Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-29 @ 12:15 AM
Study NCT ID:
NCT04784559
Status:
TERMINATED
Last Update Posted:
2025-02-21
First Post:
2021-03-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Italy', 'Peru', 'Portugal', 'South Africa', 'Turkey (Türkiye)']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C098980', 'term': 'plitidepsin'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C000606551', 'term': 'remdesivir'}, {'id': 'C462182', 'term': 'favipiravir'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'virologytrials@pharmamar.com', 'phone': '+34 918466000', 'title': 'Clinical Development Virology Business Unit', 'organization': 'PharmaMar'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The decision was made by the sponsor on 31 January 2023 to prematurely end the study (early termination) based on significant difficulties in the recruitment of patients, despite the implementation of corrective measures.'}}, 'adverseEventsModule': {'timeFrame': 'From Screening to Day 31 +/- 3 days', 'description': 'As pre-specified in the approved Protocol and Statistical Analysis Plan of the study "Safety analyses will be based on the As Treated Population." Adverse events of participants not belonging to the as-treated population: One randomized participant in Plitidepsin 1.5 mg arm, that never received any study treatment, experienced an AE of adult respiratory distress syndrome.', 'eventGroups': [{'id': 'EG000', 'title': 'Plitidepsin 2.5 mg Arm', 'description': 'Participants received plitidepsin 2.5 mg/day intravenous (IV) in addition to dexamethasone on days 1 to 3.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 43, 'seriousNumAtRisk': 63, 'deathsNumAffected': 2, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Plitidepsin 1.5 mg Arm', 'description': 'Participants received plitidepsin 1.5 mg/day IV in addition to dexamethasone on days 1 to 3.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 43, 'seriousNumAtRisk': 67, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Control Arm', 'description': 'Participants received dexamethasone IV on Days 1 to 3. Additionally, in accordance with local treatment guidelines, participants in this group may have received a regulatory-approved antiviral treatment.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 38, 'seriousNumAtRisk': 65, 'deathsNumAffected': 2, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Mouth haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 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'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 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and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 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'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Peripheral venous disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Sustained Withdrawal of Supplementary Oxygen With no Subsequent Reutilisation During Remaining Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin 2.5 mg Arm', 'description': 'Participants received plitidepsin 2.5 mg/day intravenous (IV) in addition to dexamethasone on days 1 to 3.'}, {'id': 'OG001', 'title': 'Plitidepsin 1.5 mg Arm', 'description': 'Participants received plitidepsin 1.5 mg/day IV in addition to dexamethasone on days 1 to 3.'}, {'id': 'OG002', 'title': 'Control Arm', 'description': 'Participants received dexamethasone IV on Days 1 to 3. Additionally, in accordance with local treatment guidelines, participants in this group may have received a regulatory-approved antiviral treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '7'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '8'}]}]}], 'analyses': [{'pValue': '0.8751', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.727', 'ciUpperLimit': '1.53', 'pValueComment': 'Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure', 'estimateComment': 'Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors,', 'groupDescription': 'Plitidepsin 2.5 mg arm versus Control arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors'}, {'pValue': '0.0625', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '0.960', 'ciUpperLimit': '1.96', 'pValueComment': 'Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure', 'estimateComment': 'Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors', 'groupDescription': 'Plitidepsin 1.5 mg arm versus Control arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors'}], 'paramType': 'MEDIAN', 'timeFrame': 'From administration date to Day 31(±3)', 'description': 'Time to sustained withdrawal of oxygen supplementation (in days) with no subsequent reutilisation during remaining study period is defined as the first day, from randomisation through completion of the study, on which a patient i. satisfies categories 0 to 4 on the 11-point WHO Clinical Progression Scale, and ii. has no subsequent reutilisation of oxygen supplementation (5 to 10 on the 11-point WHO Clinical Progression Scale).\n\nThe WHO clinical progression scale provides a measure of illness severity across a range from 0 (uninfected) to 10 (dead).', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat Population'}, {'type': 'SECONDARY', 'title': 'Time to Sustained (i.e., With no Subsequent Readmission to Day 31) Hospital Discharge (Since Randomisation).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin 2.5 mg Arm', 'description': 'Participants received plitidepsin 2.5 mg/day intravenous (IV) in addition to dexamethasone on days 1 to 3.'}, {'id': 'OG001', 'title': 'Plitidepsin 1.5 mg Arm', 'description': 'Participants received plitidepsin 1.5 mg/day IV in addition to dexamethasone on days 1 to 3.'