Plitidepsin

A natural depsipeptide with antitumour properties.

Phase of research

Potential treatment - theoretical effect

How it helps

Antiviral

Drug status

Used to treat other disease

1
Supporting references
0
Contradictory references
10
AI-suggested references
4
Clinical trials

General information

Plitidepsin on PubChem


Marketed as

APLIDIN; APLIDINE

 

Structure image - Plitidepsin

CC[C@H](C)[C@@H]1[C@H](CC(=O)O[C@H](C(=O)[C@@H](C(=O)N[C@H](C(=O)N2CCC[C@H]2C(=O)N([C@H](C(=O)O[C@@H]([C@@H](C(=O)N1)NC(=O)[C@@H](CC(C)C)N(C)C(=O)[C@@H]3CCCN3C(=O)C(=O)C)C)CC4=CC=C(C=C4)OC)C)CC(C)C)C)C(C)C)O


Supporting references

AI-suggested references

Clinical trials

ID Title Status Phase Start date Completion date
NCT04819919 Study to Evaluate the Viral Load Reduction of a Single Dose of Plitidepsin in Adult Patients With COVID-19 Not yet recruiting Phase 2 Apr/15/2021 Oct/15/2021
  • Alternative id - APL-D-005-21 / APLIDURG
  • Interventions - Drug: Plitidepsin|Drug: Symptomatic Treatment
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hospital Univeristario La Paz, Madrid, Madrid N, Spain|Hospital Univeristario Infanta Leonor, Madrid, Spain|Hospital Universitario Ramón y Cajal, Madrid, Spain|Hospital Universitario Clínico San Carlos, Madrid, Spain
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 122
  • Age - 18 Years to 80 Years   (Adult, Older Adult)
  • Outcome measures - Change in viral load and symptoms recovery (both must be met in order to achieve the objective)|Change in viral load|Symptoms recovery|Time to reduce viral load|Progression to hospitalisation|Need for ICU admission|Mortalitiy assesment|Development of sequels|Normalization of analytical parameters|Normalization of clinical criteria|Frequency of occurrence of adverse events
NCT04382066 Proof of Concept Study to Evaluate the Safety Profile of Plitidepsin in Patients With COVID-19 Completed Phase 1 May/12/2020 Nov/26/2020
  • Alternative id - APL-D-002-20|2020-001993-31
  • Interventions - Drug: Plitidepsin 1.5 mg/day|Drug: Plitidepsin 2.0 mg/day|Drug: Plitidepsin 2.5 mg/day
  • Study type - Interventional
  • Study results - Has Results
  • Locations - Hospital Universitario Hm Montepríncipe, Boadilla Del Monte, Madrid, Spain|Hospital Germans Trias i Pujol, Badalona, Spain|Hospital Clínic de Barcelona, Barcelona, Spain|Hospital de la Santa Creu i Sant Pau, Barcelona, Spain|Hospital Ciudad Real, Ciudad Real, Spain|Hospital Universitario de Getafe, Getafe, Spain|Hospital Universitario de Guadalajara, Guadalajara, Spain|Hospital Universitari Arnau de Vilanova, Lleida, Spain|Hospital La Princesa, Madrid, Spain|Hospital Gregorio Marañón, Madrid, Spain|Hospital Ramón Y Cajal, Madrid, Spain|Hospital Clínico San Carlos, Madrid, Spain|Hosptial Quironsalud Madrid, Madrid, Spain
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 46
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Frequency of Occurrence of Neutropenia ≥ Grade 3|Frequency of Occurrence of Thrombocytopenia ≥ Grade 3|Frequency of Occurrence of Anemia ≥ Grade 3|Frequency of Occurrence of Lymphopenia ≥ Grade 3|Frequency of Occurrence of CPK Increase ≥ Grade 3|Frequency of Occurrence of Increase ALT and / or AST ≥ Grade 3|Frequency of Occurrence of Increase Total Bilirubin or Direct Bilirubin ≥ Grade 3|Frequency of Occurrence of Neurotoxicity ≥ Grade 3|Frequency of Occurrence of QT-QTc Interval Extension ≥ Grade 3|Frequency of Occurrence of Other Adverse Events ≥ Grade 3|Percentage of Patients in Whom Treatment Cannot be Completed.|Percentage of Patients With Adverse Events.|Percentage of Patients With Serious Adverse Events.|Percentage of Patients With ECG Abnormalities.|Change in the Viral Load of SARS-CoV-2|Time to Negative PCR Test for COVID-19|Mortality|Percentage of Patients Requiring Invasive Mechanical Ventilation and / or ICU Admission|Percentage of Patients Requiring Non-invasive Mechanical Ventilation|Percentage of Patients Requiring Oxygen Therapy
