Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-25 @ 8:25 PM
Study NCT ID:
NCT02287467
Status:
COMPLETED
Last Update Posted:
2019-11-14
First Post:
2014-11-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rdavey@niaid.nih.gov', 'phone': '301-496-8029', 'title': 'Dr. Richard Davey', 'organization': 'NIAID'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '28 days', 'description': 'Serious adverse events plus all grade 3 and 4 adverse events, as graded according to the National Institute of Health Division of AIDS (DAIDS) toxicity table.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)', 'otherNumAtRisk': 156, 'deathsNumAtRisk': 156, 'otherNumAffected': 13, 'seriousNumAtRisk': 156, 'deathsNumAffected': 6, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline', 'otherNumAtRisk': 152, 'deathsNumAtRisk': 152, 'otherNumAffected': 14, 'seriousNumAtRisk': 152, 'deathsNumAffected': 5, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Internal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Retroperitoneal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Breast abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Enterococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Post lumbar puncture syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vocal cord paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dysthymic disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients in Each of 6 Clinical Status Categories on Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'title': 'Died', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized, in ICU', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Non-ICU hospitalization, using supplemental oxygen', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Non-ICU hospitalization, no supplemental oxygen', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Discharged, not back to normal activities', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Discharged, back to normal activities', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.33', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.97', 'estimateComment': 'Odds ratio is hIVIG vs. placebo. A value greater than 1 favors the hIVIG group.', 'groupDescription': 'Odds ratio of being in a better category, as assessed using a proportional odds model. Multiple imputation techniques were used to impute an outcome for 4 patients for whom the outcome was unknown.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline clinical status, region, and participation in the pilot study.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed on Day 7', 'description': 'This is the primary outcome, a 6-category ordinal outcome ranging from death (worst) to discharged from hospital with resumption of normal activities (best).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All infused participants, using multiple imputation to impute outcome for 4 participants with missing data.'}, {'type': 'SECONDARY', 'title': 'Number of Patients in Each of 5 Clinical Status Categories on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized, in ICU', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Non-ICU hospitalization, NEW score 3+', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Non-ICU hospitalization, NEW score < 3', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Discharged', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.84', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.48', 'estimateComment': 'Odds ratio is for hIVIG vs placebo. An odds ratio greater than 1 favors the hIVIG group.', 'groupDescription': 'Odds ratio for being in a better category, from a proportional odds model', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline clinical status, region, and participation in the pilot study.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed on Day 3', 'description': '5-category ordinal outcome assessed on day 3; clinical status ranges from death (worst) to discharged from the hospital (best).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'SECONDARY', 'title': 'Number of Patients in Each of 6 Clinical Status Categories on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized, in ICU', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Non-ICU hospitalization, on supplemental oxygen', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Non-ICU hospitalizaiton, no supplemental oxygen', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Discharged, not back to normal activities', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Discharged, back to normal activities', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.52', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.33', 'estimateComment': 'Odds ratio is for hIVIG vs. placebo. An odds ratio \\> 1 favors the hIVIG group.', 'groupDescription': 'Odds ratio for being in a better group, from a proportional odds model.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline clinical status, region, and participation in the pilot study.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured on Day 3', 'description': '6-category ordinal outcome evaluated on Day 3; clinical status ranges from death (worst) to discharged from hospital with resumption of normal activities (best).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with clinical data available on Day 3'}, {'type': 'SECONDARY', 'title': 'Number of Patients With a Favorable Outcome on Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'title': 'favorable outcome', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': 'unfavorable outcome', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.20', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '0.81', 'ciUpperLimit': '2.74', 'estimateComment': 'Odds ratio for hIVIG vs placebo. An odds ratio \\> 1.0 favors the hIVIG group.