- 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
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