NCT04784559 Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection Recruiting Phase 3 Jun/04/2021 Dec/01/2022
  • Alternative id - APL-D-003-20|2020-005951-19
  • Interventions - Drug: Plitidepsin|Drug: Dexamethasone|Drug: Remdesivir|Drug: Favipiravir
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Instituto Medico Platense S.A., La Plata, Buenos Aires, Argentina|Clinica Privada Monte Grande S.A, Monte Grande, Buenos Aires, Argentina|Clinica Central S.A., Villa Regina, Rio Negro, Argentina|Sanatorio Parque - Rosario, Rosario, Santa Fe, Argentina|Hospital General Agudos Ignacio, Buenos Aires, Argentina|Hospital Francisco Muñiz, Ciudad autónoma de Buenos Aires, Argentina|Hospital Rawson, Cordoba, Argentina|Hospital São Rafael, Salvador, BA, Brazil|Chronos Pesquisa Clínica, Brasília, DF, Brazil|Hospital Felicio Rocho, Belo Horizonte, MG, Brazil|Santa Casa de Misericordia de Passos, Passos, MG, Brazil|CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda, Natal, RN, Brazil|Hospital Moinhos de Vento (HMV), Porto Alegre, RS, Brazil|Hospital São José, Criciúma, SC, Brazil|CEMEC - Centro Multidisciplinar de Estudos Clínicos, São Bernardo Do Campo, Brazil|University Multiprofile Hospital for Active Treatment Sveta Ekaterina EAD, Dimitrovgrad, Bulgaria|Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Haskovo, Haskovo, Bulgaria|MHAT "Dr. Nikola Vasiliev" AD, Kyustendil, Bulgaria|Military Medical Academy - MBAL Pleven, Pleven, Bulgaria|"Specialised Hospital for Active Treatment for Pneumophthisiatric Diseases Dr. Dimitar Gramatikov - Ruse" Ltd Department of Pneumology and Phthisiatry, Ruse, Bulgaria|SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd., Ruse, Bulgaria|University First MHAT "St.Yoan Krastitel"-Sofia EAD, Sofia, Bulgaria|University Multiprofile Hospital for Active Treatment ACIBADEM CITY CLINIC TOKUDA HOSPIAL, Sofia, Bulgaria|"MHAT "Sveta Anna"" - Sofia AD, Sofia, Bulgaria|CliniSalud del Sur S.A.S - Centro de Investigación, Envigado, Antioquia, Colombia|Organización Clinica Bonnadona Prevenir S.A.S, Barranquilla, Atlantico, Colombia|Clínica de la Costa Ltda., Barranquilla, Atlántico, Colombia|Sociedad de Cirugía de Bogotá; Hospital de San José, Bogotá, Bogotá D.C., Colombia|Hospital Universitario MEDERI, Bogotá, Bogotá D.C., Colombia|Caja de Compensacion Familiar de Caldas, Manizales, Caldas, Colombia|CH Valence, Valence, Drome, France|Centre Hospitalier Universitaire (CHU) Dijon Bourgogne - Hopital Francois Mitterand, Dijon, France|Nouvel Hôpital Civil Service des maladies infectieuses, Strasbourg, France|Centre Hospitalier Regional et Universitaire de Tours (CHRU Tours) - Hopital Bretonneau, Tours, France|Democritus University Hospital University General Hospital of Alexandroupolis, Alexandroupoli, Greece|Evangelismos Hospital General Hospital of Athens Evangelismos, Intensive Care Unit, Athens, Greece|Sotiria Hospital General Hospital of Chest Diseases of Athens "Sotiria" 3rd Department of Internal Medicine of University of Athens, Athens, Greece|General Hospital of Athens Alexandra, Athens, Greece|General Hospital of Athens "Laiko", University of Athens Agiou, Athens, Greece|Attikon Hospital, Chaïdári, Greece|Tzaneio Hospital General Hospital of Piraeus Tzaneio, Piraeus, Greece|Hospital Cardiologica Aguascalientes, Aguascalientes, Ags, Mexico|Centro Médico ABC, Mexico City, Cdmx, Mexico|Hospital Médica Sur, Mexico City, Cdmx, Mexico|INER, Mexico City, Cdmx, Mexico|Sanatorio Palmore, A.C., Chihuahua, CHH, Mexico|Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, DIF, Mexico|Centro de Investigación Clínica Chapultepec, Morelia, Michoacan, Mexico|Hospital