Plitidepsin in adult patients with COVID-19 requiring hospital admission : A long-term follow-up analysis
Varona, Jose F. (Universidad San Pablo-Centro de Estudios Universitarios (CEU))
Landete, Pedro (Universidad Autónoma de Madrid)
Paredes, Roger (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Vates, Roberto (Hospital Universitario de Getafe (Madrid))
Torralba, Miguel (Universidad de Alcalá)
Guisado-Vasco, Pablo (Universidad Europea de Madrid)
Porras, Lourdes (Hospital General de Ciudad Real)
Muñoz, Patricia (Hospital General Universitario Gregorio Marañón. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM))
Gijon, Paloma (Hospital General Universitario Gregorio Marañón. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM))
Ancochea, Julio (Universidad Autónoma de Madrid)
Saiz, Elena (Virology Unit, PharmaMar, SA)
Meira, Fernanda (PharmaMar, SA)
Jimeno, Jose M. (PharmaMar, SA)
Lopez-Martin, Jose A. (PharmaMar, SA)
Estrada, Vicente (Universidad Complutense de Madrid)
Universitat Autònoma de Barcelona

Date:	2023
Abstract:	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;).
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Plitidepsin ; COVID-19 ; SARS-CoV-2 ; Long COVID ; Post-COVID-19 complications
Published in:	Frontiers in cellular and infection microbiology, Vol. 13 (february 2023) , ISSN 2235-2988

DOI: 10.3389/fcimb.2023.1097809
PMID: 36909731

8 p, 1.0 MB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Research articles
Articles > Published articles