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

Exclusion Criteria

• •1. Last SARS-CoV-2 vaccine dose during the previous 30 days.
• •2. Patients with active uncontrolled infections.
• •3. Patients infected by SARS-CoV-2 virus in the last 90 days prior to the screening visit.
• •4. Patients receiving treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers (Annex 1) throughout plitidepsin treatment period and until 24-h washout period.
• •5. Pacients receiving chronic glucocorticoid therapy (high-dose corticosteroids \[ie, 20 mg of prednisone daily or equivalent for ≥2 weeks)
• •6. Any of the following cardiac conditions or risk factors:
• •* Cardiac infarction or cardiac surgery episode within the last six months 14
• •* History of known congenital QT prolongation;
• •* Known structural cardiomyopathy with abnormal left ventricular ejection fraction (LVEF) \<50%;
• •* Current clinical evidence of heart failure or acute cardiac ischaemia (New York Heart Association (NYHA) class III-IV).
• •7. Hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol) or contraindication to receive systemic glucocorticoids, antihistamine H1/H2 receptor agents, or antiserotonine 5HT3 receptors drugs.
• •8. Mast cell activation syndrome.
• •9. Females who are pregnant (negative serum or urine pregnancy test required for all females of childbearing potential at screening) or breast-feeding.
• •10. Females of childbearing potential (females who are not surgically sterile or postmenopausal defined as amenorrhea for \>12 months) who are not using highly effective contraceptive methods, while on study treatment and for 6 months after last dose of plitidepsin. Fertile males with partners of childbearing potential must use condom during treatment and for 6 months after last dose of plitidepsin. Refer to Annex 2 for contraception requirements.
• •11. Unable to consent and/or comply with study requirements, in the opinion of the investigator.
• •12. Currently participating or participated in a clinical trial within the prior