Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-27 @ 10:32 PM
Study NCT ID:
NCT04516759
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2020-08-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'C564219', 'term': 'Maturity-Onset Diabetes of the Young, Type 2'}], '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'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576407', 'term': 'AZD1656'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mike@sgscapital.org', 'phone': '+447768335460', 'title': 'Mike Johnson, Managing Director', 'organization': 'St George Street Capital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation (up to a maximum of 28 days).', 'description': 'Serious and other Adverse Events were assessed using the Safety Set (SAF) dataset. The SAF dataset included 84 patients in the AZD1656 arm and 69 patients in the placebo arm, All-Cause Mortality was assessed using the Full Analysis Set (FAS) dataset. The FAS dataset included 80 patients in the AZD1656 arm and 73 patients in the placebo arm.', 'eventGroups': [{'id': 'EG000', 'title': 'AZD1656 (Plus Usual Hospital Care)', 'description': '50mg film-coated tablets at a dose of 100mg BID\n\nAZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 80, 'otherNumAffected': 43, 'seriousNumAtRisk': 84, 'deathsNumAffected': 4, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Matched Placebo (Plus Usual Hospital Care)', 'description': 'Matched placebo tablets\n\nPlacebo: Matched placebo tablets', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 73, 'otherNumAffected': 17, 'seriousNumAtRisk': 69, 'deathsNumAffected': 9, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vitamin D decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Leucocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neutrophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Reversible ischaemic neurological deficit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hepatitis toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oral fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abcess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sepsis', 'notes': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Improvement by Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1656 (Plus Usual Hospital Care)', 'description': '50mg film-coated tablets at a dose of 100mg BID\n\nAZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)'}, {'id': 'OG001', 'title': 'Matched Placebo (Plus Usual Hospital Care)', 'description': 'Matched placebo tablets\n\nPlacebo: Matched placebo tablets'}], 'classes': [{'title': 'Treatment responder', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Treatment failure', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1854', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.32', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Chi-squared test on the one-sided significance level of 2.5%'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 14', 'description': 'The World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement (OSCI) was used to measure Clinical Improvement at Day 14 versus baseline, comparing AZD1656 treatment with placebo. The WHO OSCI score ranges from 0-8 (0 = no symptoms, 8 = death). The higher the score the worse the condition of the patient.\n\nResults are presented as number of responders. Patients who were assigned a WHO score of 1, 2 or 3 at Day 14 were considered a treatment responder. A patient who was discharged before Day 14 was also considered a responder. All other patients (WHO scores 4-8 at Day 14) were considered treatment failures.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all participants who received at least one dose of treatment'}, {'type': 'SECONDARY', 'title': 'Clinical Improvement at Day 7, 14 and 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1656 (Plus Usual Hospital Care)', 'description': '50mg film-coated tablets at a dose of 100mg BID\n\nAZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)'}, {'id': 'OG001', 'title': 'Matched Placebo (Plus Usual Hospital Care)', 'description': 'Matched placebo tablets\n\nPlacebo: Matched placebo tablets'}], 'classes': [{'title': 'Baseline', 'categories': [{'title': 'Score 1: Ambulatory - no limitation of activities', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 2: Ambulatory - limitation of activities', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 3: Hospitalized, no oxygen therapy', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Score 4: Hospitalized, oxygen by mask or nasal prongs', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Score 5: Hospitalized, non-invasive ventilation or high-flow oxygen', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Score 6: Hospitalized, intubation or mechanical ventilation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 7: Hospitalized, ventilation + additional organ support - pressors, RTT, ECMO', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 8: Death', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'title': 'Score 1: Ambulatory - no limitation of activities', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Score 2: Ambulatory - limitation of activities', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Score 3: Hospitalized, no oxygen therapy', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Score 4: Hospitalized, oxygen by mask or nasal prongs', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'Score 5: Hospitalized, non-invasive