}, {'id': 'OG002', 'title': 'Control Arm', 'description': 'Participants received dexamethasone IV on Days 1 to 3. Additionally, in accordance with local treatment guidelines, participants in this group may have received a regulatory-approved antiviral treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '9'}, {'value': '7', 'comment': 'NA explanation: Variability in participants with or without hospital events is insufficient to calculate the lower and upper CI', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '9'}]}]}], 'analyses': [{'pValue': '0.5945', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.948', 'ciLowerLimit': '0.655', 'ciUpperLimit': '1.37', 'pValueComment': 'Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure', 'estimateComment': 'Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors', 'groupDescription': 'Plitidepsin 2.5 mg arm versus Control arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors'}, {'pValue': '0.3358', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.827', 'ciUpperLimit': '1.70', 'pValueComment': 'Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure', 'estimateComment': 'Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors', 'groupDescription': 'Plitidepsin 1.5 mg arm versus Control arm', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors'}], 'paramType': 'MEDIAN', 'timeFrame': 'From administration date to Day 31(±3)', 'description': 'Time to sustained (i.e., with no subsequent readmission to Day 31) hospital discharge (since randomization)', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat Population'}, {'type': 'SECONDARY', 'title': 'Clinical Status by the 11-category WHO Clinical Progression Scale on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin 2.5 mg Arm', 'description': 'Participants received plitidepsin 2.5 mg/day intravenous (IV) in addition to dexamethasone on days 1 to 3.'}, {'id': 'OG001', 'title': 'Plitidepsin 1.5 mg Arm', 'description': 'Participants received plitidepsin 1.5 mg/day IV in addition to dexamethasone on days 1 to 3.'}, {'id': 'OG002', 'title': 'Control Arm', 'description': 'Participants received dexamethasone IV on Days 1 to 3. Additionally, in accordance with local treatment guidelines, participants in this group may have received a regulatory-approved antiviral treatment.'}], 'classes': [{'title': '0 = uninfected, no viral RNA detected', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': '1 = asymptomatic, viral RNA detected', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': '2 = symptomatic, independent', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': '3 = symptomatic, assistance needed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '4 = hospitalised, no oxygen therapy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': '5 = hospitalised, oxygen by mask or nasal prongs', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': '6 = hospitalised, oxygen by NIV or high flow', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '7 = intubation and mechanical ventilation. pO2/FiO2 >150 or SpO2/FiO2 >200', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '8 = mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or vasopressors', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '9 = mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis, or ECMO', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '10 = dead', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.7252', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.604', 'ciUpperLimit': '2.06', 'pValueComment': '2-sided', 'estimateComment': 'Adjusted Odds Ratio and 95% CI based on a proportional odds model with fixed effects of treatment group and randomisation stratification factors', 'groupDescription': 'Plitidepsin 2.5 mg arm versus Control arm', 'statisticalMethod': 'p-value based on proportional odds model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Proportional odds model with fixed effects of treatment group and randomisation stratification factors'}, {'pValue': '0.0910', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '0.920', 'ciUpperLimit': '3.11', 'pValueComment': '2-sided', 'estimateComment': 'Adjusted Odds Ratio and 95% CI based on a proportional odds model with fixed effects of treatment group and randomisation stratification factors', 'groupDescription': 'Plitidepsin 1.5 mg arm versus Control arm', 'statisticalMethod': 'p-value based on proportional odds model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Proportional odds model with fixed effects of treatment group and randomisation stratification factors'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 8 (±1)', 'description': 'The WHO clinical progression scale provides a measure of illness severity across a range from 0 (uninfected) to 10 (dead).\n\n0 = Uninfected; no viral RNA detected\n\n1. = Ambulatory mild disease. Asymptomatic; viral RNA detected\n2. = Ambulatory mild disease. Symptomatic; independent\n3. = Ambulatory mild disease. Symptomatic; assistance needed\n4. = Hospitalized: moderate disease. Hospitalized; no oxygen therapy\n5. = Hospitalized: moderate disease. Hospitalized; oxygen by mask or nasal prongs\n6. = Hospitalized: severe diseases. Hospitalized; oxygen by NIV or high flow\n7. = Hospitalized: severe diseases. Intubation and mechanical ventilation pO2/FIO2 \\> 150 or SpO2/FIO2 \\> 200\n8. = Hospitalized: severe diseases. Mechanical ventilation pO2 /FIO2 \\<150 (SpO2 /FiO2 \\<200) or vasopressors\n9. = Hospitalized: severe diseases. Mechanical ventilation pO2 /FiO2 \\<150 and vasopressors, dialysis, or ECMO\n10. = dead', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Total Duration of Advanced Oxygen Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin 2.5 mg Arm', 'description': 'Participants received plitidepsin 2.5 mg/day intravenous (IV) in addition to dexamethasone on days 1 to 3.'}, {'id': 'OG001', 'title': 'Plitidepsin 1.5 mg Arm', 'description': 'Participants received plitidepsin 1.5 mg/day IV in addition to dexamethasone on days 1 to 3.'