Actively Recruiting
Phase II Randomized, Double-blind, Placebo-controlled Study Evaluating Plitidepsin for 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
13 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
Researchers are evaluating plitidepsin as a potential treatment for adults with Post-COVID-19 Condition (PCC), also known as Long COVID. This randomized, double-blind, placebo-controlled Phase II study aims to assess whether plitidepsin is effective, safe, and well tolerated in people experiencing moderate to severe functional disability due to PCC. The study will compare clinical and laboratory benefits of plitidepsin against placebo in about 90 participants. Participants will be divided into three groups: one receiving plitidepsin intravenously (IV) for four treatment cycles spaced 15 days apart, each cycle lasting 3 consecutive days; another receiving placebo during the first two cycles followed by plitidepsin for the last two cycles; and the last group receiving placebo for all four cycles. Each infusion lasts one hour, preceded by a set of pre-medications including palonosetron, dexchlorpheniramine maleate or equivalent, famotidine, and dexamethasone phosphate. After the intervention period, participants will be followed up for approximately 90 days. During the study, participants will undergo various assessments including patient-reported outcome scores, functional status scales, quality of life measures, neuropsychological evaluations, and laboratory tests for inflammation, immune response, and viral markers. Safety and tolerability will be monitored through adverse event reports, with interim analyses planned. The total study duration including intervention and follow-up is about 135 days.
CONDITIONS
Brief Title
Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults With Post-COVID-19 Condition (PCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female individuals 18 years old or older
- Evidence of SARS-CoV-2 infection at least 90 days before recruitment confirmed 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 2 months and not explained by another diagnosis
- Moderate to severe functional disability, unable to perform all usual duties or activities (grades 3 or 4 in PCFS scale)
- Willingness and ability to follow study requirements and available for follow-up
- Capacity to understand study information and provide informed consent
You will not qualify if you...
- COVID-19 vaccine dose received within the past 30 days
- Active uncontrolled infections
- SARS-CoV-2 infection within 90 days prior to screening
- Treatment with strong CYP3A4 inhibitors or inducers during treatment and 24-hour washout
- Chronic high-dose glucocorticoid use (20 mg prednisone daily or equivalent for 2 weeks or more)
- Recent cardiac events or conditions including infarction or surgery within 6 months, congenital QT prolongation, cardiomyopathy with low ejection fraction, or severe heart failure
- Known hypersensitivity to study drug components or contraindications to pre-medications
- Mast cell activation syndrome
- Pregnant or breastfeeding females
- Females of childbearing potential not using highly effective contraception during and 6 months after treatment; fertile males with partners of childbearing potential must use condoms
- Inability to consent or comply with study requirements
- Participation in another clinical trial within prior period (incomplete text)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 45 days
Participants receive intravenous infusions of plitidepsin or placebo over 1 hour for 3 consecutive days every 15 days during 4 treatment periods. Premedications are given before each infusion.
4 treatment periods with 3 consecutive infusion days each (total 12 infusion days)
Duration - Up to 90 days after treatment
Participants are monitored for safety, symptom changes, and various health assessments after treatment ends.
Visits on Day 10, Day 30, and Day 90 post-treatment
Trial Site Locations
Total: 1 location
1
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Actively Recruiting
Research Team
L
Lourdes Mateu Pruñonosa, phD, MD
C
Cora Loste, phD, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here