ventilation or high-flow oxygen', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Score 6: Hospitalized, intubation or mechanical ventilation', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Score 7: Hospitalized, ventilation + additional organ support - pressors, RTT, ECMO', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 8: Death', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'title': 'Score 1: Ambulatory - no limitation of activities', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Score 2: Ambulatory - limitation of activities', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'title': 'Score 3: Hospitalized, no oxygen therapy', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Score 4: Hospitalized, oxygen by mask or nasal prongs', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Score 5: Hospitalized, non-invasive ventilation or high-flow oxygen', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Score 6: Hospitalized, intubation or mechanical ventilation', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Score 7: Hospitalized, ventilation + additional organ support - pressors, RTT, ECMO', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 8: Death', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'categories': [{'title': 'Score 1: Ambulatory - no limitation of activities', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Score 2: Ambulatory - limitation of activities', 'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Score 3: Hospitalized, no oxygen therapy', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 4: Hospitalized, oxygen by mask or nasal prongs', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Score 5: Hospitalized, non-invasive ventilation or high-flow oxygen', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Score 6: Hospitalized, intubation or mechanical ventilation', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Score 7: Hospitalized, ventilation + additional organ support - pressors, RTT, ECMO', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 8: Death', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Study Drug Discontinuation (SDD)', 'categories': [{'title': 'Score 1: Ambulatory - no limitation of activities', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Score 2: Ambulatory - limitation of activities', 'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Score 3: Hospitalized, no oxygen therapy', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 4: Hospitalized, oxygen by mask or nasal prongs', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Score 5: Hospitalized, non-invasive ventilation or high-flow oxygen', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Score 6: Hospitalized, intubation or mechanical ventilation', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Score 7: Hospitalized, ventilation + additional organ support - pressors, RTT, ECMO', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 8: Death', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0286', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Baseline p-value', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'one-side significance level of 2.5%'}, {'pValue': '0.0786', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 7 p-value', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'one-side significance level of 2.5%'}, {'pValue': '0.2169', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 14 p-value', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'one-side significance level of 2.5%'}, {'pValue': '0.1860', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Day 21 p-value', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'one-sided significance level of 2.5%'}, {'pValue': '0.2256', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Study Drug Discontinuation (SDD) p-value', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'one-sided significance level of 2.5%'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 21', 'description': 'The World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement (OSCI) was used to measure Clinical Improvement at Day 7, Day 14 and Day 21 versus baseline, comparing AZD1656 treatment with placebo.\n\nResults are presented as the percentage of patients categorised at each severity rating at each timepoint on the WHO 8-point OSCI scale.\n\nThe WHO OSCI score ranges from 0-8 (0 = no symptoms, 8 = death). The higher the score the worse the condition of the patient.\n\nStudy Drug Discontinuation was the date on which a patient discontinued treatment. Treatment was given for a maximum of 21 days, or until date of hospital discharge (WHO score 1 or 2), or date mechanical ventilation was required (WHO score 6 or 7) or until date of death (WHO score 8).