}, {'id': 'OG002', 'title': 'Control Arm', 'description': 'Participants received dexamethasone IV on Days 1 to 3. Additionally, in accordance with local treatment guidelines, participants in this group may have received a regulatory-approved antiviral treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'spread': '9.71', 'groupId': 'OG000'}, {'value': '10', 'spread': '8.21', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '12.66', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From administration date to Day 31(±3)', 'description': 'Total duration of advanced oxygen support (high-flow nasal oxygen, extracorporeal membrane oxygenation -ECMO-, non-invasive ventilation or mechanical ventilation).', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set; number of participants who received advanced oxygen support are presented'}, {'type': 'SECONDARY', 'title': 'Number of Participants in Each Study Group Requiring Admission to ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin 2.5 mg Arm', 'description': 'Participants received plitidepsin 2.5 mg/day intravenous (IV) in addition to dexamethasone on days 1 to 3.'}, {'id': 'OG001', 'title': 'Plitidepsin 1.5 mg Arm', 'description': 'Participants received plitidepsin 1.5 mg/day IV in addition to dexamethasone on days 1 to 3.'}, {'id': 'OG002', 'title': 'Control Arm', 'description': 'Participants received dexamethasone IV on Days 1 to 3. Additionally, in accordance with local treatment guidelines, participants in this group may have received a regulatory-approved antiviral treatment.'}], 'classes': [{'title': 'From Day 1 to Day 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.0402', 'upperLimit': '8.53'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0.0378', 'upperLimit': '8.04'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '0.962', 'upperLimit': '12.9'}]}]}, {'title': 'From Day 1 to Day 8', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '4.59', 'upperLimit': '21.6'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.933', 'upperLimit': '12.5'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1.70', 'upperLimit': '15.0'}]}]}, {'title': 'From Day 1 to Day 15', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '4.59', 'upperLimit': '21.6'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1.65', 'upperLimit': '14.6'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1.70', 'upperLimit': '15.0'}]}]}, {'title': 'From Day 1 to Day 31', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '4.59', 'upperLimit': '21.6'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '2.47', 'upperLimit': '16.6'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1.70', 'upperLimit': '15.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 4, Day 8(±1) , Day 15(±1) and Day 31(±3)', 'description': 'Number of participants in each study group requiring admission to intensive care unit', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Frequency of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin 2.5 mg Arm', 'description': 'Participants received plitidepsin 2.5 mg/day intravenous (IV) in addition to dexamethasone on days 1 to 3.'}, {'id': 'OG001', 'title': 'Plitidepsin 1.5 mg Arm', 'description': 'Participants received plitidepsin 1.5 mg/day IV in addition to dexamethasone on days 1 to 3.'}, {'id': 'OG002', 'title': 'Control Arm', 'description': 'Participants received dexamethasone IV on Days 1 to 3. Additionally, in accordance with local treatment guidelines, patients in this group may have received a regulatory-approved antiviral treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From administration date to Day 31(±3)', 'description': 'Adverse Event Types according to the National Cancer Institute \\[NCI\\]-Common Terminology Criteria for AEs (CTCAE v.5.0):\n\nThe number of participants who experienced treatment-emergent adverse events (TEAEs) are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated Population'}, {'type': 'SECONDARY', 'title': 'Frequency of TEAEs of ≥Grade 3 According to NCI-CTCAE for Adverse Events (Version 5.0), TEAEs of Special Interest, Serious TEAEs, Serious Treatment-related TEAEs, TEAEs Leading to Treatment Discontinuation, and Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Plitidepsin 2.5 mg Arm', 'description': 'Participants received plitidepsin 2.5 mg/day intravenous (IV) in addition to dexamethasone on days 1 to 3.'}, {'id': 'OG001', 'title': 'Plitidepsin 1.5 mg Arm', 'description': 'Participants received plitidepsin 1.5 mg/day IV in addition to dexamethasone on days 1 to 3.'}, {'id': 'OG002', 'title': 'Control Arm', 'description': 'Participants received dexamethasone IV on Days 1 to 3. Additionally, in accordance with local treatment guidelines, participants in this group may have received a regulatory-approved antiviral treatment.'}], 'classes': [{'title': 'Any TEAE Grade ≥3', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE of special interest', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Any serious TEAE', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Any serious treatment-related TEAE to any study treatment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE leading to discontinuation of any study treatment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE leading to death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From administration date to Day 31(±3)', 'description': 'Frequency of treatment-emergent adverse events (TEAEs) of ≥grade 3 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 5.0), TEAEs of special interest, serious TEAEs, serious treatment-related TEAEs, TEAEs leading to treatment discontinuation, and deaths', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Plitidepsin 2.5 mg Arm', 'description': 'Participants received plitidepsin 2.5 mg/day intravenous (IV) in addition to dexamethasone on days 1 to 3.'}, {'id': 'FG001', 'title': 'Plitidepsin 1.5 mg Arm', 'description': 'Participants received plitidepsin 1.5 mg/day IV in addition to dexamethasone on days 1 to 3.'