Summary of COVID-19 plitidepsin studies

1. Landete et al., A Phase III Randomized Controlled Trial of Plitidepsin, a Marine-Derived Compound, in Hospitalized Adults With Moderate COVID-19

137 patient plitidepsin late treatment RCT: 1% lower mortality (p=1).
RCT with 205 hospitalized moderate COVID-19 patients showing a trend towards faster time to sustained withdrawal of oxygen supplementation with plitidepsin treatment (1.5 mg/day or 2.5 mg/day for 3 days) compared to standard of care. The trial was terminated early due to a drop in COVID-19-related hospitalizations. Plitidepsin was generally well tolerated.
Aug 2024, Clinical Infectious Diseases, https://academic.oup.com/cid/article/79/4/910/7740910, https://c19p.org/landete

2. PharmaMar et al., A Multicentre, Open Label, Randomised, Controlled, Basket, Pragmatic, Phase II, Clinical and Translational Study to Determine the Efficacy and Safety of Plitidepsin Versus Control in Immunocompromised Adult Patients With Symptomatic COVID-19 Requiring Hospital Care

37 patient plitidepsin late treatment RCT: 36% higher mortality (p=1).
RCT 37 hospitalized immunocompromised patients, showing no significant benefit with plitidepsin treatment.
Dec 2024, PharmaMar, NCT05705167, https://clinicaltrials.gov/study/NCT05705167, https://c19p.org/pharmamar