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all participants who received at least one dose of treatment'}, {'type': 'SECONDARY', 'title': 'Glycaemic Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1656 (Plus Usual Hospital Care)', 'description': '50mg film-coated tablets at a dose of 100mg BID\n\nAZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)'}, {'id': 'OG001', 'title': 'Matched Placebo (Plus Usual Hospital Care)', 'description': 'Matched placebo tablets\n\nPlacebo: Matched placebo tablets'}], 'classes': [{'title': 'Increase in Diabetic Medication Needed equal or More Than 3 Days', 'categories': [{'title': 'True', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'False', 'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Diabetic Medication is Stable/Reduced Equal or More Than 3 days', 'categories': [{'title': 'True', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}, {'title': 'False', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Increase in Diabetic Medication Needed at Any Time During the Study', 'categories': [{'title': 'True', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'False', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Diabetic Medication is Stable/Reduced at Any Time During the Study', 'categories': [{'title': 'True', 'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}, {'title': 'False', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4006', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Increase in Diabetic Medication needed equal or more than 3 days', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.7482', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Diabetic Medication is stable/reduced equal or more than 3 days', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.6949', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Increase in Diabetic Medication needed at any time during the study', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.5521', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Diabetic Medication is stable/reduced at any time during the study', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 21', 'description': 'Degree of glycaemic control as measured by the need to increase baseline medication requirements or the need to add additional diabetic medications to maintain appropriate blood glucose levels in patients receiving AZD1656 compared with placebo', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all participants who at least received one dose of treatment'}, {'type': 'SECONDARY', 'title': 'Occurrence of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1656 (Plus Usual Hospital Care)', 'description': '50mg film-coated tablets at a dose of 100mg BID\n\nAZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)'}, {'id': 'OG001', 'title': 'Matched Placebo (Plus Usual Hospital Care)', 'description': 'Matched placebo tablets\n\nPlacebo: Matched placebo tablets'}], 'classes': [{'title': 'TEAEs leading to study drug discontinuation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Other TEAEs', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5875', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 28', 'description': 'Proportion of Treatment Emergent Adverse Events (TEAEs) leading to study drug discontinuation in patients receiving AZD1656 compared with placebo', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes all participants who received at least one dose of treatment and had at least one post-baseline safety assessment (where the statement that a patient had no AE on the AE eCRF constitutes a safety assessment). 4 patients from the placebo arm are moved to the AZD1656 arm due to having drug in their PK samples. The assignment of patients to the treatment groups are as actually treated.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1656 (Plus Usual Hospital Care)', 'description': '50mg film-coated tablets at a dose of 100mg BID\n\nAZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)'}, {'id': 'OG001', 'title': 'Matched Placebo (Plus Usual Hospital Care)', 'description': 'Matched placebo tablets\n\nPlacebo: Matched placebo tablets'}], 'classes': [{'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Other AEs', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1129', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 28', 'description': 'Proportion of Serious Adverse Events (SAEs) in patients receiving AZD1656 compared with placebo', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes all patients who received at least one dose of IMP and had at least one post-baseline safety assessment (where the statement that a patient had no AE on the AE eCRF constitutes a safety assessment). 4 patients from the placebo arm are moved to the AZD1656 arm due to having drug in their PK samples. The assignment of patients to the treatment groups are as actually treated.'}, {'type': 'SECONDARY', 'title': 'Duration of Hospitalisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1656 (Plus Usual Hospital Care)', 'description': '50mg film-coated tablets at a dose of 100mg BID\n\nAZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)'}, {'id': 'OG001', 'title': 'Matched Placebo (Plus Usual Hospital Care)', 'description': 'Matched placebo tablets\n\nPlacebo: Matched placebo tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '264.3', 'groupId': 'OG000', 'lowerLimit': '215.5', 'upperLimit': '299.7'}, {'value': '288.7', 'groupId': 'OG001', 'lowerLimit': '260.1', 'upperLimit': '307.1'}]}]}], 'analyses': [{'pValue': '0.1556', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to Day 21', 'description': 'Time from hospital admission to hospital discharge (in hours) in patients receiving AZD1656 compared with placebo', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all participant who at least received on dose of treatment'}, {'type': 'SECONDARY', 'title': 'Mortality Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1656 (Plus Usual Hospital Care)', 'description': '50mg film-coated tablets at a dose of 100mg BID\n\nAZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)'}, {'id': 'OG001', 'title': 'Matched Placebo (Plus Usual Hospital Care)', 'description': 'Matched placebo tablets\n\nPlacebo: Matched placebo tablets'}], 'classes': [{'categories': [{'title': 'Died', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Did not die', 'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0903', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '0.13', 'ciUpperLimit': '1.26', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'statisticalComment': "The p-value is assessed by means of an Fisher's exact test on the one-sided significance level of 2.5%"}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 28', 'description': 'Mortality rate in patients receiving AZD1656 compared with placebo.