}, {'id': 'FG002', 'title': 'Control Arm', 'description': 'Participants received dexamethasone IV on Days 1 to 3. Additionally, in accordance with local treatment guidelines, participants in this group may have received a regulatory-approved antiviral treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Participant worsened, PI decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant deterioration becoming a candidate for treatment with TZB', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant admitted in other hospital due to a serious adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Did not meet all inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'The participant was transferred to IRCU', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'SAE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Discontinued as was found to be ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Plitidepsin 2.5 mg Arm', 'description': 'Participants received plitidepsin 2.5 mg/day intravenous (IV) in addition to dexamethasone on days 1 to 3.'}, {'id': 'BG001', 'title': 'Plitidepsin 1.5 mg Arm', 'description': 'Participants received plitidepsin 1.5 mg/day IV in addition to dexamethasone on days 1 to 3.'}, {'id': 'BG002', 'title': 'Control Arm', 'description': 'Participants received dexamethasone IV on Days 1 to 3. Additionally, in accordance with local treatment guidelines, participants in this group may have received a regulatory-approved antiviral treatment.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '58.9', 'spread': '13.33', 'groupId': 'BG000'}, {'value': '58.1', 'spread': '14.80', 'groupId': 'BG001'}, {'value': '59.3', 'spread': '15.02', 'groupId': 'BG002'}, {'value': '58.7', 'spread': '14.34', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '≥18 to 59 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}]}, {'title': '≥60 to 64 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}, {'title': '≥65 to 69 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': '≥70 to 74 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}, {'title': '≥75 to 79 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': '≥80 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '189', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Child-bearing potential, n (%)', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'No, surgically sterile/post-menopausal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}, {'title': 'No, other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only females. Percentages were calculated based on the number of females per group as the denominator'}, {'title': 'Height at screening', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '167.79', 'spread': '8.067', 'groupId': 'BG000'}, {'value': '169.56', 'spread': '8.534', 'groupId': 'BG001'}, {'value': '169.25', 'spread': '10.095', 'groupId': 'BG002'}, {'value': '168.87', 'spread': '8.921', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeter', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Height was not recorded for some participants.'}, {'title': 'Weight at screening', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '202', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '82.72', 'spread': '14.380', 'groupId': 'BG000'}, {'value': '86.05', 'spread': '19.778', 'groupId': 'BG001'}, {'value': '87.38', 'spread': '19.672', 'groupId': 'BG002'}, {'value': '85.36', 'spread': '18.120', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'weight was not recorded for some participants.'}, {'title': 'Body mass index at screening', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '29.45', 'spread': '4.555', 'groupId': 'BG000'}, {'value': '29.68', 'spread': '5.617', 'groupId': 'BG001'}, {'value': '30.26', 'spread': '6.116', 'groupId': 'BG002'}, {'value': '29.79', 'spread': '5.448', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'not recorded for some participants'}, {'title': 'Body mass index group at screening', 'classes': [{'title': '≥18.5 and <25 kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': '≥25 and <30 kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}]}, {'title': '≥30 and <35 kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}, {'title': '≥35 and <40 kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}, {'title': '≥40 kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body surface area at screening', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.922', 'spread': '0.1787', 'groupId': 'BG000'}, {'value': '1.961', 'spread': '0.2252', 'groupId': 'BG001'}, {'value': '1.968', 'spread': '0.2299', 'groupId': 'BG002'}, {'value': '1.950', 'spread': '0.2123', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'not recorded for some participants'}, {'title': 'Periods of inclusion', 'classes': [{'title': 'Beginning of accrual - August 2021', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'September 2021 - March 2022', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}]}]}, {'title': 'April 2022 - End of accrual', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Systolic blood pressure (mmHg) at screening', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '123.4', 'spread': '18.44', 'groupId': 'BG000'}, {'value': '126.9', 'spread': '16.25', 'groupId': 'BG001'}, {'value': '127.9', 'spread': '16.24', 'groupId': 'BG002'}, {'value': '126.1', 'spread': '17.04', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure (mmHg) at screening', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '74.2', 'spread': '9.53', 'groupId': 'BG000'}, {'value': '76.1', 'spread': '9.36', 'groupId': 'BG001'}, {'value': '75.0', 'spread': '11.26', 'groupId': 'BG002'}, {'value': '75.1', 'spread': '10.05', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pulse rate (beats/min) at screening', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '81.6', 'spread': '13.72', 'groupId': 'BG000'}, {'value': '83.9', 'spread': '11.36', 'groupId': 'BG001'}, {'value': '84.2', 'spread': '13.50', 'groupId': 'BG002'}, {'value': '83.2', 'spread': '12.88', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Temperature (C) at screening', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '204', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '36.91', 'spread': '0.878', 'groupId': 'BG000'}, {'value': '36.90', 'spread': '0.899', 'groupId': 'BG001'}, {'value': '36.92', 'spread': '0.875', 'groupId': 'BG002'}, {'value': '36.91', 'spread': '0.880', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'celsius', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data not available for all participants in this cohort'}, {'title': 'Respiration rate (breaths/min) at screening', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '202', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '19.5', 'spread': '3.49', 'groupId': 'BG000'}, {'value': '19.0', 'spread': '3.40', 'groupId': 'BG001'}, {'value': '19.9', 'spread': '3.32', 'groupId': 'BG002'}, {'value': '19.4', 'spread': '3.