Study of Plitidepsin Treatment for Adults with Post-COVID-19 Condition

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What is this study about?

This clinical trial focuses on studying Post-COVID-19 Condition (also known as Long COVID), a condition where symptoms persist or develop after the initial COVID-19 infection. The study will evaluate a medication called plitidepsin, which will be given through intravenous infusion. Some participants will receive a placebo instead of the active treatment. The purpose is to determine if plitidepsin is effective and safe for treating adults with Post-COVID-19 Condition.

During the study, participants will receive either plitidepsin or placebo along with several supportive medications including palonosetron, famotidine, dexamethasone phosphate, and dexchlorpheniramine. These additional medications help manage potential side effects of the treatment. The study will last for 90 days after treatment, during which participants’ overall health and symptoms will be monitored.

Throughout the study, various aspects of participants’ health will be evaluated, including physical activity levels, mental health, sleep quality, and general well-being. The researchers will also examine blood samples to study changes in inflammation markers and immune system responses. This comprehensive approach will help determine how well the treatment works for people with Post-COVID-19 Condition.

1 Initial treatment phase

You will receive either plitidepsin or a placebo (inactive substance) through an intravenous infusion

Before the infusion, you will receive preventive medications:

– Palonosetron (given through intravenous injection)

– Famotidine (taken by mouth)

– Dexamethasone phosphate (given through intravenous injection)

– Dexchlorpheniramine (given through intravenous injection)

2 First follow-up visit

Visit occurs on day 10 (plus or minus 2 days)

Your overall health will be evaluated using various questionnaires

Physical activity tests will be performed

Blood samples will be collected to check inflammation markers and other health indicators

A stool sample will be collected to analyze intestinal microbiota

3 Second follow-up visit

Visit occurs on day 30 (plus or minus 2 days)

Similar evaluations as the first follow-up visit will be performed

Your physical and mental health will be assessed through questionnaires

Additional blood and stool samples will be collected

4 Final follow-up visit

Visit occurs on day 90 (plus or minus 5 days)

Final comprehensive health assessment will be conducted

All questionnaires will be completed again

Final blood and stool samples will be collected

Your overall progress will be evaluated comparing all results from previous visits

Who Can Join the Study?

Age requirement: Must be 18 years or older, both men and women can participate
Must have documented evidence of previous SARS-CoV-2 infection at least 90 days before study entry through one of these tests:
- Positive PCR test (a laboratory test that detects viral genetic material)
- Positive rapid antigen test (a quick test that detects virus proteins)
- Positive blood test showing antibodies against the virus
Must have at least 3 symptoms affecting at least two different body systems that:
- Have lasted for at least 2 months
- Started at least 90 days after COVID-19 infection
- Cannot be explained by another medical condition
Must have significant limitations in performing regular daily activities
Must be willing to follow study requirements and attend all scheduled follow-up visits
Must be able to understand study information and provide informed consent

Who Cannot Join the Study?

Age below 18 years or above 65 years
Inability to provide informed consent
Presence of severe mental health conditions that could interfere with study participation
Current participation in other clinical trials
Pregnancy or breastfeeding
Active cancer treatment
Severe heart, kidney, or liver disease
Uncontrolled diabetes (high blood sugar levels)
History of organ transplantation
Severe respiratory conditions requiring oxygen therapy
Major surgery within the past 3 months
Unable to complete questionnaires or follow study procedures
Unstable medical conditions requiring frequent hospitalization
Current substance abuse or dependence
Use of medications that could interfere with study results

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hdinbowr Uzngclusndccn Hlluknwm Tlqoi y Pkqtmd Imdbzgkz Csmukh dhnowbioepbhigknw (uysn	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.12.2024

Trial locations

Investigated drugs:

Plitidepsin is a medication originally derived from a marine organism. It is being studied as a potential treatment for Post-COVID-19 Condition (also known as Long COVID). The medication works by targeting certain cellular processes that may be involved in the persistence of COVID-19 symptoms. This treatment is being tested to see if it can help improve the overall health and quality of life of people who continue to experience symptoms after their initial COVID-19 infection.

Post-COVID-19 Condition (PCC) – A complex health condition that develops following COVID-19 infection, characterized by persistent symptoms lasting at least two months. The condition typically involves multiple body systems and can include ongoing fatigue, shortness of breath, cognitive difficulties (often called “brain fog”), muscle weakness, and various other symptoms. PCC can affect daily activities and quality of life, with symptoms that may fluctuate in intensity over time. The condition can occur regardless of the initial severity of COVID-19 infection, affecting both those who had mild and severe cases.

Trial ID:

2024-516378-31-00

Protocol code:

THALASSA 2.0

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Plitidepsin Treatment for Adults with Post-COVID-19 Condition

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?