Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection

Summary

Treatment of patients hospitalised for management of moderate COVID-19 infection

Timeline

Start

2021-06-04

Primary completion

2023-03-01

Completion

2023-03-01

Outcome

Missed primary endpoint

Stopped (Enrollment): “Sponsor has decided to end the study prematurely based on significant difficulties in the recruitment of patients, despite the implementation of corrective measures that still failed to increase the accrual rate required for a feasible completion.”

registry analysis (superiority test); Plitidepsin 2.5 mg Arm vs Control Arm; p = 0.8751 NCT04784559 ↗

registry analysis (superiority test); Plitidepsin 1.5 mg Arm vs Control Arm; p = 0.0625 NCT04784559 ↗

Publications

• Landete P, Caliman-Sturdza OA, Lopez-Martin JA, Preotescu L, Luca MC, Kotanidou A, Villares P, Iglesias SP, Guisado-Vasco P, Saiz-Lou EM, Del Carmen Farinas-Alvarez M, de Lucas EM, Perez-Alba E, Cisneros JM, Estrada V, Hidalgo-Tenorio C, Poulakou G, Torralba M, Fortun J, Garcia-Ocana P, Lemaignen A, Marcos-Martin M, Molina M, Paredes R, Perez-Rodriguez MT, Raev D, Ryan P, Meira F, Gomez J, Torres N, Lopez-Mendoza D, Jimeno J, Varona JF. A Phase III Randomized Controlled Trial of Plitidepsin, a Marine-Derived Compound, in Hospitalized Adults With Moderate COVID-19. Clin Infect Dis. 2024 Oct 15;79(4):910-919. doi: 10.1093/cid/ciae227.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Plitidepsin	Peptide	1.5 mg	Intravenous
Subject	Plitidepsin	Peptide	2.5 mg	Intravenous
Background	Dexamethasone	Small molecule	—	Intravenous
Comparator	Favipiravir	Small molecule	—	—
Comparator	Remdesivir	Small molecule	—	—

Indications