drugset

drugset / Trial / NCT04784559

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

NCT04784559 ↗

Phase 3 Terminated 205 enrolled PharmaMar

RandomizedParallel-groupOpen-labelTreatment

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

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