Plitidepsin in adult patients with COVID-19 requiring hospital admission: A long-term follow-up analysis

• Published in: Frontiers in cellular and infection microbiology Vol. 13; p. 1097809
• Main Authors: Varona, Jose F, Landete, Pedro, Paredes, Roger, Vates, Roberto, Torralba, Miguel, Guisado-Vasco, Pablo, Porras, Lourdes, Muñoz, Patricia, Gijon, Paloma, Ancochea, Julio, Saiz, Elena, Meira, Fernanda, Jimeno, Jose M, Lopez-Martin, Jose A, Estrada, Vicente
• Format: Journal Article
• Language: English
• Published: Switzerland Frontiers Media S.A 22-02-2023
• Subjects: Adult; Cellular and Infection Microbiology; COVID-19; Follow-Up Studies; Hospitals; Humans; long COVID; plitidepsin; post-COVID-19 complications; SARS-CoV-2; Treatment Outcome; COVID-19; plitidepsin; SARS-CoV-2; long COVID; post-COVID-19 complications
• ISSN: 2235-2988; 2235-2988
• DOI: 10.3389/fcimb.2023.1097809

The APLICOV-PC study assessed the safety and preliminary efficacy of plitidepsin in hospitalized adult patients with COVID-19. In this follow-up study (E-APLICOV), the incidence of post-COVID-19 morbidity was evaluated and any long-term complications were characterized.
Between January 18 and March 16, 2022, 34 of the 45 adult patients who received therapy with plitidepsin in the APLICOV-PC study were enrolled in E-APLICOV (median time from plitidepsin first dose to E-APLICOV enrollment, 16.8 months [range, 15.2-19.5 months]). All patients were functionally autonomous with regard to daily living (Barthel index: 100) and had normal physical examinations.
From the APLICOV-PC date of discharge to the date of the extension visit, neither Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5) grade 3-4 complications nor QT prolongation or significant electrocardiogram (EKG) abnormalities were reported. Five (14.7%) patients had another COVID-19 episode after initial discharge from APLICOV-PC, and in 2 patients (5.9%), previously unreported chest X-ray findings were documented. Spirometry and lung-diffusion tests were normal in 29 (85.3%) and 27 (79.4%) patients, respectively, and 3 patients needed additional oxygen supplementation after initial hospital discharge. None of these patients required subsequent hospital readmission for disease-related complications.
In conclusion, plitidepsin has demonstrated a favorable long-term safety profile in adult patients hospitalized for COVID-19. With the constraints of a low sample size and a lack of control, the rate of post-COVID-19 complications after treatment with plitidepsin is in the low range of published reports. (ClinicalTrials.gov Identifier: NCT05121740; https://clinicaltrials.gov/ct2/show/NCT05121740).