Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-25 @ 2:35 AM
Study NCT ID:
NCT05507567
Status:
COMPLETED
Last Update Posted:
2024-10-28
First Post:
2022-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza Via a Human Viral Challenge Model
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'douglas.thomson@pneumagen.com', 'phone': '+44 7748357352', 'title': 'CEO', 'organization': 'Pneumagen Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the intake of the first dose of IMP on Day -3 to Day 28', 'description': 'Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28.\n\nSolicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.', 'eventGroups': [{'id': 'EG000', 'title': 'Neumifil Multiple Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge\n\nNeumifil: Liquid for intranasal spray administration', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 30, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Neumifil Single Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as a single daily dose on Day -3 and blinded by placebo administered as two single daily doses. All administrations completed prior to viral challenge\n\nNeumifil: Liquid for intranasal spray administration\n\nPlacebo: Liquid for intranasal spray administration', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 25, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Intranasal spray administered as 3 single daily doses prior to viral challenge\n\nPlacebo: Liquid for intranasal spray administration', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 34, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Covid-19', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nasopharyngitis', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Otitis externa', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tonsilitis', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Electrocardiogram T wave abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Electrocardiogram T wave biphasic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Forced expiratory volume decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hepatic enzyme abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Myalgia', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthralgia', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Back pain', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pain in extremity', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Axillary pain', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fatigue', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Peripheral swelling', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Asthenopia', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blepharitis', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Toothache', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Contusion', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Thermal burn', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Anosmia', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oropharyngeal pain', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Sinus pain', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rash papular', 'notes': 'Indicates events were unsolicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bleeding from the nose', 'notes': 'Indicates events were solicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Diary card'}, {'term': 'Burning sensation or sensation of heat/hotness in the nose', 'notes': 'Indicates events were solicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Diary card'}, {'term': 'General irritation in the nose', 'notes': 'Indicates events were solicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 40, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 26, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 32, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Diary card'}, {'term': 'Marked change in sense of smell or taste', 'notes': 'Indicates events were solicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Diary card'}, {'term': 'Pain or stinging in the nose', 'notes': 'Indicates events were solicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Diary card'}, {'term': 'Sensation of needing to blow your nose', 'notes': 'Indicates events were solicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 70, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 30, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 28, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Diary card'}, {'term': 'Sneezing', 'notes': 'Indicates events were solicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 40, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 30, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Diary card'}, {'term': 'Unpleasant taste', 'notes': 'Indicates events were solicited', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 27, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 22, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Diary card'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Symptomatic Influenza Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Neumifil Multiple Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge'}, {'id': 'OG001', 'title': 'Neumifil Single Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as a single daily dose on Day -3 prior to viral challenge'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo intranasal spray administered as 3 single daily doses prior to viral challenge'}, {'id': 'OG003', 'title': 'Pooled Neumifil Groups', 'description': 'Pooled groups:Neumifil intranasal spray administered prior to viral challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0331', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'A priori primary analysis group', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 8', 'description': 'Number of subjects with quantifiable viral shedding on 2 consecutive days AND with any symptom score of grade 2 or greater at a single time point.