Español, Ciudad de México, Méx, Mexico|Hospital Angeles (Lomas), Mexico City, Méx, Mexico|Universidad Autonoma de Nuevo Leon - Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, NL, Mexico|Hospital Alberto Sabogal Sologuren, Bellavista, Lima, Peru|Hospital de Chancay, Chancay, Lima, Peru|Hospital Nacional Hipolito Unanue (HNHU), El Agustino, Lima, Peru|Universidad Peruana Cayetano Heredia (UPCH) - Hospital Cayetano Heredia (HCH), Lima Cercado, Lima, Peru|HULC - Hospital de Curry Cabral, Lisboa, Portugal|Spitalul Clinic De Boli Infectioase Cluj-Napoca, Sectia HIV/SIDA, Cluj-Napoca, Cluj, Romania|Spitalul Clinic de Boli Infectioase Constanta, Constanţa, Tomis, Romania|Institutul National De Boli Infectioase "Prof. Dr. Matei Bals", Bucharest, Romania|Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor Babes - Bucharest, Bucharest, Romania|Institutul National De Boli Infectioase "Prof. Dr. Matei Bals", Bucharest, Romania|Spitalul Clinic Universitar de Urgenta Bucuresti, Bucharest, Romania|Spitalul Clinic De Boli Infectioase "Sfanta Parascheva" IASI, Sectia Boli Infectioase III, Iaşi, Romania|Spitalul Judetean de Urgenta 'Sf. Ioan cel Nou' Suceava, Sectia de Boli Infectioase, Suceava, Romania|Netcare Lakeview Hospital, Benoni, Gauteng, South Africa|Tiervlei Trial Centre, Cape Town, Western Cape, South Africa|TASK eden, George, Western Cape, South Africa|Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain|Hospital Universitari de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain|Hospital Universitario Puerto Real, Puerto Real, Cádiz.Spain, Spain|Hospital Universitario de Jerez de la Frontera, Jerez De La Frontera, Cádiz, Spain|Hospital Universitario HM Montepríncipe, Boadilla Del Monte, Madrid, Spain|Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain|Hospital Universitario de Getafe, Getafe, Madrid, Spain|HM Puerta del Sur, Móstoles, Madrid, Spain|Hospital Universitario de Móstoles, Móstoles, Madrid, Spain|Hospital Quirónsalud Madrid, Pozuelo De Alarcón, Madrid, Spain|HM Torrelodones, Torrelodones, Madrid, Spain|Hospital Costa Del Sol, Marbella, Málaga, Spain|Hospital Quirón Marbella, Marbella, Málaga, Spain|Hospital Álvaro Cunqueiro, Vigo, Pontevedra, Spain|Hospital Universitario de Cruces, Barakaldo, Vizcaya, Spain|Hospital General Universitario de Alicante, Alicante, Spain|Complejo Asistencial Universitario de Burgos - Hospital Universitario de Burgos, Burgos, Spain|Universidad de Cadiz (UCA) - Hospital Universitario Puerta del Mar (HUPM), Cadiz, Spain|Hospital Universitario Virgen de las Nieves (HUVN), Granada, Spain|Hospital Clinico San Cecilio, Granada, Spain|Hospital Universitario de Guadalajara, Guadalajara, Spain|Hospital Universitari Arnau de Vilanova de Lleida, Lleida, Spain|H.U. La Princesa, Madrid, Spain|Hospital Gregorio Marañón, Madrid, Spain|Hospital Universitario Moncloa, Madrid, Spain|Hospital Infanta Leonor, Madrid, Spain|Hospital Universitario Ramón y Cajal, Madrid, Spain|Fundacion Jimenez Diaz, Madrid, Spain|Hospital Clínico San Carlos, Madrid, Spain|Hospital 12 Octubre, Madrid, Spain|H. HM Sanchinarro, Madrid, Spain|Hospital de Emergencias Enfermera Isabel Zendal, Madrid, Spain|Complexo Hospitalario de Pontevedra, Pontevedra, Spain|Hospital Universitario de Salamanca, Salamanca, Spain|Instituto de Investigación Sanitaria Valdecilla (IDIVAL), Santander, Spain|Hospital Universitario Virgen del Rocío, Sevilla, Spain|Ege University Medical School, Department of Infectious Diseases and Clinical Microbiology, Bornova, İzmir, Turkey|T.C. Saglik Bakanligi Tepecik Egitim ve Arastirma Hastanesi - Enfeksiyon Hastaliklari ve Klinik Mikrobiyoloji Klinigi, Konak, Izmir, Turkey|Kocaeli Universitesi - Kocaeli Universitesi Tip Fakultesi - Kocaeli Universitesi Arastirma ve Uygulama Hastanesi, İzmit, Kocaeli, Turkey|Hacettepe University, School of Medicine, Ankara, Turkey|Ankara City Hospital, Ankara, Turkey
