Phase II proof-of-concept, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of plitidepsin in adults with post-COVID-19 Condition (PCC)
Long COVID, also known as post-COVID-19 condition, causes lasting problems such as severe tiredness, brain fog, and muscle aches that continue months after an infection. This Phase II study is testing whether an antiviral drug called plitidepsin can help people recover. Half of the participants receive plitidepsin, while the other half receive a dummy medicine (placebo). Because the study drug can cause mild reactions or sickness, everyone also receives standard supportive medicines, including antihistamines and anti-sickness tablets, to keep them comfortable. Over roughly 90 days, doctors will track changes in participants' physical energy, memory, sleep, and overall quality of life using questionnaires, movement tests, and blood checks. The trial aims to find out if plitidepsin works well and is safe for the heart and liver.
At a glance
What is this study about?
Most people recover from COVID-19 within a few weeks, but some experience symptoms that last for months or even years. This is commonly known as long COVID or post-COVID-19 condition. It can cause profound exhaustion, breathlessness, joint pain, low mood, and trouble concentrating, often making normal daily life very difficult. Currently, doctors have very few targeted treatments to offer for this condition.
This trial is testing an experimental medicine called plitidepsin to see if it can help adults recover their health. Scientists believe that ongoing COVID symptoms might be driven by tiny amounts of virus remaining in the body or by long-lasting inflammation. Plitidepsin is designed to tackle these underlying issues. The study is 'double-blind', meaning neither you nor your study doctor will know whether you are receiving plitidepsin or the inactive dummy medicine (placebo). This ensures the results are completely fair and unbiased.
To ensure participant safety, the study includes protective medicines given alongside the treatment. These include common medicines like steroids, anti-sickness tablets, and allergy medicines that help prevent infusion reactions or nausea. Doctors will keep a very close eye on your health throughout the trial, particularly checking how your heart and liver respond.
Finding a treatment that helps people with long COVID regain their energy and mental clarity is an urgent priority. Even if plitidepsin does not work for everyone, the information gathered from this study will provide vital clues for future research and care.
Key takeaways
- Tests whether the drug plitidepsin can ease long COVID symptoms.
- Open to adults aged 18 and over with post-COVID-19 condition.
- Participants are randomly assigned to receive either plitidepsin or a placebo.
- Includes supportive medicines to reduce nausea and allergic reactions.
- Involves health checks, blood tests, and surveys over a 90-day follow-up period.
- Participation is completely voluntary and you can withdraw at any time.
Who may be eligible?
This study is open to adults aged 18 and older of any gender who have ongoing symptoms after a COVID-19 infection. Your symptoms should fit the standard definition of post-COVID-19 condition, meaning they have lingered and continue to affect your day-to-day life.
To take part, you must be able to attend clinic appointments, complete questionnaires about how you feel, and receive medication through a drip into a vein.
Certain people will not be able to join for safety reasons. For example, if you have severe pre-existing heart or liver disease, or if you take medicines that could interact badly with the trial drugs, this study may not be suitable for you. The study doctors will review your medical history and carry out simple health checks before you join to ensure it is safe.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am at least 18 years old.
- I have lingering health symptoms that began after a COVID-19 infection.
- My symptoms affect my everyday wellbeing, energy, or concentration.
- I am comfortable receiving medicine through a drip in a vein.
- I can attend hospital or clinic visits over a 3-month period.
What does participation involve?
Taking part involves receiving the study treatment through an intravenous drip (into a vein) alongside supportive medicines to prevent sickness or allergic reactions. You will be followed up closely for about 90 days (roughly three months). During this time, you will visit the study clinic for check-ups around Day 10, Day 30, and Day 90. At these visits, doctors will check your vital signs, take blood samples to monitor inflammation and organ health, and ask you to complete surveys about your energy, mood, and sleep. You may also do simple physical checks, like a test counting how many times you can stand up from a chair. The entire study lasts about three months from your first dose.
Potential risks and benefits
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Common questions
What is plitidepsin?
Plitidepsin is an antiviral medicine that scientists hope will help clear lingering traces of the virus and calm long-term inflammation in people with long COVID.
What is a placebo?
A placebo is a dummy treatment that looks identical to the real medicine but contains no active drug. It allows researchers to see if changes in health are truly caused by plitidepsin.
Why do I need to take other medicines during the trial?
You will be given standard medicines like antihistamines and anti-sickness tablets before the infusion to protect you against nausea and mild allergic reactions.
Will taking part cost me any money?
No, all study medicines, tests, and clinic visits are provided free of charge, and trial teams often help reimburse travel costs.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time and for any reason. Your usual medical care will continue unaffected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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