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intubation/Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1656 (Plus Usual Hospital Care)', 'description': '50mg film-coated tablets at a dose of 100mg BID\n\nAZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)'}, {'id': 'OG001', 'title': 'Matched Placebo (Plus Usual Hospital Care)', 'description': 'Matched placebo tablets\n\nPlacebo: Matched placebo tablets'}], 'classes': [{'categories': [{'title': 'Receiving Intubation/Mechanical Ventilation', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Not Receiving Intubation/Mechanical Ventilation', 'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6144', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'One-sided significance level of 2.5%'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 21', 'description': 'Number of Patients Receiving Intubation/Mechanical Ventilation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all participants who at least received one dose of treatment'}, {'type': 'POST_HOC', 'title': 'Mortality Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1656 (Plus Usual Hospital Care)', 'description': '50mg film-coated tablets at a dose of 100mg BID\n\nAZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)'}, {'id': 'OG001', 'title': 'Matched Placebo (Plus Usual Hospital Care)', 'description': 'Matched placebo tablets\n\nPlacebo: Matched placebo tablets'}], 'classes': [{'categories': [{'title': 'Died', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Did not die', 'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0105', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'one-sided significance level of 2.5%'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Randomization to 168 hours post randomization', 'description': 'Mortality rate from randomization up to and including 168 hours post randomization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all participant who received at least one dose of treatment; patients who withdrew consent are categorised as missing'}, {'type': 'POST_HOC', 'title': 'Proportion of Patients Discharged up to and Including 168 Hours Having a WHO OSCI Rating of 1 or 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1656 (Plus Usual Hospital Care)', 'description': '50mg film-coated tablets at a dose of 100mg BID\n\nAZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)'}, {'id': 'OG001', 'title': 'Matched Placebo (Plus Usual Hospital Care)', 'description': 'Matched placebo tablets\n\nPlacebo: Matched placebo tablets'}], 'classes': [{'categories': [{'title': 'Discharged from hospital (within 168 hrs with WHO 1 or 2)', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Not discharged from Hospital (within 168 hrs with WHO 1 or 2)', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.062', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'one-sided significance level of 2.5%'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to and including 168 hours post randomization', 'description': 'Proportion of Patients Being Discharged From Hospital up to and Including 168 hrs Having WHO OSCI Rating of 1 or 2', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all participants who had at least one dose of treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD1656 (Plus Usual Hospital Care)', 'description': '50mg film-coated tablets at a dose of 100mg BID\n\nAZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)'}, {'id': 'FG001', 'title': 'Matched Placebo (Plus Usual Hospital Care)', 'description': 'Matched placebo tablets\n\nPlacebo: Matched placebo tablets'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'excluding 2 subjects who were randomized but did not start treatment', 'groupId': 'FG000', 'numSubjects': '80'}, {'comment': 'excluding 1 subject who was randomized but did not start treatment', 'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '170 subjects were screened for participation. 13 subjects were screening failures. 156 subjects were randomized of which 3 subjects withdrew consent prior to start of study medication. 