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline clinical status, region, and participation in the pilot study.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed on Day 7', 'description': 'Sliding dichotomy defined as non-ICU hospitalization or discharge if enrolled from ICU, and discharge if enrolled from the general ward.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'title': 'Discharged alive', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Not discharged alive', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.44', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '.85', 'ciUpperLimit': '1.45', 'estimateComment': 'hazard ratio is hIVIG vs placebo; a hazard ratio \\>1 favors the hIVIG group.', 'groupDescription': 'Deaths during hospitalization are censored after day 7.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by baseline clinical status, region, and participation in the pilot study.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Day 7', 'description': 'Number of participants alive and discharged from the hospital', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (hIVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for hIVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'title': 'Died', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Did not die', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.40', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.72', 'ciLowerLimit': '.48', 'ciUpperLimit': '6.15', 'estimateComment': 'hazard ratio is for hIVIG vs placebo; a hazard ratio \\< 1.0 favors the hIVIG group.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'stratified by baseline clinical status, region, and participation in pilot study'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through day 28', 'description': 'Number of participants dying through day 28.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Number of Patients Alive and Out of Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'categories': [{'title': 'Alive and out of hospital', 'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}, {'title': 'Died or hospitalized', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.74', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '.38', 'ciUpperLimit': '1.98', 'estimateComment': 'odds ratio is for hIVIG vs placebo; an odds ratio \\> 1.0 favors hIVIG', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline clinical status, region, and participation in pilot study'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Day 28', 'description': 'Number and percent alive and out of hospital on day 28', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with vital status known on Day 28'}, {'type': 'SECONDARY', 'title': 'Change in Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (hIVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for hIVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.99', 'spread': '.16', 'groupId': 'OG000'}, {'value': '-2.32', 'spread': '.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.49', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-.26', 'ciUpperLimit': '.54', 'estimateComment': 'Change is calculated as day 3 - baseline. Difference in changes is hIVIG - placebo.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline RNA, geographic region, and influenza subtype'}], 'paramType': 'MEAN', 'timeFrame': 'Day 3', 'description': 'Change in nasopharyngeal viral load from baseline to day 3', 'unitOfMeasure': 'log10 RNA', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with viral load results at both baseline and day 3. Participants with undetectable viral load results at baseline are excluded.'}, {'type': 'SECONDARY', 'title': 'Death or Re-hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (hIVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.93', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.97', 'estimateComment': 'Odds ratio is for hIVIG vs placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline clinical status, region, and participation in pilot study.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28', 'description': 'Number and percent of participants who died or were re-hospitalized after initial discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants with data'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Developing Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.81', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.82', 'estimateComment': 'odds ratio is for hIVIG group vs placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline clinical status, region, and participation in pilot study'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Day 28', 'description': 'Number and percent of participants developing respiratory distress syndrome, acute renal failure, sepsis, pneumonia, enteritis, or bronchitis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Number of Patients in Each of 6 Clinical Status Categories on Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'categories': [{'title': 'Died', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Hospitalized in ICU', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Hospitalized on supplement oxygen', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Hospitalized not on supplemental oxygen', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Discharged, not back to normal