Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06766825

Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults With Post-COVID-19 Condition (PCC)

Led by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · Updated on 2026-04-03

90

Participants Needed

1

Research Sites

81 weeks

Total Duration

On this page

Sponsors

F

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Lead Sponsor

P

PharmaMar

Collaborating Sponsor

AI-Summary

What this Trial Is About

The study aims to prove that plitidepsin could be an efficacious, safe, and well-tolerated therapy for PCC. To this end, we will perform a randomized, double-blind study comparing the clinical and laboratory benefits of plitidepsin vs. placebo in 90 subjects with moderate to severe functional disability. The study consists of an intervention period and a follow-up period, with a total of 135 +/-3 days approximately between both periods. During the intervention period, four treatment cycles will be administered, scheduled every 15 days (every 2 weeks), with intravenous (IV) infusion over three consecutive days. After completing the intervention period, a 90-day (+/-5) follow-up period will be conducted. Subjects in arm A will receive the plitidepsin 1.5 mg/day 1h-IV during the four treatment periods on Days 1 to 3, Days 15 to 17, Days 29 to 31 and Days 43 to 45. Subjects in arm B will receive 1h-IV placebo 1 vial /day during the first two treatment periods and will receive the plitidepsin 1.5 mg/day 1h-IV during the last two treatment periods. Subjects in arm C will receive 1h-IV placebo 1 vial/day during the four treatment periods.

CONDITIONS

Official Title

Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults With Post-COVID-19 Condition (PCC)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female individuals 18 years old or older.
  • SARS-CoV-2 infection confirmed at least 90 days before study recruitment by PCR, antigen test, or positive antibody test.
  • Presence of three or more Post-COVID-19 Condition symptoms affecting at least two organs, lasting at least two months, starting at least 90 days after initial infection.
  • Functional disability with inability to perform all usual duties or activities, defined as grades 3 or 4 in PCFS.
  • Willingness to follow the study protocol and available for the planned follow-up duration.
  • Ability to understand study information and provide informed consent.
Not Eligible

You will not qualify if you...

  • Received SARS-CoV-2 vaccine dose within the past 30 days.
  • Active uncontrolled infections.
  • SARS-CoV-2 infection within 90 days before screening.
  • Treatment with strong CYP3A4 inhibitors or inducers during treatment and until 24 hours after.
  • Chronic high-dose glucocorticoid therapy (20 mg prednisone daily or equivalent for at least 2 weeks).
  • Recent cardiac infarction or surgery within past 6 months.
  • Known congenital QT prolongation.
  • Structural cardiomyopathy with left ventricular ejection fraction below 50%.
  • Current heart failure or acute cardiac ischemia (NYHA class III-IV).
  • Hypersensitivity to study drugs or premedications.
  • Mast cell activation syndrome.
  • Pregnant or breastfeeding females.
  • Females of childbearing potential not using highly effective contraception during and for 6 months after treatment.
  • Fertile males with partners of childbearing potential not using condoms during and for 6 months after treatment.
  • Unable to consent or comply with study requirements.
  • Participation in another clinical trial within the prior period specified in the protocol.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain, 08916

Actively Recruiting

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Research Team

L

Lourdes Mateu Pruñonosa, phD, MD

CONTACT

C

Cora Loste, phD, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults With Post-COVID-19 Condition (PCC) | DecenTrialz