153 subjects started with study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD1656 (Plus Usual Hospital Care)', 'description': '50mg film-coated tablets at a dose of 100mg BID\n\nAZD1656: 50mg film-coated tablets (at daily dose of 100mg BID)'}, {'id': 'BG001', 'title': 'Matched Placebo (Plus Usual Hospital Care)', 'description': 'Matched placebo tablets\n\nPlacebo: Matched placebo tablets'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Romania', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'WHO OSCI rating', 'classes': [{'categories': [{'title': '3 - Hospitalised, no oxygen', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': '4 - Hospitalised, oxygen', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': '5 - Non-invasive ventilation or high flow oxygen', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients hospitalised with suspected or confirmed novel coronavirus (SARSCoV-2) infection, categorised as 3, 4 or 5 on the WHO Ordinal Scale for Clinical Improvement, were considered eligible for the trial. This score was clinically assessed by the treating physician at baseline. The WHO score ranges from 0-8 (0 = no symptoms, 8 = death). The higher the score the worse the condition of the patient is/was.', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes Type', 'classes': [{'categories': [{'title': 'Type 1', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Type 2', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Vitamin D group', 'classes': [{'categories': [{'title': '< 25 nmol/l', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': '>= 25 nmol/l', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-21', 'size': 1309357, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-03T05:17', 'hasProtocol': True}, {'date': '2021-07-27', 'size': 688032, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-03T05:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomised double-blind study. Eligible patients will be randomly assigned to one of two groups (AZD1656 plus usual care or placebo plus usual care) on a 1:1 basis'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2020-08-14', 'resultsFirstSubmitDate': '2022-04-12', 'studyFirstSubmitQcDate': '2020-08-16', 'lastUpdatePostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-21', 'studyFirstPostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Improvement by Day 14', 'timeFrame': 'Day 1 to Day 14', 'description': 'The World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement (OSCI) was used to measure Clinical Improvement at Day 14 versus baseline, comparing AZD1656 treatment with placebo. The WHO OSCI score ranges from 0-8 (0 = no symptoms, 8 = death). The higher the score the worse the condition of the patient.\n\nResults are presented as number of responders. Patients who were assigned a WHO score of 1, 2 or 3 at Day 14 were considered a treatment responder. A patient who was discharged before Day 14 was also considered a responder. All other patients (WHO scores 4-8 at Day 14) were considered treatment failures.'}], 'secondaryOutcomes': [{'measure': 'Clinical Improvement at Day 7, 14 and 21', 'timeFrame': 'Day 1 to Day 21', 'description': 'The World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement (OSCI) was used to measure Clinical Improvement at Day 7, Day 14 and Day 21 versus baseline, comparing AZD1656 treatment with placebo.\n\nResults are presented as the percentage of patients categorised at each severity rating at each timepoint on the WHO 8-point OSCI scale.\n\nThe WHO OSCI score ranges from 0-8 (0 = no symptoms, 8 = death). The higher the score the worse the condition of the patient.\n\nStudy Drug Discontinuation was the date on which a patient discontinued treatment. Treatment was given for a maximum of 21 days, or until date of hospital discharge (WHO score 1 or 2), or date mechanical ventilation was required (WHO score 6 or 7) or until date of death (WHO score 8).'}, {'measure': 'Glycaemic Control', 'timeFrame': 'Day 1 to Day 21', 'description': 'Degree of glycaemic control as measured by the need to increase baseline medication requirements or the need to add additional diabetic medications to maintain appropriate blood glucose levels in patients receiving AZD1656 compared with placebo'}, {'measure': 'Occurrence of Adverse Events', 'timeFrame': 'Day 1 to Day 28', 'description': 'Proportion of Treatment Emergent Adverse Events (TEAEs) leading to study drug discontinuation in patients receiving AZD1656 compared with placebo'}, {'measure': 'Occurrence of Serious Adverse Events', 'timeFrame': 'Day 1 to Day 28', 'description': 'Proportion of Serious Adverse Events (SAEs) in patients receiving AZD1656 compared with placebo'}, {'measure': 'Duration of Hospitalisation', 'timeFrame': 'Day 1 to Day 21', 'description': 'Time from hospital admission to hospital discharge (in hours) in patients receiving AZD1656 compared with placebo'}, {'measure': 'Mortality Rate', 'timeFrame': 'Day 1 to Day 28', 'description': 'Mortality rate in patients receiving AZD1656 compared with placebo.'}, {'measure': 'Intubation/Mechanical Ventilation', 'timeFrame': 'Day 1 to Day 21', 'description': 'Number of Patients Receiving Intubation/Mechanical Ventilation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Diabetes Mellitus', 'SARS-CoV-2', 'Regulatory T Cell', 'Glucokinase'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '35996565', 'type': 'DERIVED', 'citation': 'Chorlton J, Hollowood Z, Dyer C, Lockhart D, Boekman P, McCafferty K, Coffey P, Marelli-Berg F, Martin J. A randomised, double-blind, placebo-controlled, multicentre clinical trial of AZD1656 in diabetic patients hospitalised with COVID-19: The ARCADIA Trial - implications for therapeutic immune modulation. EClinicalMedicine. 2022 Sep;51:101604. doi: 10.1016/j.eclinm.2022.101604. Epub 2022 Aug 18.'}, {'pmid': '34853102', 'type': 'DERIVED', 'citation': 'McCafferty K, Hollowood Z, Allen M, Lockhart D, Chorlton J, Martin J. ARCADIA study protocol: a phase II, randomised, double-blind, placebo-controlled clinical trial to assess the safety and efficacy of AZD1656 in patients with diabetes hospitalised with suspected or confirmed COVID-19. BMJ Open. 2021 Dec 1;11(12):e049650. doi: 10.1136/bmjopen-2021-049650.'