activities', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Discharged, back to normal activities', 'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.55', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.95', 'estimateComment': 'Odds ratio (hIVIG vs placebo) of being in a better category. An odds ratio \\> 1 favors the hIVIG group.', 'groupDescription': 'Proportional odds for being in a better category', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline clinical status, region, and participation in the pilot study'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured on day 14', 'description': '6-category ordinal outcome measured on day 14', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants with observed data on day 14'}, {'type': 'SECONDARY', 'title': 'Number of Patients Alive and Out of Hospital on Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.77', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '.5', 'ciUpperLimit': '2.31', 'estimateComment': 'odds ratio is for hIVIG vs placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline clinical status, region, and participation in pilot study'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 14', 'description': 'Number and percentage of participants alive and out of the hospital on Day 14', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants'}, {'type': 'SECONDARY', 'title': 'Resumption of Normal Activities by Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (hIVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for hIVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.34', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '0.7', 'ciUpperLimit': '2.34', 'estimateComment': 'odds ratio is expressed as hIVIG vs placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline clinical status, region, and participation in pilot study'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 14', 'description': 'Participants reporting resumption of normal daily activities by Day 14', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with observed data'}, {'type': 'SECONDARY', 'title': 'Number of Patients in Each of 6 Clinical Status Categories on Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'title': 'Died', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized in ICU', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized, on supplemental oxygen', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized, not on supplemental oxygen', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Discharged, not back to normal activities', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Discharged, back to normal activities', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.73', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.90', 'ciLowerLimit': '.50', 'ciUpperLimit': '1.62', 'pValueComment': 'adjusted for baseline clinical status, region, and participation in pilot study', 'estimateComment': 'odds ratio (hIVIG vs placebo) is for being in a better category. An odds ratio \\>1 favors the hIVIG group.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline clinical status, region, and participation in pilot study'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 28', 'description': '6-category ordinal outcome corresponding to clinical status on day 28', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants with observed data'}, {'type': 'SECONDARY', 'title': 'Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'title': 'Died', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized in ICU', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized on supplemental oxygen', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalized not on supplemental oxygen', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Discharged, not back to normal activities', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Discharged, back to normal activities', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.82', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.59', 'estimateComment': 'Odds ratio (hIVIG vs placebo) is for being in a better category.', 'groupDescription': 'Multiple imputation was used to estimate the outcome for 3 participants for whom the outcome was partially unknown.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline clinical status, region, and participation in the pilot study.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7', 'description': 'Primary 6-category ordinal outcome for participants infected with Influenza A', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all participants infected with influenza A'}, {'type': 'SECONDARY', 'title': 'Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'categories': [{'title': 'Died', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Hospitalized in ICU', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Hospitalized on supplemental oxygen', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Hospitalized not on supplemental oxygen', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Discharged, not back to normal activities', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Discharged, back to normal activities', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.19', 'ciLowerLimit': '1.21', 'ciUpperLimit': '8.42', 'estimateComment': 'Odds ratio (hIVIG vs placebo) for a better outcome. An odds ratio \\> 1 favors the hIVIG group.', 'groupDescription': 'Multiple imputation was used to estimate the outcome for one participant.