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'breaths/min', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data not available for all participants in this cohort'}, {'title': 'Oxygen saturation (%) at screening', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '204', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '96.29', 'spread': '1.779', 'groupId': 'BG000'}, {'value': '96.26', 'spread': '1.721', 'groupId': 'BG001'}, {'value': '96.44', 'spread': '1.749', 'groupId': 'BG002'}, {'value': '96.33', 'spread': '1.743', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data not available for all participants in this cohort'}, {'title': 'Fraction of inspired oxygen (%) at screening', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '26.92', 'spread': '3.861', 'groupId': 'BG000'}, {'value': '26.91', 'spread': '3.370', 'groupId': 'BG001'}, {'value': '27.94', 'spread': '9.526', 'groupId': 'BG002'}, {'value': '27.25', 'spread': '6.191', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Vaccination status', 'classes': [{'title': 'Fully vaccinated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}]}]}, {'title': 'Non-fully vaccinated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Not vaccinated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}, {'title': 'Fully vaccinated + Non-fully vaccinated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'SARS-CoV-2 viral load at Day 1', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5.02', 'spread': '1.880', 'groupId': 'BG000'}, {'value': '4.97', 'spread': '1.985', 'groupId': 'BG001'}, {'value': '5.06', 'spread': '2.253', 'groupId': 'BG002'}, {'value': '5.01', 'spread': '2.040', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Summary was based on full analysis set'}], 'populationDescription': 'Intent-to-treat population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-29', 'size': 1856421, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-21T07:57', 'hasProtocol': True}, {'date': '2023-04-21', 'size': 4889187, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-21T07:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients Will be randomised in 1:1:1 to: Plitidepsin 1.5 mg arm, Plitidepsin 2.5 mg arm and Control arm'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'whyStopped': 'Sponsor has decided to end the study prematurely based on significant difficulties in the recruitment of patients, despite the implementation of corrective measures that still failed to increase the accrual rate required for a feasible completion.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2021-03-04', 'resultsFirstSubmitDate': '2024-02-22', 'studyFirstSubmitQcDate': '2021-03-04', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-29', 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Sustained Withdrawal of Supplementary Oxygen With no Subsequent Reutilisation During Remaining Study Period', 'timeFrame': 'From administration date to Day 31(±3)', 'description': 'Time to sustained withdrawal of oxygen supplementation (in days) with no subsequent reutilisation during remaining study period is defined as the first day, from randomisation through completion of the study, on which a patient i. satisfies categories 0 to 4 on the 11-point WHO Clinical Progression Scale, and ii. has no subsequent reutilisation of oxygen supplementation (5 to 10 on the 11-point WHO Clinical Progression Scale).\n\nThe WHO clinical progression scale provides a measure of illness severity across a range from 0 (uninfected) to 10 (dead).'}], 'secondaryOutcomes': [{'measure': 'Time to Sustained (i.e., With no Subsequent Readmission to Day 31) Hospital Discharge (Since Randomisation).', 'timeFrame': 'From administration date to Day 31(±3)', 'description': 'Time to sustained (i.e., with no subsequent readmission to Day 31) hospital discharge (since randomization)'}, {'measure': 'Clinical Status by the 11-category WHO Clinical Progression Scale on Day 8', 'timeFrame': 'Day 8 (±1)', 'description': 'The WHO clinical progression scale provides a measure of illness severity across a range from 0 (uninfected) to 10 (dead).\n\n0 = Uninfected; no viral RNA detected\n\n1. = Ambulatory mild disease. Asymptomatic; viral RNA detected\n2. = Ambulatory mild disease. Symptomatic; independent\n3. = Ambulatory mild disease. Symptomatic; assistance needed\n4. = Hospitalized: moderate disease. Hospitalized; no oxygen therapy\n5. = Hospitalized: moderate disease. Hospitalized; oxygen by mask or nasal prongs\n6. = Hospitalized: severe diseases. Hospitalized; oxygen by NIV or high flow\n7. = Hospitalized: severe diseases. Intubation and mechanical ventilation pO2/FIO2 \\> 150 or SpO2/FIO2 \\> 200\n8. = Hospitalized: severe diseases. Mechanical ventilation pO2 /FIO2 \\<150 (SpO2 /FiO2 \\<200) or vasopressors\n9. = Hospitalized: severe diseases. Mechanical ventilation pO2 /FiO2 \\<150 and vasopressors, dialysis, or ECMO\n10. = dead'}, {'measure': 'Total Duration of Advanced Oxygen Support', 'timeFrame': 'From administration date to Day 31(±3)', 'description': 'Total duration of advanced oxygen support (high-flow nasal oxygen, extracorporeal membrane oxygenation -ECMO-, non-invasive ventilation or mechanical ventilation).'