}]}, 'descriptionModule': {'briefSummary': 'The ARCADIA Trial is a randomised, double-blind, placebo-controlled clinical trial to assess the safety and efficacy of AZD1656 in patients with either Type 1 or Type 2 diabetes, hospitalised with COVID-19.', 'detailedDescription': "The ARCADIA Trial will assess the safety and efficacy of AZD1656 in 150 patients with either Type 1 or Type 2 diabetes who have been hospitalised with COVID-19.\n\nAZD1656 is a glucokinase (GK; hexokinase 4) activator which has been shown to reduce blood glucose for up to 4 months in humans. Diabetic patients admitted to hospital with COVID-19 often present with hyperglycaemia and are particularly vulnerable to progression to severe COVID-19. Treatment with AZD1656 (in addition to their usual care) may provide additional glucose control which could help improve clinical outcomes in both Type 1 and Type 2 diabetic populations.\n\nIn addition to its glucose lowering effect, AZD1656 may have additional benefits to COVID-19 patients via its effects on immune function. In many patients with severe COVID-19, an overreaction of the body's own immune system can cause severe problems including damage to the lungs and heart, which can lead to breathing problems necessitating intubation and ventilation. AZD1656 has been shown to activate the migration of T regulatory cells to sites of inflammation in preclinical experiments. This migration of Treg cells to inflamed tissue is crucial for their immune-modulatory function (Kishore et al (2017)). AZD1656 could enhance Treg migratory capacity and may prevent the development of cardiorespiratory complications observed in hospitalised patients with COVID-19, leading to lower requirements for oxygen therapy and assisted ventilation, and reduced incidences of pneumonia and acute respiratory distress syndrome (ARDS).\n\nDiabetic patients hospitalised with COVID-19 will be randomised to receive either AZD1656 tablets or placebo tablets on a 1:1 basis until they are discharged from hospital or until they require intubation/mechanical ventilation. The aim of the study is to determine whether AZD1656 improves clinical outcomes in diabetic patients hospitalised with COVID-19. The World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement will be used as the standard methodology for measuring patient outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or Female.\n2. Aged 18 and older.\n3. Have either Type I or Type II Diabetes Mellitus.\n4. Hospitalised with suspected or confirmed novel coronavirus (Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)) infection at time of enrolment, categorised as stage 3, 4 or 5 on the WHO Ordinal Scale for Clinical Improvement.\n5. Blood glucose level at or above 4 mmol/L.\n6. Able to take oral (tablet) formulation of medication.\n7. Patient is able to provide written informed consent prior to initiation of any study procedures.\n\nExclusion Criteria:\n\n1. In the opinion of the clinical team, progression to intubation or mechanical ventilation is imminent and inevitable, within the next 24 hours, irrespective of the provision of treatments.\n2. Patients admitted with primary suspected or proven Mycoplasma pneumoniae, Chlamydia pneumoniae and bacterial pneumonia, who acquired COVID-19 while hospitalized.\n3. Treatment with immunomodulators or anti-rejection drugs within the last 3 months.\n4. Pregnant or breast feeding.\n5. Men, and women of child-bearing potential, unwilling to use highly effective contraception during their participation in the trial and for 2 weeks after study completion.\n6. Anticipated transfer to another hospital which is not a study site within 72 hours.\n7. Known sensitivity to any of the study medication/placebo excipients.\n8. Prior dosing with AZD1656 on a previous clinical trial.\n9. Patients admitted as a result of and receiving immediate treatment for an acute asthmatic attack, acute myocardial infarction, acute cerebrovascular event.\n10. Any known non-COVID-19, non-diabetes related, serious condition which, in the opinion of the clinical team, makes the patient unsuitable for the trial.\n11. Known history of drug or alcohol abuse within previous 12 months of screening.\n12. Known history of HIV, hepatitis C or unresolved hepatitis B or severe liver disease.\n13. Current or planned use of gemfibrozil or any other strong inhibitors of CYP2C8.\n14. Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product (IMP) containing small molecule treatment(s) within 30 days or 5 half-lives (whichever is longer) prior to enrolment into this study, or containing biological treatment(s) within 3 months prior to entry into this study.'}, 'identificationModule': {'nctId': 'NCT04516759', 'acronym': 'ARCADIA', 'briefTitle': 'AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'St George Street Capital'}, 'officialTitle': 'A Phase II, Randomised, Double-blind, Placebo-controlled Clinical Trial to Assess the Safety and Efficacy of AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19', 'orgStudyIdInfo': {'id': 'SGS.1656.201'}, 'secondaryIdInfos': [{'id': '2020-002211-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD1656 (plus Usual Hospital Care)', 'description': '50mg film-coated tablets at a dose of 100mg BID', 'interventionNames': ['Drug: AZD1656']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matched Placebo (plus Usual Hospital Care)', 'description': 'Matched placebo tablets', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'AZD1656', 'type': 'DRUG', 'description': '50mg