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for baseline clinical status, region, and participation in pilot study'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7', 'description': 'Primary 6-category ordinal outcome for subgroup of participants infected with influenza B', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'pH1N1 Titers at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '285', 'spread': '374', 'groupId': 'OG000'}, {'value': '229', 'spread': '341', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '0.84', 'ciUpperLimit': '2.7', 'estimateComment': 'Ratio of hIVIG group to placebo group. A ratio \\> 1.0 indicates higher titers for the hIVIG group.', 'groupDescription': 'HAI measurements were log-transformed to compute treatment differences and the model was adjusted for baseline titer.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'longitudinal regression with adjustment for baseline titer'}], 'paramType': 'MEAN', 'timeFrame': 'Day 7', 'description': 'pH1N1 hemagglutination inhibition assay (HAI) titers among participants infected with pH1N1 using A/Cal/2009 as reference virus', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants infected with pH1N1 with HAI titers measured at day 7'}, {'type': 'SECONDARY', 'title': 'H3N2 Titers at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '259', 'spread': '291', 'groupId': 'OG000'}, {'value': '225', 'spread': '277', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.13', 'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.8', 'estimateComment': 'Ratio of geometric means of hIVIG vs placebo. A ratio \\>1.0 indicates higher titers in the hIVIG group on day 7.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'longitudinal analysis of log-transformed titers adjust for baseline titer.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 7', 'description': 'H3N2 HAI titers among participants infected with H3N2 using A/HongKong/2014 as reference virus', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants infected with H3N2 with HAI titers measured at day 7'}, {'type': 'SECONDARY', 'title': 'Influenza B Titers at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'OG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'spread': '161', 'groupId': 'OG000'}, {'value': '84', 'spread': '83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.78', 'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.5', 'estimateComment': 'ratio of geometric mean for hIVIG vs placebo. A ratio \\> 1.0 indicates higher titers at day 7 for the hIVIG group.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'log-transformed titers adjusted for baseline titer'}], 'paramType': 'MEAN', 'timeFrame': 'Day 7', 'description': 'Flu B HAI titers among participants infected with influenza B using B/Phuket/2013 as reference virus', 'unitOfMeasure': 'titer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants infected with influenza B with HAI titers measured at day 7'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (IVIG), administered over approximately 2 hours on Day 0. Participants will also receive standard of care (SOC )treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'FG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '161'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (hIVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nIntravenous hyperimmune immunoglobulin (IVIG): Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)'}, {'id': 'BG001', 'title': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for IVIG (saline), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.\n\nPlacebo for IVIG: Administered IV as 500 mL of normal saline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '41', 'upperLimit': '68'}, {'value': '57', 'groupId': 'BG001', 'lowerLimit': '48', 'upperLimit': '68'}, {'value': '57', 'groupId': 'BG002', 'lowerLimit': '45', 'upperLimit': '68'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/ethnicity', 'categories': [{'title': 'Asian', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Black/African American', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'White/Caucasian', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'National Early Warning (NEW) score', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '4', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'description': 'National Early Warning score measured on day of randomization. The NEW score is a morbidity index based on 6 vital signs (respiratory rate, oxygen saturation, temperature, blood pressure, pulse/heart rate, level of consciousness). Each component is scored from 0 to 3 (best to worst) and the components are summed. Thus the composite score can range from 0 to 18.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'Participants in the analysis data set.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-17', 'size': 239817, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-08-21T15:26', 'hasProtocol': False}, {'date': '2016-05-31', 'size': 415552, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-21T15:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 329}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-11', 'studyFirstSubmitDate': '2014-11-06', 'resultsFirstSubmitDate': '2019-09-20', 'studyFirstSubmitQcDate': '2014-11-06', 'lastUpdatePostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-11', 'studyFirstPostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients in Each of 6 Clinical Status Categories on Day 7', 'timeFrame': 'Assessed on Day 7', 'description': 'This is the primary outcome, a 6-category ordinal outcome ranging from death (worst) to discharged from hospital with resumption of normal activities (best).'