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We are launching the Thalassa clinical trial to test a medication for long COVID

22/01/2025
We are launching the Thalassa clinical trial to test a medication for long COVID

The Fight Infections Foundation and the biopharmaceutical company PharmaMar launch a phase II study to evaluate the safety and efficacy of plitidepsin as a treatment for adult patients with long COVID.

Clinical Trial Thalassa

Patients involved in the study

The study involves an intervention period where four cycles of three consecutive days of treatment will be administered every two weeks. After completing the intervention period, a 90-day follow-up period will be conducted.

This clinical trial will include 90 participants divided into three groups. One group will receive plitidepsin treatment for all four cycles, another group will receive two cycles of placebo followed by two cycles of plitidepsin, and the third group will receive placebo for all four treatment cycles.

To assess safety during the study, two interim analyses will be conducted when 30% and 50% of the participants are enrolled.

Study Objectives

Primary Objective

Evaluate changes in the general health of patients in each treatment group using the PROMIS-29® system.

The PROMIS-29 is a validated scale that assesses general health aspects, such as anxiety, physical function, etc., through questionnaires.

Secondary Objective

Evaluate the safety and tolerability of plitidepsin compared to placebo by analyzing adverse events in patients with long COVID.

This study, promoted by the Fight Infections Foundation, will be carried out by ScienHub Research Support, a unit specialized in clinical trials, in collaboration with PharmaMar under an Independent Sponsored Study (ISS) agreement, involving patients from the Germans Trias i Pujol University Hospital. The study also benefits from the collaboration of IrsiCaixa.

Dr. Lourdes Mateu, head of the COVID-19 section at the Fight Infections Foundation and a doctor at the Germans Trias Hospital, states that the goal is to provide scientific evidence to better understand this condition and offer a concrete therapeutic option for patients who currently lack effective treatments.

Long COVID

After an acute infection with the SARS-CoV-2 virus, most patients recover and return to normal. However, between 5% and 15% continue to experience the same symptoms beyond three months. This condition is known as long COVID.

Patients with long COVID often had a mild to moderate initial SARS-CoV-2 infection, and most did not require hospitalization. It is also worth noting that long COVID is more common in women aged 40 to 50. Symptoms are highly diverse and can affect all organs and systems of the human body. These symptoms can last for months or even years, significantly deteriorating the quality of life for some patients.

Common symptoms of long COVID include:

  1. Persistent fatigue and weakness.
  2. Shortness of breath or difficulty breathing.
  3. Chest pain or heart palpitations.
  4. Muscle and joint pain.
  5. Headaches.
  6. Neurological issues, such as difficulty concentrating and memory loss.
  7. Sleep disturbances.
  8. Depression and anxiety.
  9. Loss of taste and smell.
  10. Gastrointestinal problems.

The reasons why some patients continue to experience these symptoms remain unknown. However, global studies support several hypotheses, including viral persistence, inflammation, autoimmunity, alterations in the microbiota, or issues with small blood vessels.

Currently, the treatment for patients with long COVID focuses on alleviating symptoms and improving their quality of life. However, these interventions do not address or resolve the underlying cause of the disease.

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