}, {'measure': 'Number of Participants in Each Study Group Requiring Admission to ICU', 'timeFrame': 'Day 4, Day 8(±1) , Day 15(±1) and Day 31(±3)', 'description': 'Number of participants in each study group requiring admission to intensive care unit'}, {'measure': 'Frequency of Adverse Events', 'timeFrame': 'From administration date to Day 31(±3)', 'description': 'Adverse Event Types according to the National Cancer Institute \\[NCI\\]-Common Terminology Criteria for AEs (CTCAE v.5.0):\n\nThe number of participants who experienced treatment-emergent adverse events (TEAEs) are presented.'}, {'measure': 'Frequency of TEAEs of ≥Grade 3 According to NCI-CTCAE for Adverse Events (Version 5.0), TEAEs of Special Interest, Serious TEAEs, Serious Treatment-related TEAEs, TEAEs Leading to Treatment Discontinuation, and Deaths', 'timeFrame': 'From administration date to Day 31(±3)', 'description': 'Frequency of treatment-emergent adverse events (TEAEs) of ≥grade 3 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 5.0), TEAEs of special interest, serious TEAEs, serious treatment-related TEAEs, TEAEs leading to treatment discontinuation, and deaths'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Infection']}, 'referencesModule': {'references': [{'pmid': '39182994', 'type': 'DERIVED', 'citation': 'Landete P, Caliman-Sturdza OA, Lopez-Martin JA, Preotescu L, Luca MC, Kotanidou A, Villares P, Iglesias SP, Guisado-Vasco P, Saiz-Lou EM, Del Carmen Farinas-Alvarez M, de Lucas EM, Perez-Alba E, Cisneros JM, Estrada V, Hidalgo-Tenorio C, Poulakou G, Torralba M, Fortun J, Garcia-Ocana P, Lemaignen A, Marcos-Martin M, Molina M, Paredes R, Perez-Rodriguez MT, Raev D, Ryan P, Meira F, Gomez J, Torres N, Lopez-Mendoza D, Jimeno J, Varona JF. A Phase III Randomized Controlled Trial of Plitidepsin, a Marine-Derived Compound, in Hospitalized Adults With Moderate COVID-19. Clin Infect Dis. 2024 Oct 15;79(4):910-919. doi: 10.1093/cid/ciae227.'}]}, 'descriptionModule': {'briefSummary': 'Treatment of patients hospitalised for management of moderate COVID-19 infection', 'detailedDescription': 'This is a multicentre, open-label, controlled Phase 3 study in which adults requiring hospital admission and O2 supplementation for management of moderate COVID-19 infection will be randomised in 1:1:1 to: Plitidepsin 1.5 mg arm, Plitidepsin 2.5 mg arm and Control arm'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed informed consent obtained prior to initiation of any study-specific procedures and study treatment.\n2. Documented diagnosis of SARS-CoV-2 infection, determined by either qualitative polymerase chain reaction (PCR), antigen test by local laboratory, or any other validated method approved by the local health authority, from appropriate biological samples collected no more than 72 hours prior to study treatment on Day 1.\n3. Patient meets category 5 on the 11-point WHO Clinical Progression Scale: requires hospitalisation and oxygen by mask or nasal prongs/cannula.\n4. A maximum of 14 days from onset of COVID-19 symptoms to initiation of study treatment on Day 1.\n5. Male or female aged ≥18 years.\n6. Adequate bone marrow, liver, kidney, and metabolic function, defined by the following tests performed at local laboratory:\n\n * Absolute neutrophil count ≥500/mm\\^3 (0.5 x 10\\^9/L).\n * Platelet count ≥75,000/mm\\^3 (75 x 10\\^9/L).\n * Alanine transaminase (ALT), aspartate transaminase (AST) ≤3 x upper limit of normal (ULN).\n * Serum bilirubin ≤1 x ULN (or direct bilirubin \\<1 x ULN when total bilirubin is above ULN).\n * Calculated creatinine clearance ≥30 mL/min (Cockcroft-Gault equation).\n * Creatine phosphokinase (CPK) ≤2.5 x ULN except if the patient has had recent (i.e., in the last week) shivering episodes or trauma. In that case, the level of CPK should be ≤5 x ULN.\n7. Agree not to participate in another interventional clinical trial through Day 31.\n8. Females of reproductive capacity must have a negative serum or urine pregnancy test by local laboratory at study enrolment and must be non-lactating.\n9. Females and males with partners of child-bearing potential must use effective contraception while on study treatment and for 6 months after last dose of plitidepsin. Patients in the control arm must use effective contraception during the time indicated in the approved product information (summary of product characteristics \\[SmPC\\] or leaflet). If no information is available in the approved product information, patients in the control arm must use effective contraception for at least one week after the study completion or the time indicated based on the investigator's discretion.\n\nExclusion Criteria:\n\n1. Subjects with a pre-baseline (i.e., in the month preceding the current COVID-19 infection) impairment in general health condition for whatever reason except COVID-19, with a severe dependency for daily living activities (Barthel index ≤ 60/100) or chronic oxygen therapy.\n2. Having received treatment for COVID-19 in another clinical trial in the prior 4 weeks, except documented allocation in a placebo arm.\n3. Evidence of respiratory failure at the time of randomisation, based on resource utilisation requiring at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, non-invasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the aforementioned therapies, which could not be administered in a resource-limited setting).\n4. Patients with severe COVID-19, meeting score \\>5 on the 11-point WHO Clinical Progression Scale or presenting, after an initial stabilisation prior to randomisation, any of clinical signs indicative of severe systemic illness, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, or PaO2/FiO2 \\<300. In case a direct measure of PaO2 has not been obtained, it should be imputed according to a referenced formula. For sites located over 1000 m above sea level, PaO2/FiO2 ratio will be adjusted.