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Study on the Effects of Plitidepsin for Adults with Long COVID Symptoms

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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 the effects of a medication called Plitidepsin in adults who are experiencing a condition known as Post COVID-19. This condition can occur after recovering from a COVID-19 infection and may involve symptoms affecting multiple organs, lasting for at least two months. The purpose of the study is to evaluate how well Plitidepsin can improve the functional status of individuals with this condition.

Participants in the study will receive either Plitidepsin or a placebo, which is a substance with no active medication. The study will compare the effects of Plitidepsin to the placebo to see if there is an improvement in the participants' ability to perform daily activities. The study will also monitor any side effects that may occur. Other medications involved in the study include Famotidine, Dexamethasone Phosphate, Dexchlorpheniramine, and Palonosetron, which are used for various supportive treatments such as managing nausea, vomiting, and allergic reactions.

The study will take place over a period of time, with participants receiving treatments and being monitored for changes in their condition. The goal is to see if there is an improvement in symptoms and overall quality of life. Participants will be assessed at different intervals to track their progress and any changes in their health status. The study aims to provide valuable information on the potential benefits of Plitidepsin for those suffering from Post COVID-19 condition.

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

    Initial visit

    Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria, such as age and previous COVID-19 infection.

    Informed consent is obtained, ensuring understanding of the study's purpose and procedures.

  2. Step 2

    First infusion

    The first administration of the study medication occurs. This involves receiving an intravenous infusion of either plitidepsin or a placebo.

    The dosage of plitidepsin is 2.5 mg, administered through a vein.

  3. Step 3

    Monitoring period

    After the infusion, monitoring for any immediate reactions or side effects is conducted.

    Regular assessments are scheduled to evaluate changes in functional status and quality of life.

  4. Step 4

    Follow-up assessments

    Follow-up assessments are conducted at approximately 10, 28, and 90 days after the infusion.

    These assessments include evaluating functional status, quality of life, and any adverse events.

  5. Step 5

    Final evaluation

    A final evaluation is conducted to assess overall improvement and gather data on the study's outcomes.

    This includes a comprehensive review of all collected data and any changes in health status.

Who can join the trial?

8 criteria

  • Must be a male or female who is 18 years old or older.
  • Must have had a SARS-CoV-2 infection at least 90 days before joining the study. This can be shown by:
    • A positive result from a nasopharyngeal SARS-CoV-2 nucleic acid test like PCR or TMA.
    • A positive result from a nasopharyngeal rapid antigen test (RAT).
    • A positive result from a serology test against the SARS-CoV-2 N protein, regardless of vaccination status.
    • Must have symptoms of Post COVID-19 Condition (PCC) affecting at least two organs, lasting for at least 2 months and starting at least 90 days after the initial infection. These symptoms should not be explained by another diagnosis.
    • Must be unable to perform all usual duties or activities, which is defined as grades 3 or 4 in the Post-COVID Functional Status (PCFS) scale.
    • Must be willing to follow the study requirements and be available for follow-up during the study period.
    • Must have understood the information provided and be capable of giving informed consent.

Who cannot join the trial?

8 criteria

  • Patients who are currently experiencing a severe illness or medical condition that requires immediate treatment cannot participate.
  • Patients who have a history of severe allergic reactions to any of the ingredients in the study medication cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have a history of substance abuse or alcohol dependency cannot participate.
  • Patients who have a mental health condition that might interfere with their ability to follow the study procedures cannot participate.
  • Patients who have a medical condition that the study doctors believe might interfere with the study results cannot participate.
  • Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate, cannot participate.
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Investigated drugs

Plitidepsin is a medication being studied for its potential to help people who are experiencing ongoing symptoms after recovering from COVID-19, a condition often referred to as post COVID-19 condition or long COVID. This medication is being tested to see if it can improve the overall functional status of these patients, which means helping them feel better and perform daily activities more easily. The study aims to determine if plitidepsin can provide relief from the lingering effects of COVID-19, such as fatigue, difficulty concentrating, and other persistent symptoms.

What is already known about the treatment

Plitidepsin – Plitidepsin is administered as an injection, typically given by a healthcare professional. It is currently being studied in clinical trials for its potential use in treating post COVID-19 condition, which refers to lingering symptoms experienced after recovering from the initial COVID-19 infection. The main therapeutic goal of plitidepsin is to improve the functional status of individuals suffering from these persistent symptoms. At the molecular level, plitidepsin works by interfering with certain proteins in cells that are involved in the replication of viruses, thereby helping to reduce viral activity. It is classified as an antiviral medication.

Investigated diseases

Post COVID-19 Condition – This condition, also known as Long COVID, 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 wide range of symptoms, including fatigue, shortness of breath, and cognitive difficulties. The progression of Post COVID-19 Condition is variable, with some individuals experiencing symptoms that persist for weeks or months. The severity and combination of symptoms can fluctuate over time. It is characterized by a prolonged recovery period, where individuals may experience a gradual improvement or, in some cases, a worsening of symptoms. The condition can significantly impact daily functioning and quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504087-42-00Protocol codeTHALASAEstimated enrolment260 patientsSponsorFundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La Ciencia

sourced from the EU Clinical Trials Register and site verification

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