film-coated tablets (at daily dose of 100mg BID)', 'armGroupLabels': ['AZD1656 (plus Usual Hospital Care)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Matched placebo tablets', 'armGroupLabels': ['Matched Placebo (plus Usual Hospital Care)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brno', 'country': 'Czechia', 'facility': 'Masarykova Univerzita - Fakultni Nemocnice U SV Anny V Brne (308)', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Hořovice', 'country': 'Czechia', 'facility': 'Nemocnice Hořovice (309)', 'geoPoint': {'lat': 49.83597, 'lon': 13.90268}}, {'city': 'Kolín', 'country': 'Czechia', 'facility': 'Oblastni Nemocnice Kolín (306)', 'geoPoint': {'lat': 50.02806, 'lon': 15.1998}}, {'city': 'Mladá Boleslav', 'country': 'Czechia', 'facility': 'Klaudianova Nemonice (302)', 'geoPoint': {'lat': 50.41135, 'lon': 14.90318}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Fakultni Nemocnice V Motole (303)', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Thomayerova Nemonice (310)', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Třebíč', 'country': 'Czechia', 'facility': 'Nemocnice Třebíč (305)', 'geoPoint': {'lat': 49.21492, 'lon': 15.88166}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Colentina Clinical Hospital (204)', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Spitalul Clinic de Boli Infectioase Cluj-Napoca (203)', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca (202)', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Constanța', 'country': 'Romania', 'facility': 'Spitalul Clinic de Boli Infectioase Constanţa (207)', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}, {'city': 'Craiova', 'country': 'Romania', 'facility': 'Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr Victor Babes Craiova (206)', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Deva', 'country': 'Romania', 'facility': 'Spitalul Judetean de Urgenta Deva (208)', 'geoPoint': {'lat': 45.88333, 'lon': 22.9}}, {'city': 'Iași', 'country': 'Romania', 'facility': 'Spitalul Clinic de Boli Infectioase "Sfanta Parascheva" Iaşi (205)', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Timișoara', 'country': 'Romania', 'facility': 'Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr Victor Babes Timişoara (201)', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'city': 'Barnsley', 'country': 'United Kingdom', 'facility': 'Barnsley Hospital NHS Foundation Trust (105)', 'geoPoint': {'lat': 53.55, 'lon': -1.48333}}, {'city': 'Bolton', 'country': 'United Kingdom', 'facility': 'Bolton NHS Foundation Trust (122)', 'geoPoint': {'lat': 53.58333, 'lon': -2.43333}}, {'zip': 'BD9 6RJ', 'city': 'Bradford', 'country': 'United Kingdom', 'facility': 'Bradford Teaching Hospitals NHS Foundation Trust (103)', 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'zip': 'BS10 5NB', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'North Bristol NHS Trust (116)', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Darlington', 'country': 'United Kingdom', 'facility': 'County Durham and Darlington NHS Foundation Trust (121)', 'geoPoint': {'lat': 54.52429, 'lon': -1.55039}}, {'zip': 'DY1 2HQ', 'city': 'Dudley', 'country': 'United Kingdom', 'facility': 'The Dudley Group NHS Foundation Trust (107)', 'geoPoint': {'lat': 52.5, 'lon': -2.08333}}, {'zip': 'ME7 5NY', 'city': 'Gillingham', 'country': 'United Kingdom', 'facility': 'Medway NHS Foundation Trust (108)', 'geoPoint': {'lat': 51.38914, 'lon': 0.54863}}, {'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Hull & East Yorkshire NHS Trust (102)', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'E1 1FR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Barts Health NHS Trust (101 and 111)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free London NHS Foundation Trust (119)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "St George's University Hospitals NHS Foundation Trust (114)", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M6 8HD', 'city': 'Salford', 'country': 'United Kingdom', 'facility': 'Penine Acute Hospitals NHS Trust (106)', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'zip': 'S10 2SB', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Sheffield Hospitals NHS Foundation Trust (104)', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'TA1 5DA', 'city': 'Taunton', 'country': 'United Kingdom', 'facility': 'Somerset NHS Foundation Trust (109)', 'geoPoint': {'lat': 51.01494, 'lon': -3.10293}}, {'zip': 'WS2 9PS', 'city': 'Walsall', 'country': 'United Kingdom', 'facility': 'Walsall Healthcare NHS Trust (113)', 'geoPoint': {'lat': 52.58528, 'lon': -1.98396}}], 'overallOfficials': [{'name': 'Kieran McCafferty, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barts & The London NHS Trust'}]}, 'ipdSharingStatementModule': {'url': 'http://www.sgscapital.org', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Requests for access to the data will be accepted beginning 6 months after article publication and will continue to be accepted for up to 5 years after publication.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to deidentified individual participant data (IDP) that underlie the published clinical trial results.', 'accessCriteria': 'Researchers must submit a methodologically sound research proposal to St George Street using the contact details provided on our website. See link below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St George Street Capital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}