\n5. Patients receiving, at randomisation, treatment with antiviral therapy against SARS-CoV-2 or requiring anti-inflammatory/immunomodulating drugs beyond glucocorticoids with the exceptions listed below:\n\n * Prior administration of dexamethasone or equivalent glucocorticoid might be acceptable if:\n\n 1. The total daily dose is not higher than 10 mg of dexamethasone phosphate (equivalent to dexamethasone base 8.25 mg/day) or equivalent glucocorticoids.\n 2. The duration of the treatment does not exceed 72 hours prior to study treatment Day 1.\n * Prior administration of dexamethasone or equivalent glucocorticoid might be acceptable if:\n\n 1. The total daily dose is not higher than 10 mg of dexamethasone phosphate (equivalent to dexamethasone base 8.25 mg/day) or equivalent glucocorticoids.\n 2. The duration of the treatment does not exceed 72 hours prior to study treatment Day 1.\n * Prior administration of an antiviral might be acceptable in the following circumstances:\n\n 1. For small molecules (e.g., remdesivir, molnupiravir, nirmaltrevir/ritonavir), they must have been given for an earlier stage of the disease, outside a clinical trial, and there should be a documentation of objective clinical deterioration plus evidence of persisting positivity for SARS-CoV-2 in appropriate biological samples. Last dose of previous antiviral drugs should have been administered at least 24 h before randomisation.\n 2. For antiviral monoclonal antibodies, they must have been given for an earlier stage of the disease (including pre-exposure prophylaxis), outside a clinical trial, and there should be a documentation of objective clinical deterioration plus evidence of persisting positivity for SARS-CoV-2 in appropriate biological samples. Last dose of antiviral monoclonal antibodies should have been administered at least 1 week before randomisation.\n6. Patients receiving treatment with chloroquine or derivatives within 8 weeks before enrolment or during the study.\n7. Patients receiving treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers.\n8. Viral illness (other than COVID-19) requiring therapy, except for patients with treated and adequately controlled (undetectable) human immunodeficiency virus infection.\n9. Patients with uncontrolled known primary or secondary immunodeficiency, including chronic treatment with glucocorticoids (i.e., prednisone at a daily dose of \\>10 mg for \\>1 month, or another glucocorticoid at equipotent dose).\n10. Any of the following cardiac conditions or risk factors:\n\n * Sinus bradycardia (\\<50 beats/min), sinus nodal dysfunction (sick sinus disease), atrioventricular block of any degree (PR \\>200 msec), or any other bradyarrhythmia (\\<50 beats/min), except for patients with permanent pacemakers;\n * Cardiac infarction, cardiac surgery or cardiac insufficiency episode within the last 6 months;\n * Known abnormal value of left ventricular ejection fraction (LVEF \\<low limit of normal (LLN)), unless documented confirmation of recovery (LVEF \\>LLN) in the previous month;\n * QT interval corrected using Fridericia's formula (QTcF) \\>450 msec for males or \\>470 msec for females;\n * History of known congenital or acquired QT prolongation;\n * Uncorrected hypokalaemia, hypocalcaemia (adjusted) and/or hypomagnesemia at screening;\n * Troponin test performed at local laboratory \\>1.5 x ULN; or\n * Need for an unreplaceable drug that prolongs QT and it is clearly associated with a known risk for torsades de pointes (TdP); in case of being already on treatment with these aforementioned drugs, a minimum of 4 half-lives of the drug is required before replacement (if feasible).\n11. Hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol) or patients for whom dexamethasone, antihistamine H1/H2 or antiserotoninergic agents are contraindicated.\n12. Females who are pregnant (negative serum or urine pregnancy test required for all females of child-bearing potential at screening) or breast feeding.\n13. Females and males with partners of child-bearing potential (females who are not surgically sterile or postmenopausal defined as amenorrhea for \\>12 months) who are not using at least 1 protocol specified method of contraception.\n14. Any other clinically significant medical condition (including major surgery within the last 3 weeks before screening) or laboratory abnormality that, in the opinion of the investigator, would jeopardise the safety of the patient or potentially impact on patient compliance or the safety/efficacy observations in the study."}, 'identificationModule': {'nctId': 'NCT04784559', 'acronym': 'Neptuno', 'briefTitle': 'Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'PharmaMar'}, 'officialTitle': 'A Phase 3, Multicentre, Randomised, Controlled Trial to Determine the Efficacy and Safety of Two Dose Levels of Plitidepsin Versus Control in Adult Patient Requiring Hospitalisation for Management of Moderate COVID-19 Infection', 'orgStudyIdInfo': {'id': 'APL-D-003-20'}, 'secondaryIdInfos': [{'id': '2020-005951-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Plitidepsin 1.5 mg arm', 'description': 'Patients will receive plitidepsin 1.5 mg/day intravenous (IV) in addition to dexamethasone on days 1 to 3.', 'interventionNames': ['Drug: Plitidepsin', 'Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Plitidepsin 2.5 mg arm', 'description': 'Patients will receive plitidepsin 2.5 mg/day IV in addition to dexamethasone on days 1 to 3.', 'interventionNames': ['Drug: Plitidepsin', 'Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'description': 'Patients will receive dexamethasone IV on Days 1 to 3. Additionally, in accordance with local treatment guidelines, patients in this group may receive a regulatory-approved antiviral treatment.', 'interventionNames': ['Drug: Dexamethasone', 'Drug: Remdesivir', 'Drug: Favipiravir']}], 'interventions': [{'name': 'Plitidepsin', 'type': 'DRUG', 'description': 'Plitidepsin 2 mg powder is provided as a sterile, preservative-free, and white to off-white lyophilised powder/cake comprising 2 mg plitidepsin and mannitol in a single-dose, 10 mL clear type 1 glass vial.