\n\nViral shedding was measured by RT-qPCR. Eleven symptoms were assessed by questionnaire and were graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population (participants who received all doses, challenge virus and completed quarantine up to Day 8)'}, {'type': 'PRIMARY', 'title': 'Severity of Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Neumifil Multiple Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge'}, {'id': 'OG001', 'title': 'Neumifil Single Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as a single daily dose on Day -3 prior to viral challenge'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo intranasal spray administered as 3 single daily doses prior to viral challenge'}, {'id': 'OG003', 'title': 'Pooled Neumifil Groups', 'description': 'Pooled groups:Neumifil intranasal spray administered prior to viral challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '16.0'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '12.0'}, {'value': '3.00', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '17.0'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '16.0'}]}]}], 'analyses': [{'pValue': '0.1427', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'Hodges-Lehmann (H-L) estimation', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'statisticalComment': '1-sided Wilcoxon rank-sum'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to Day 8', 'description': 'Change in Peak Total Symptom Score (TSS) as measured by graded symptom scoring system collected 3 times daily; symptom questionnaire was graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).Lower score means better outcome. The range was 0 to 33.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve (AUC) Over Time of Total Symptom Score (TSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Neumifil Multiple Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge'}, {'id': 'OG001', 'title': 'Neumifil Single Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as a single daily dose on Day -3 prior to viral challenge'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo intranasal spray administered as 3 single daily doses prior to viral challenge'}, {'id': 'OG003', 'title': 'Pooled Neumifil Groups', 'description': 'Pooled groups:Neumifil intranasal spray administered prior to viral challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '4.05', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '47.7'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '25.8'}, {'value': '3.73', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '50.0'}, {'value': '2.44', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '47.7'}]}]}], 'analyses': [{'pValue': '0.1307', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'H-L estimation', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'statisticalComment': '1-sided Wilcoxon rank-sum'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to Day 8', 'description': 'Participants completed a self-assessment symptom score 3 times daily, graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).Lower score means better outcome. Range 0 to 33', 'unitOfMeasure': '(Units on a scale)*day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population'}, {'type': 'SECONDARY', 'title': 'Viral Shedding Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Neumifil Multiple Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge'}, {'id': 'OG001', 'title': 'Neumifil Single Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as a single daily dose on Day -3 prior to viral challenge'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo intranasal spray administered as 3 single daily doses prior to viral challenge'}, {'id': 'OG003', 'title': 'Pooled Neumifil Groups', 'description': 'Pooled groups:Neumifil intranasal spray administered prior to viral challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '9.96', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '40.2'}, {'value': '8.60', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '39.0'}, {'value': '17.24', 'groupId': 'OG002', 'lowerLimit': '6.3', 'upperLimit': '44.8'}, {'value': '9.39', 'groupId': 'OG003', 'lowerLimit': '6.3', 'upperLimit': '40.2'}]}]}], 'analyses': [{'pValue': '0.0382', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'H-L estimation', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'statisticalComment': '1-sided Wilcoxon rank-sum'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (pm) to Day 8 (am)', 'description': 'Measurement of influenza viral load (VL) area under the curve (VL-AUC) of quantifiable measurements by RT-qPCR in nasal samples.\n\nThe AUC is expressed as the log to the base 10 copies in a mL of nasal fluid multiplied by the time in days \\[(log10 copies/mL)\\*day\\]. The higher the viral load AUC, by PCR, the worse the outcome.', 'unitOfMeasure': '(log10 copies/mL)*day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}, {'type': 'SECONDARY', 'title': 'Viral Shedding Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Neumifil Multiple Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge'}, {'id': 'OG001', 'title': 'Neumifil Single Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as a single daily dose on Day -3 prior to viral challenge'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo intranasal spray administered as 3 single daily doses prior to viral challenge'}, {'id': 'OG003', 'title': 'Pooled Neumifil Groups', 'description': 'Pooled groups:Neumifil intranasal spray administered prior to viral challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '3.29', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '15.7'}, {'value': '3.30', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '18.0'}, {'value': '4.79', 'groupId': 'OG002', 'lowerLimit': '3.2', 'upperLimit': '17.9'}, {'value': '3.30', 'groupId': 'OG003', 'lowerLimit': '3.2', 'upperLimit': '18.0'}]}]}], 'analyses': [{'pValue': '0.0110', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'H-L estimation', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'statisticalComment': '1-sided Wilcoxon rank-sum'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (pm) to Day 8 (am)', 'description': 'Measurement of influenza viral load (VL) in nasal samples over time (VL-AUC) measured by viral culture. Nasal secretions were