Study on the Effects of Vidofludimus Calcium for Patients with Post-COVID Syndrome

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What is this study about?

This clinical trial is focused on studying treatments for Post COVID Syndrome (PCS), a condition that some people experience after recovering from COVID-19. The trial will test a medication called IMU-838, which contains the active ingredient vidofludimus calcium. This medication is being evaluated to see if it can help reduce inflammation and improve the physical function of patients with PCS.

The purpose of the study is to compare the effects of IMU-838 with a control group on the overall physical function of patients by Day 56. Participants in the study will receive either the IMU-838 tablets or a placebo, which looks like the real medication but does not contain the active ingredient. The study will last for several weeks, during which participants will take the medication and have their physical and mental health monitored at different intervals.

Throughout the study, participants will be asked to report on their symptoms and any changes they experience. The trial aims to gather information on how IMU-838 affects symptoms like fatigue, cognitive impairment, and shortness of breath, which are common in PCS. By the end of the study, researchers hope to determine if IMU-838 can be an effective treatment option for those suffering from PCS.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Written informed consent is required, ensuring understanding and agreement to participate.

Eligibility is confirmed based on criteria such as age, symptoms of post-COVID syndrome, and ability to comply with trial procedures.

2 initial assessment

An initial assessment is conducted to establish a baseline for physical and mental health. This includes evaluations using the Short Form-36 Physical Function (SF-36-PF) and other relevant health questionnaires.

3 medication administration

The patient receives either the IMU-838 tablet or a placebo. The IMU-838 is administered orally in doses of 45 mg or 22.5 mg, depending on the study group assignment.

The medication is taken daily for the duration of the trial, which is up to 84 days.

4 ongoing assessments

Regular assessments are conducted to monitor changes in physical and mental health. These occur at specified intervals, such as Days 28, 56, and 84.

Assessments include measuring fatigue, cognitive function, and other symptoms using standardized questionnaires.

5 final evaluation

At the end of the trial period, a final evaluation is conducted to assess the overall impact of the treatment on physical function and other health parameters.

The results are compared to the initial baseline to determine any changes or improvements.

Who Can Join the Study?

Male or female patients who are at least 18 years old.
Use a highly effective method of birth control correctly and consistently during the trial and for 28 days after the last dose, if applicable.
Female patients who can have children must have a negative pregnancy test before starting the trial and agree not to become pregnant or donate eggs. They must use highly effective birth control methods.
Male patients must agree not to father a child or donate sperm from the start of the trial until 30 days after the last dose. They must either abstain from sex or use barrier contraception, and if their partner can become pregnant, she should use a highly effective contraceptive method. If their partner is pregnant, they must use condoms to avoid exposing the fetus to the trial medication.
Have symptoms consistent with Post Covid Syndrome (PCS) that started within 4 weeks of the initial COVID infection and have lasted for more than 12 weeks. These symptoms should not be due to other conditions or medications and should not have existed before the COVID infection.
Have moderate to severe overall disability, measured by a Bell Scale score between 20 and 60.
Have at least two of the following post-COVID symptoms:
- Fatigue, measured by an FSS score of 36 or higher.
- Cognitive impairment, measured by a MoCA score between 10 and 25.
- Shortness of breath, measured by an mMRC score of 2 or higher.
- Orthostatic/autonomic dysfunction, shown by:
  - A sustained heart rate increase of 30 beats per minute or more within 10 minutes of standing, or a heart rate reaching over 120 beats per minute within 10 minutes of standing.
  - No sustained drop of 20 mmHg in systolic blood pressure within 10 minutes of standing.
Provide written informed consent according to international guidelines and local laws.
Be able to understand the trial and follow the trial procedures.
Be able to use a smartphone, tablet, or other device to download and install the medical device software used in the trial.
Agree not to connect medical devices used in the trial to any other app not defined in the trial protocol, especially not to Garmin Connect.
Agree not to change the type, dosage, and frequency of other medications through Day 84 of the trial.

Who Cannot Join the Study?

Patients who are currently pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to any of the study medications are excluded.
Patients with significant liver or kidney disease are not eligible.
Those who have participated in another clinical trial within the last 30 days cannot join.
Individuals with a history of drug or alcohol abuse in the past year are excluded.
Patients with any other serious medical condition that might interfere with the study are not eligible.
Anyone who is unable to comply with the study procedures or follow-up visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Medicine Greifswald	Greifswald	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Kflqdzil Lgimu Grhz	Detmold	Germany
Uxmevnoicm Hoepfarv Ckclkex	Cologne	Germany
Glbzxa Ugtegmxxbz Fgwjcgvti	Frankfurt	Germany
Krydgweo dvi Urohoponsvsa Mhevevqs Alr	Munich	Germany
Ujbgbiwlpcsavvimlunhs Wlvjkmxuk Arx	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.07.2024

Trial locations

Investigated drugs:

Vidofludimus Calcium

IMU-838 is a medication being studied for its potential to reduce inflammation in patients experiencing post-COVID syndrome. The trial aims to assess how this medication affects the overall physical function of patients over a period of 56 days. IMU-838 is being compared to a control group to determine its effectiveness in improving symptoms associated with post-COVID syndrome.

Post-COVID Syndrome – This condition occurs in individuals who have recovered from the acute phase of COVID-19 but continue to experience symptoms. It can affect multiple organ systems and lead to a variety of symptoms such as fatigue, shortness of breath, and cognitive difficulties. The symptoms can vary widely among individuals and may persist for weeks or months. Patients often report a decline in physical and mental health, impacting their daily activities and quality of life. The syndrome is characterized by a fluctuating course, with symptoms that can improve and then worsen again. It is still being studied to understand its full impact and progression.

Trial ID:

2024-511628-16-00

Protocol code:

2023-02978

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Vidofludimus Calcium for Patients with Post-COVID Syndrome

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?