\n\nSolvent for plitidepsin is provided as a sterile, preservative-free, clear, slightly viscous aqueous liquid (4 mL) containing macrogolglycerol ricinoleate and ethanol in a single-dose type 1 clear glass ampoule.\n\nFor administration, vial contents are reconstituted by addition of 4 mL of solvent for plitidepsin to obtain a slightly yellowish solution containing 0.5 mg/mL plitidepsin with mannitol, macrogolglycerol ricinoleate and ethanol excipients. The required amount of plitidepsin reconstituted solution is added to bag containing 0.9% sodium chloride or 5% glucose for IV injection and administered as an IV infusion over 60 minutes.', 'armGroupLabels': ['Plitidepsin 1.5 mg arm', 'Plitidepsin 2.5 mg arm']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Detailed information about the formulation, posology, packaging and labelling, storage, and manufacturer is provided in the current country-specific product information. The summary of product characteristics (SmPC) and/or leaflet provides detailed product information for investigators in the European Union and/or in other regions.', 'armGroupLabels': ['Control arm', 'Plitidepsin 1.5 mg arm', 'Plitidepsin 2.5 mg arm']}, {'name': 'Remdesivir', 'type': 'DRUG', 'description': 'Detailed information about the formulation, posology, packaging and labelling, storage, and manufacturer is provided in the current country-specific product information. The summary of product characteristics (SmPC) and/or leaflet provides detailed product information for investigators in the European Union and/or in other regions.', 'armGroupLabels': ['Control arm']}, {'name': 'Favipiravir', 'type': 'DRUG', 'description': 'Detailed information about the formulation, posology, packaging and labelling, storage, and manufacturer is provided in the current country-specific product information. The summary of product characteristics (SmPC) and/or leaflet provides detailed product information for investigators in the European Union and/or in other regions.', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30110-934', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital Felicio Rocho', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '1570', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': '"MHAT "Sveta Anna"" - Sofia AD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '80020', 'city': 'Barranquilla', 'state': 'Atlántico', 'country': 'Colombia', 'facility': 'Clínica de la Costa Ltda.', 'geoPoint': {'lat': 10.96854, 'lon': -74.78132}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Centre Hospitalier Regional et Universitaire de Tours (CHRU Tours) - Hopital Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '106 76', 'city': 'Athens', 'country': 'Greece', 'facility': 'Evangelismos Hospital General Hospital of Athens Evangelismos, Intensive Care Unit', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '115 27', 'city': 'Athens', 'country': 'Greece', 'facility': 'Sotiria Hospital General Hospital of Chest Diseases of Athens "Sotiria" 3rd Department of Internal Medicine of University of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Universidad Autonoma de Nuevo Leon - Hospital Universitario "Dr. Jose Eleuterio Gonzalez"', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '021105', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Institutul National De Boli Infectioase "Prof. Dr. Matei Bals"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '030303', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor Babes - Bucharest', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '700116', 'city': 'Iași', 'country': 'Romania', 'facility': 'Spitalul Clinic De Boli Infectioase "Sfanta Parascheva" IASI, Sectia Boli Infectioase III', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '720237', 'city': 'Suceava', 'country': 'Romania', 'facility': "Spitalul Judetean de Urgenta 'Sf. Ioan cel Nou' Suceava, Sectia de Boli Infectioase", 'geoPoint': {'lat': 47.63333, 'lon': 26.25}}, {'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '11407', 'city': 'Jerez de la Frontera', 'state': 'Cádiz', 'country': 'Spain', 'facility': 'Hospital Universitario de Jerez de la Frontera', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'zip': '28668', 'city': 'Boadilla del Monte', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario HM Montepríncipe', 'geoPoint': {'lat': 40.405, 'lon': -3.87835}}, {'zip': '28223', 'city': 'Pozuelo de Alarcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Quirónsalud Madrid', 'geoPoint': {'lat': 40.43293, 'lon': -3.81338}}, {'zip': '36213', 'city': 'Vigo', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'Hospital Álvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '3010', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '18014', 'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de las Nieves (HUVN)', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '19002', 'city': 'Guadalajara', 'country': 'Spain', 'facility': 'Hospital Universitario de Guadalajara', 'geoPoint': {'lat': 40.62862, 'lon': -3.16185}}, {'zip': '28032', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infanta Leonor', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'H. HM Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28055', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital de Emergencias Enfermera Isabel Zendal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Instituto de Investigación Sanitaria Valdecilla (IDIVAL)', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'José Jimeno Doñaque, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'PharmaMar'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PharmaMar', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}