cultured and the Tissue Culture Infectious Dose (TCID50) calculated. The AUC of log to the base 10 of the TCID50 in each mL of nasal secretions, multiplied by the time in days \\[(log10 TCID50/mL)\\*day\\] was calculated. The higher the viral load AUC by culture, the worse the outcome.', 'unitOfMeasure': '(log10 TCID50/mL)*day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population (one participant in the placebo group had a missing value)'}, {'type': 'SECONDARY', 'title': 'Weight of Nasal Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Neumifil Multiple Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge'}, {'id': 'OG001', 'title': 'Neumifil Single Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as a single daily dose on Day -3 prior to viral challenge'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo intranasal spray administered as 3 single daily doses prior to viral challenge'}, {'id': 'OG003', 'title': 'Pooled Neumifil Groups', 'description': 'Pooled groups:Neumifil intranasal spray administered prior to viral challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '5.24', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '83.2'}, {'value': '0.26', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '54.2'}, {'value': '2.74', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '43.7'}, {'value': '0.97', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '83.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (am) to Day 8 (am)', 'description': 'Measurement of total weight of mucus produced by participants. The total weight of used tissues was measured to assess the weight of mucus produced. The greater the weight of the tissues the more mucus produced and the worse the outcome.', 'unitOfMeasure': 'grams', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population (Data not available for all participants)'}, {'type': 'SECONDARY', 'title': 'Nasal Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Neumifil Multiple Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge'}, {'id': 'OG001', 'title': 'Neumifil Single Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as a single daily dose on Day -3 prior to viral challenge'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo intranasal spray administered as 3 single daily doses prior to viral challenge'}, {'id': 'OG003', 'title': 'Pooled Neumifil Groups', 'description': 'Pooled groups:Neumifil intranasal spray administered prior to viral challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '14.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '144.0'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '88.0'}, {'value': '7.00', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '52.0'}, {'value': '5.5', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '144.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (am) to Day 8 (am)', 'description': 'The number of tissues used by participants were counted. The greater the number of tissues used the worse the outcome.', 'unitOfMeasure': 'sum of number of tissues', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population (Data not available for all participants)'}, {'type': 'SECONDARY', 'title': 'Adverse Events, Solicited', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Neumifil Multiple Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge\n\nNeumifil: Liquid for intranasal spray administration'}, {'id': 'OG001', 'title': 'Neumifil Single Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as a single dose on Day -3 and blinded by placebo administered as two single daily doses. All administrations completed prior to viral challenge\n\nNeumifil: Liquid for intranasal spray administration\n\nPlacebo: Liquid for intranasal spray administration'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Intranasal spray administered as 3 single daily doses prior to viral challenge\n\nPlacebo: Liquid for intranasal spray administration'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From intake of first dose of IMP (Day -3) up to 12 hours post the last IMP dose (Day -1)', 'description': 'Number of participants reporting a solicited adverse event during the treatment period of IMP', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Adverse Events, Unsolicited', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Neumifil Multiple Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge\n\nNeumifil: Liquid for intranasal spray administration'}, {'id': 'OG001', 'title': 'Neumifil Single Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as a single dose on Day -3 and blinded by placebo administered as two single daily doses. All administrations completed prior to viral challenge\n\nNeumifil: Liquid for intranasal spray administration\n\nPlacebo: Liquid for intranasal spray administration'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Intranasal spray administered as 3 single daily doses prior to viral challenge\n\nPlacebo: Liquid for intranasal spray administration'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From intake of first dose of IMP on Day -3 to Day 28', 'description': 'Number of participants reporting treatment emergent adverse events, unsolicited', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Neumifil Multiple Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge\n\nNeumifil: Liquid for intranasal spray administration'}, {'id': 'FG001', 'title': 'Neumifil Single Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as a single dose on Day -3 and blinded by placebo administered as two single daily doses. All administrations completed prior to viral challenge\n\nNeumifil: Liquid for intranasal spray administration\n\nPlacebo: Liquid for intranasal spray administration'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Intranasal spray administered as 3 single daily doses prior to viral challenge\n\nPlacebo: Liquid for intranasal spray administration'}], 'periods': [{'title': 'Randomised and Received Challenge Virus', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Did not complete quarantine', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'From Challenge Virus to End of Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Following screening (Day -93 to Day -5), this study was conducted with an inpatient phase (Day -4 to Day 8) and an outpatient follow-up on Day 28 (plus or minus 3 days). During the inpatient quarantine phase, participants received Neumifil or placebo according to the randomisation on Day -3, Day -2 and Day -1, and then received Influenza Challenge Virus on Day 0. The study was conducted at one site in the UK between 12 August 2022 and 03 May 2023.