Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults With Post-COVID-19 Condition (PCC)
Phase II Proof-of-concept, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults With Post-COVID-19 Condition (PCC)
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
90 participants
Feb 7, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
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.
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.
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.
Locations(1)
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NCT06766825