}], 'secondaryOutcomes': [{'measure': 'Number of Patients in Each of 5 Clinical Status Categories on Day 3', 'timeFrame': 'Assessed on Day 3', 'description': '5-category ordinal outcome assessed on day 3; clinical status ranges from death (worst) to discharged from the hospital (best).'}, {'measure': 'Number of Patients in Each of 6 Clinical Status Categories on Day 3', 'timeFrame': 'Measured on Day 3', 'description': '6-category ordinal outcome evaluated on Day 3; clinical status ranges from death (worst) to discharged from hospital with resumption of normal activities (best).'}, {'measure': 'Number of Patients With a Favorable Outcome on Day 7', 'timeFrame': 'Assessed on Day 7', 'description': 'Sliding dichotomy defined as non-ICU hospitalization or discharge if enrolled from ICU, and discharge if enrolled from the general ward.'}, {'measure': 'Hospital Discharge', 'timeFrame': 'Measured through Day 7', 'description': 'Number of participants alive and discharged from the hospital'}, {'measure': 'Mortality', 'timeFrame': 'Measured through day 28', 'description': 'Number of participants dying through day 28.'}, {'measure': 'Number of Patients Alive and Out of Hospital', 'timeFrame': 'Measured through Day 28', 'description': 'Number and percent alive and out of hospital on day 28'}, {'measure': 'Change in Viral Load', 'timeFrame': 'Day 3', 'description': 'Change in nasopharyngeal viral load from baseline to day 3'}, {'measure': 'Death or Re-hospitalization', 'timeFrame': 'Day 28', 'description': 'Number and percent of participants who died or were re-hospitalized after initial discharge'}, {'measure': 'Percent of Participants Developing Complications', 'timeFrame': 'Measured through Day 28', 'description': 'Number and percent of participants developing respiratory distress syndrome, acute renal failure, sepsis, pneumonia, enteritis, or bronchitis'}, {'measure': 'Number of Patients in Each of 6 Clinical Status Categories on Day 14', 'timeFrame': 'Measured on day 14', 'description': '6-category ordinal outcome measured on day 14'}, {'measure': 'Number of Patients Alive and Out of Hospital on Day 14', 'timeFrame': 'day 14', 'description': 'Number and percentage of participants alive and out of the hospital on Day 14'}, {'measure': 'Resumption of Normal Activities by Day 14', 'timeFrame': 'day 14', 'description': 'Participants reporting resumption of normal daily activities by Day 14'}, {'measure': 'Number of Patients in Each of 6 Clinical Status Categories on Day 28', 'timeFrame': 'day 28', 'description': '6-category ordinal outcome corresponding to clinical status on day 28'}, {'measure': 'Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7', 'timeFrame': 'Day 7', 'description': 'Primary 6-category ordinal outcome for participants infected with Influenza A'}, {'measure': 'Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7', 'timeFrame': 'Day 7', 'description': 'Primary 6-category ordinal outcome for subgroup of participants infected with influenza B'}, {'measure': 'pH1N1 Titers at Day 7', 'timeFrame': 'Day 7', 'description': 'pH1N1 hemagglutination inhibition assay (HAI) titers among participants infected with pH1N1 using A/Cal/2009 as reference virus'}, {'measure': 'H3N2 Titers at Day 7', 'timeFrame': 'Day 7', 'description': 'H3N2 HAI titers among participants infected with H3N2 using A/HongKong/2014 as reference virus'}, {'measure': 'Influenza B Titers at Day 7', 'timeFrame': 'Day 7', 'description': 'Flu B HAI titers among participants infected with influenza B using B/Phuket/2013 as reference virus'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Antiviral', 'IVIG', 'Hemagglutination inhibition (HAI)', 'Antibody'], 'conditions': ['Influenza A', 'Influenza B']}, 'referencesModule': {'references': [{'pmid': '37289541', 'type': 'DERIVED', 'citation': 'Vanderven HA, Wentworth DN, Han WM, Peck H, Barr IG, Davey RT Jr, Beigel JH, Dwyer DE, Jain MK, Angus B, Brandt CT, Mykietiuk A, Law MG, Neaton JD, Kent SJ; INSIGHT FLU-IVIG Study Group. Understanding the treatment benefit of hyperimmune anti-influenza intravenous immunoglobulin (Flu-IVIG) for severe human influenza. JCI Insight. 2023 Jul 24;8(14):e167464. doi: 10.1172/jci.insight.167464.'}, {'pmid': '31582358', 'type': 'DERIVED', 'citation': 'Davey RT Jr, Fernandez-Cruz E, Markowitz N, Pett S, Babiker AG, Wentworth D, Khurana S, Engen N, Gordin F, Jain MK, Kan V, Polizzotto MN, Riska P, Ruxrungtham K, Temesgen Z, Lundgren J, Beigel JH, Lane HC, Neaton JD; INSIGHT FLU-IVIG Study Group. Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial. Lancet Respir Med. 2019 Nov;7(11):951-963. doi: 10.1016/S2213-2600(19)30253-X. Epub 2019 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is usually mild, but can cause serious illness or death. The purpose of this study is to test the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune immunoglobulin or IVIG) in people who are hospitalized for severe flu.', 'detailedDescription': 'Influenza is responsible for thousands of hospitalizations and deaths each year in the United States and worldwide. One possible new treatment for the flu involves the use of IVIG, a blood product containing antibodies from people who have recovered from the flu or who have had a flu shot. The purpose of this study is to evaluate whether IVIG can reduce the severity and duration of flu in people who are hospitalized with the flu.\n\nThe study will enroll participants 18 years and older who are hospitalized with the flu. The study will enroll participants over one or more flu seasons. Regardless of the date of enrollment, each participant will be in the study for about 28 days.