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Neumifil Multiple Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge\n\nNeumifil: Liquid for intranasal spray administration'}, {'id': 'BG001', 'title': 'Neumifil Single Dose Prophylactic Treatment', 'description': 'Neumifil intranasal spray administered as a single dose on Day -3 and blinded by placebo administered as two single daily doses. All administrations completed prior to viral challenge\n\nNeumifil: Liquid for intranasal spray administration\n\nPlacebo: Liquid for intranasal spray administration'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Intranasal spray administered as 3 single daily doses prior to viral challenge\n\nPlacebo: Liquid for intranasal spray administration'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.22', 'spread': '6.79', 'groupId': 'BG000'}, {'value': '30.32', 'spread': '7.06', 'groupId': 'BG001'}, {'value': '31.05', 'spread': '8.82', 'groupId': 'BG002'}, {'value': '30.88', 'spread': '7.67', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-12', 'size': 3967438, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-30T06:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, Double-blind, Placebo-controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-24', 'studyFirstSubmitDate': '2022-08-17', 'resultsFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2022-08-17', 'lastUpdatePostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-24', 'studyFirstPostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Symptomatic Influenza Infection', 'timeFrame': 'Day 1 to Day 8', 'description': 'Number of subjects with quantifiable viral shedding on 2 consecutive days AND with any symptom score of grade 2 or greater at a single time point.\n\nViral shedding was measured by RT-qPCR. Eleven symptoms were assessed by questionnaire and were graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).'}, {'measure': 'Severity of Symptoms', 'timeFrame': 'Day 1 to Day 8', 'description': 'Change in Peak Total Symptom Score (TSS) as measured by graded symptom scoring system collected 3 times daily; symptom questionnaire was graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).Lower score means better outcome. The range was 0 to 33.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve (AUC) Over Time of Total Symptom Score (TSS)', 'timeFrame': 'Day 1 to Day 8', 'description': 'Participants completed a self-assessment symptom score 3 times daily, graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).Lower score means better outcome. Range 0 to 33'}, {'measure': 'Viral Shedding Over Time', 'timeFrame': 'Day 1 (pm) to Day 8 (am)', 'description': 'Measurement of influenza viral load (VL) area under the curve (VL-AUC) of quantifiable measurements by RT-qPCR in nasal samples.\n\nThe AUC is expressed as the log to the base 10 copies in a mL of nasal fluid multiplied by the time in days \\[(log10 copies/mL)\\*day\\]. The higher the viral load AUC, by PCR, the worse the outcome.'}, {'measure': 'Viral Shedding Over Time', 'timeFrame': 'Day 1 (pm) to Day 8 (am)', 'description': 'Measurement of influenza viral load (VL) in nasal samples over time (VL-AUC) measured by viral culture. Nasal secretions were cultured and the Tissue Culture Infectious Dose (TCID50) calculated. The AUC of log to the base 10 of the TCID50 in each mL of nasal secretions, multiplied by the time in days \\[(log10 TCID50/mL)\\*day\\] was calculated. The higher the viral load AUC by culture, the worse the outcome.'}, {'measure': 'Weight of Nasal Discharge', 'timeFrame': 'Day 1 (am) to Day 8 (am)', 'description': 'Measurement of total weight of mucus produced by participants. The total weight of used tissues was measured to assess the weight of mucus produced. The greater the weight of the tissues the more mucus produced and the worse the outcome.'}, {'measure': 'Nasal Discharge', 'timeFrame': 'Day 1 (am) to Day 8 (am)', 'description': 'The number of tissues used by participants were counted. The greater the number of tissues used the worse the outcome.'}, {'measure': 'Adverse Events, Solicited', 'timeFrame': 'From intake of first dose of IMP (Day -3) up to 12 hours post the last IMP dose (Day -1)', 'description': 'Number of participants reporting a solicited adverse event during the treatment period of IMP'}, {'measure': 'Adverse Events, Unsolicited', 'timeFrame': 'From intake of first dose of IMP on Day -3 to Day 28', 'description': 'Number of participants reporting treatment emergent adverse events, unsolicited'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Influenza', 'Human Challenge', 'Prophylaxis'], 'conditions': ['Influenza Viral Infections']}, 'referencesModule': {'references': [{'pmid': '40593264', 'type': 'DERIVED', 'citation': 'Kitson G, Byford M, Cass L, Howat D, Kohn B, Bisquera A, Catchpole A, Noulin N, Thomson D. A Phase II, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of HEX17, a Novel Broad-Spectrum Antiviral Drug, in a Controlled Human Infection Model of Influenza Challenge. Infect Dis Ther. 2025 Aug;14(8):1697-1714. doi: 10.1007/s40121-025-01179-2. Epub 2025 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'Study to assess the efficacy and safety of a multiple dose regimen and a single dose regimen of intranasal Neumifil, administered prior to challenge with Influenza virus in healthy adult participants', 'detailedDescription': 'This is a single-centre, randomized, double-blind, placebo-controlled study in healthy adult participants to assess the pre-exposure prophylactic antiviral activity of Neumifil via a human viral challenge model.\n\nParticipants will enter the quarantine unit on Day -4.