguat to improve physical function in patients with Post-COVID-19 syndrome with or without chronic fatigue syndrome

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What is this study about?

This clinical trial focuses on Post-COVID-19 syndrome (PCS), a condition that occurs after COVID-19 infection, including cases where patients develop myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The study aims to evaluate if a medication called Vericiguat (also known as MK-1242) can improve physical function in people with these conditions.

The study will test different doses of Vericiguat tablets compared to placebo in adults who have been experiencing post-COVID symptoms for 6 months or longer. Participants will take the medication orally, with doses ranging from 2.5 mg to 10 mg per day. The treatment period will last for 10 weeks.

During the study, researchers will measure changes in physical function using a standardized health survey. They will also monitor other aspects of health, including fatigue levels and muscle strength. The study will track any side effects that participants may experience during the treatment period.

1 Initial evaluation

Your eligibility for the study will be assessed based on age (18-55 years) and confirmed mild to moderate COVID-19 history

The evaluation includes checking for ongoing symptoms lasting 6 months or more

Medical tests will be performed to check thyroid function and measure specific health indicators

2 Treatment assignment

You will be randomly assigned to receive either Vericiguat tablets or placebo tablets

The study is double-blind, meaning neither you nor the study staff will know which treatment you receive

3 Treatment period

The treatment period lasts for 10 weeks

You will take the assigned medication orally (by mouth)

The medication comes in tablet form in different strengths (2.5 mg, 5 mg, or 10 mg)

4 Monitoring and assessments

Your physical function will be measured using a standardized questionnaire (SF-36-PF)

Additional assessments include:

– Measurement of hand grip strength

– Evaluation of fatigue levels

– Monitoring for any side effects or health changes

5 Final evaluation

After 10 weeks, final assessments will be conducted to measure changes in your physical function

The results will be compared to your initial measurements to evaluate the treatment effectiveness

Who Can Join the Study?

Age between 18-55 years old (for women over 50, must have regular menstrual cycles or specific hormone levels)
Confirmed mild to moderate COVID-19 case through PCR test or blood antibody test, not requiring hospitalization
Experiencing symptoms for at least 6 months after COVID-19 infection
Have a Bell Score between 30-60 (a scale measuring functional ability and severity of symptoms)
Show signs of blood vessel function problems through specific medical tests
Have normal thyroid function
Able to understand and willing to provide informed consent
Must sign informed consent before starting any study procedures
For women who can become pregnant:
- Must have a negative pregnancy test before starting the study
- Must use highly effective birth control methods (such as hormonal contraception, IUD, or other approved methods)
For women who have gone through menopause: Must not have had menstrual periods for at least 12 months

Who Cannot Join the Study?

Age below 18 years or above 65 years
Pregnancy or breastfeeding
History of severe allergic reactions to medications
Participation in other clinical trials within the past 30 days
Severe heart conditions (such as uncontrolled high blood pressure or recent heart attack)
Severe kidney or liver problems
Active infections requiring treatment
History of blood clotting disorders
Mental health conditions that could affect study participation
Use of medications that could interact with the study drug
Unable to provide informed consent
Inability to follow study procedures or attend scheduled visits
History of drug or alcohol abuse within the past year
Major surgery within the past 3 months
Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	22.06.2023

Trial locations

Investigated drugs:

Vericiguat

Vericiguat is a medication that helps improve physical function in people who have post-COVID-19 syndrome. It works by stimulating an enzyme in the body that helps blood vessels relax and improves blood flow. This medication is being studied to see if it can help people who are experiencing ongoing symptoms after COVID-19 infection, including those who may have developed chronic fatigue syndrome (ME/CFS). The medication is taken in tablet form.

Post-COVID-19 syndrome (PCS) – A condition that develops following COVID-19 infection, where symptoms persist beyond 12 weeks after the initial infection. The syndrome can include ongoing fatigue, shortness of breath, cognitive problems (brain fog), muscle aches, and various other symptoms that impact daily activities. Some patients may experience fluctuating symptoms that can worsen after physical or mental effort.

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) – A complex, long-term illness characterized by severe fatigue that doesn’t improve with rest and worsens with physical or mental activity. The condition includes symptoms such as unrefreshing sleep, cognitive difficulties, muscle pain, and post-exertional malaise. People with ME/CFS often experience profound fatigue that interferes with daily activities. The condition can develop suddenly or gradually, with symptoms varying in intensity over time.

Trial ID:

2024-517713-33-00

Protocol code:

VERI-LONG

NCT ID:

NCT05697640

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Vericiguat to improve physical function in patients with Post-COVID-19 syndrome with or without chronic fatigue syndrome

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?