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

PHASE2RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

February 7, 2025

Primary Completion Date

June 1, 2026

Study Completion Date

June 1, 2026

Conditions
Post COVID-19 ConditionLong COVID SyndromePersistent COVID-19Persistent COVID ConditionLong COVID
Interventions
DRUG

Plitidepsin 1.5 mg/day

"Receive 1.5 mg/day of plitidepsin intravenously (IV) over a 1-hour infusion for 3 consecutive days every 15 days during 4 treatment periods.~The participant will receive the following pre-medication before receiving the study treatment:~* Palonosetron 0.25 mg IV~* Dexchlorpheniramine maleate 5 mg IV (or equivalent to H1 receptor antihistamines)~* Famotidine 40 mg oral (60 minutes before starting the plitidepsin/placebo infusion)~* Dexamethasone phosphate 8 mg IV (equivalent to 6.6 mg of dexamethasone)~Premedication should be completed 20-30 minutes before starting the plitidepsin/placebo infusion."

DRUG

Placebo

"Receive placebo intravenously (IV) over a 1-hour infusion for 3 consecutive days every 15 days during 4 treatment periods.~The participant will receive the following pre-medication before receiving the study treatment:~* Palonosetron 0.25 mg IV~* Dexchlorpheniramine maleate 5 mg IV (or equivalent to H1 receptor antihistamines)~* Famotidine 40 mg oral (60 minutes before starting the plitidepsin/placebo infusion)~* Dexamethasone phosphate 8 mg IV (equivalent to 6.6 mg of dexamethasone)~Premedication should be completed 20-30 minutes before starting the plitidepsin/placebo infusion."

DRUG

Placebo and Plitidepsin 1.5mg/day

"Receive placebo intravenously (IV) over a 1-hour infusion for 3 consecutive days every 15 days during two treatment periods and receive plitidepsin 1.5mg/day during the last two treatment periods.~The participant will receive the following pre-medication before receiving the study treatment:~* Palonosetron 0.25 mg IV~* Dexchlorpheniramine maleate 5 mg IV (or equivalent to H1 receptor antihistamines)~* Famotidine 40 mg oral (60 minutes before starting the plitidepsin/placebo infusion)~* Dexamethasone phosphate 8 mg IV (equivalent to 6.6 mg of dexamethasone)~Premedication should be completed 20-30 minutes before starting the plitidepsin/placebo infusion."

Trial Locations (1)

08916

RECRUITING

Hospital Universitari Germans Trias i Pujol, Badalona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PharmaMar

INDUSTRY

collaborator

IrsiCaixa

OTHER

lead

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

OTHER

NCT06766825 - Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults with Post-COVID-19 Condition (PCC) | Biotech Hunter | Biotech Hunter