\n\nParticipants will be randomized to receive either active (single dose), active (multiple dose) or placebo in a 3:3:4 ratio followed by influenza viral challenge on Day 0.\n\nParticipants will leave the unit on Day 8, provided that no virus is detected by a qualitative virus antigen test and the participant has no clinically significant symptoms. A final follow-up will be performed on Day 28.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent signed and dated by the participant and the investigator obtained before any assessment is performed.\n2. Adult male or female aged between 18 and 55 years old, inclusive, on the day prior to signing the consent form.\n3. A total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2.\n4. In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), ECG, and routine laboratory tests as determined by the investigator.\n5. Participants will have a documented medical history either prior to entering the study or following medical history review with the study physician at screening.\n6. Agree to use highly effective contraception\n7. Serosuitable for the challenge virus\n\nExclusion Criteria:\n\n1. History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (URT, LRT) infection within 4 weeks prior to the first study visit.\n2. Any history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological (including immunosuppression), metabolic, urological, renal, neurological, or psychiatric disease and/or other major disease that, in the opinion of the investigator, may interfere with a participant completing the study and necessary investigations. Includes a history of depression or anxiety.\n3. Any participants who have smoked ≥ 10 pack years at any time.\n4. Females who are pregnant or breastfeeding\n5. Any history of anaphylaxis or history of severe allergic reactions to any foods, drugs, insect bites or stings or any known allergy to tetracycline antibiotics.\n6. Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.\n7. a) Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and, in particular, any of the nasal assessments or viral challenge b) Any evidence of nasal inflammation or nasal polyps within the last month c) Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first study visit and/or history of being hospitalised due to epistaxis on any previous occasion.\n\n d) Any nasal or sinus surgery within 3 months of the first study visit. Prior or Concomitant Medications and Assessments\n8. a) Evidence of vaccinations within the 4 weeks prior to the planned date of first dosing with IMP.\n\n b) Intention to receive any vaccination(s) before the last day of follow-up (with the exception of vaccinations recommended for COVID19 as defined by Medicines and Healthcare Regulatory Agency (MHRA)/government vaccination guidelines). No travel restrictions apply after the Day 28 (±3 days) follow-up visit.\n\n c) Receipt of influenza vaccine (or another IMP relating to treatment of influenza) in the last 6 months prior to the planned date of viral challenge OR a diagnosis of influenza or influenza-like illness confirmed by a physician within the last 2 months prior to screening.\n9. Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 3 months prior to the planned date of first dosing with IMP or planned during the 3 months after the final follow-up visit.\n10. a) Receipt of any investigational drug within 3 months (or 5 half-lives of the IMP used in the other study, whichever is greater), prior to the planned date of first dosing with IMP.\n\n b) Receipt of 3 or more investigational drugs within the previous 12 months prior to the planned date of first dosing with IMP.\n\n c) Prior inoculation with a virus from the same virus-family as the challenge virus.\n\n d) Prior participation in another human viral challenge study with a respiratory virus in the preceding 3 months.\n11. Use or anticipated use during the conduct of the study of concomitant medications\n12. Confirmed positive test for drugs of misuse and cotinine on first study visit\n\n13 Recent history or presence of alcohol addiction, or excessive use of alcohol\n\n14\\. A FEV1 \\<80%, a FVC \\<80% predicted, or an FEV1/FVC ratio \\<0.7. 15. Positive HIV, hepatitis B virus, or hepatitis C virus test.'}, 'identificationModule': {'nctId': 'NCT05507567', 'briefTitle': 'Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza Via a Human Viral Challenge Model', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pneumagen Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Phase 2a Study To Assess the Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza, Via a Human Viral Challenge Model in Healthy Adult Participants', 'orgStudyIdInfo': {'id': 'PNG-NMF-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neumifil multiple dose prophylactic treatment', 'description': 'Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge', 'interventionNames': ['Drug: Neumifil']}, {'type': 'EXPERIMENTAL', 'label': 'Neumifil single dose prophylactic treatment', 'description': 'Neumifil intranasal spray administered as a single dose and blinded by placebo administered as two single daily doses. All administrations completed prior to viral challenge', 'interventionNames': ['Drug: Neumifil', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intranasal spray administered as 3 single daily doses prior to viral challenge', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Neumifil', 'type': 'DRUG', 'description': 'Liquid for intranasal spray administration', 'armGroupLabels': ['Neumifil multiple dose prophylactic treatment', 'Neumifil single dose prophylactic treatment']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Liquid for intranasal spray administration', 'armGroupLabels': ['Neumifil single dose prophylactic treatment', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 2AX', 'city': 'London', 'country': 'United Kingdom', 'facility': 'hVIVO Services Limited', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Geoff Kitson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'gkitson@propharmapartners.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pneumagen Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}