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 609
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Percentage of patients who achieve complete recovery:|Time to complete recovery|Clinical status assessed by 11-category WHO Clinical Progression Scale:|Proportion of patients with treatment-emergent adverse events (TEAEs)|Proportion of patients with Grade ≥3 TEAEs|Proportion of patients with serious adverse events (SAEs)|Proportion of patients with serious adverse reactions (SARs)|Proportion of patients with adverse events (AEs) of special interest|Number and severity of treatment emergent adverse events as per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 criteria (CTCAE v5.0)|Proportion of patients requiring re-admission for COVID-19 signs or symptoms|Duration of oxygen therapy (in days)|Proportion of patients requiring high-flow oxygen|Proportion of patients requiring noninvasive mechanical ventilation|Proportion of patients requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)|Proportion of patients requiring admission to Intensive Care Unit (ICU)|Duration of hospitalization in ICU|Proportion of patients receiving subsequent antiviral therapies or immunomodulatory drugs|Proportion of patients with nosocomial infection|Mortality|Change in SARS-CoV-2 viral, as measured by quantitative polymerase chain reaction (qPCR) from samples of oro-nasopharyngeal exudate|Proportion of patients with undetectable SARS-CoV-2 viral load, as measured by qPCR from samples of oro-nasopharyngeal exudate|Change in inflammatory biomarker: C-reactive protein (CRP)|Change in inflammatory biomarker: ferritin|Change in inflammatory biomarker: IL-6, IL-1β, IL-10|Change in inflammatory biomarker: tumour necrosis factor alpha (TNFα)|Proportion of patients with serologic response anti-SARS-CoV-2|Time to therapy intensification (WHO >6 [intubation] or initiation of other antiviral/immunomodulating agent)|Percentage of patients requiring increased oxygen therapy on study
NCT05121740 Extension Study in a Cohort of Adult Patients With COVID-19 Infection Active, not recruiting Phase 1|Phase 2 Jan/18/2022 Jun/01/2022
  • Alternative id - AV-APL-A-003-21|2021-004966-37
  • Interventions - Drug: Plitidepsin 1.5 mg / day|Drug: Plitidepsin 2.0 mg / day|Drug: Plitidepsin 2.5 mg / day
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain|Hospital Universitario HM Montepríncipe, Boadilla del monte, Madrid, Spain|Hospital Universitario Quironsalud Madrid, Pozuelo De Alarcón, Madrid, Spain|Hospital General de Ciudad Real, Ciudad Real, Spain|Hospital Universitario de Getafe, Getafe, Spain|Hospital Universitario de Guadalajara, Guadalajara, Spain|Hospital Universitario Ramón y Cajal, Madrid, Spain|Hospital General Universitario Gregorio Marañón, Madrid, Spain|Hospital Universitario La Princesa, Madrid, Spain|Hospital Universitario Clínico San Carlos, Madrid, Spain
  • Study designs - Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 42
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Incidence of complications|Patients requiring hospital readmission|Patients requiring oxygen therapy|Duration of oxygen therapy|Patients with complications|Barthel index|Arterial oxygen saturation (SaO2)|Ratio of partial pressure arterial oxygen (PaO2) and fraction of inspired oxygen (FiO2)|Forced vital capacity (FVC)|Forced expiratory volume 1 (FEV1)|FEV1/FVC|Diffusion test|6 minute walking test|Modified Medical Research Council (mMRC) Dyspnea Scale|Patients with alterations in chest radiography|Patients with ≥grade 2 alterations in laboratory parameters|Patients with electrocardiogram alterations|Patients with echocardiogram / multigated acquisition scan (ECHO/MUGA) alterations