\n\nAt study entry (Day 0), participants will be randomly assigned to one of two groups (Arms A and B). Participants in both groups will receive standard of care (SOC) treatment for the flu, but those in Arm A will also receive one dose of IVIG and those in Arm B will receive a placebo for IVIG. Both IVIG and placebo will be given intravenously over at least 2 hours.\n\nOn Day 0, before receiving IVIG or placebo, participants will undergo a symptoms assessment, blood collection, and a nasopharyngeal (NP) swab to collect a sample of secretions from the nose and throat.\n\nAdditional study visits will occur on Days 1, 2, 3, 7, 14, and 28. Depending on the visit, participants may take part in the same study procedures that took place on Day 0. On Days 2, 14, and 28, visits for participants who are no longer hospitalized may be conducted over the phone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Locally determined positive influenza test (by polymerase chain reaction \\[PCR\\] or other nucleic acid test, or by rapid antigen \\[Ag\\]) from a specimen obtained within 2 days prior to randomization\n* Onset of illness no more than 7 days before randomization, defined as when the participant first experienced at least one respiratory symptom or fever\n* Hospitalized (or in observation unit) for influenza, with anticipated hospitalization for more than 24 hours. Criteria for hospitalization will be up to the individual treating clinician.\n* For women of child-bearing potential: willingness to abstain from sexual intercourse or use at least one form of hormonal or barrier contraception through Day 28 of the study\n* Willingness to have blood and respiratory samples obtained and stored\n* NEW score greater than or equal to 2 at screening (see the protocol for more information on this criterion)\n\nExclusion Criteria:\n\n* Women who are pregnant or breast-feeding\n* Strong clinical evidence (in the judgment of the site investigator) that the etiology of illness is primarily bacterial in origin\n* Prior treatment with any investigational drug therapy within 30 days prior to screening\n* History of allergic reaction to blood or plasma products (as judged by the site investigator)\n* Known immunoglobulin A (IgA) deficiency\n* A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the participant at a substantially increased risk of thrombosis (e.g., cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically significant monoclonal gammopathy)\n* Presence of any pre-existing illness that, in the opinion of the site investigator, would place the participant at an unreasonably increased risk through participation in this study\n* Participants who, in the judgment of the site investigator, will be unlikely to comply with the requirements of this protocol\n* Medical conditions for which receipt of a 500 mL volume of intravenous fluid may be dangerous to the participant (e.g., decompensated congestive heart failure)\n* Receiving extracorporeal membrane oxygenation (ECMO)\n* Suspicion that infection is due to an influenza strain or subtype other than A(H1N1)pdm09, H3N2, or influenza B (e.g., H5N1, H7N9)'}, 'identificationModule': {'nctId': 'NCT02287467', 'briefTitle': 'Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)', 'orgStudyIdInfo': {'id': 'INSIGHT 006: FLU-IVIG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: hIVIG', 'description': 'Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (hIVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.', 'interventionNames': ['Biological: Intravenous hyperimmune immunoglobulin (IVIG)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm B: Placebo', 'description': 'Participants will receive a single infusion of placebo for hIVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu.', 'interventionNames': ['Biological: Placebo for IVIG']}], 'interventions': [{'name': 'Intravenous hyperimmune immunoglobulin (IVIG)', 'type': 'BIOLOGICAL', 'description': 'Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)', 'armGroupLabels': ['Arm A: hIVIG']}, {'name': 'Placebo for IVIG', 'type': 'BIOLOGICAL', 'description': 'Administered IV as 500 mL of normal saline', 'armGroupLabels': ['Arm B: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Antiviral Research Center (A VRC)', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Public Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis VA Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper University Hospital', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Cornell CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'OHIO State University (OSU) Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45409', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Miami Valley Hospital', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'city': 'Sydney', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Leeds', 'country': 'United Kingdom', 'facility': "St James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Churchill Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Richard T. Davey, Jr., MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, {'name': 'Eduardo Fernández-Cruz, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital General Universitario Gregorio Marañón'}, {'name': 'Norman P. Markowitz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Henry Ford Hospital'}, {'name': 'Sarah L. Pett, MD, MBBS, DTM, MRCP (UK)', 'role': 'STUDY_CHAIR', 'affiliation': 'University College, London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'University of Minnesota', 'class': 'OTHER'}, {'name': 'International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}