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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

16 criteria

  • 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 trial?

7 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

IMU-838 – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential use in treating Post Covid Syndrome (PCS). The main therapeutic indication for IMU-838 is to reduce inflammatory activity in patients suffering from PCS. At the molecular level, IMU-838 works by inhibiting a specific enzyme involved in the immune response, which helps to decrease inflammation. It is classified as an immunomodulatory drug, which means it helps to regulate the immune system's activity.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511628-16-00Protocol code2023-02978Estimated enrolment376 patientsSponsorGoethe University Frankfurt

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