Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-27 @ 2:14 AM
Study NCT ID:
NCT04631666
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2020-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Infusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000715848', 'term': 'BI 767551'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'florian.klein@uk-koeln.de', 'phone': '49221478', 'title': 'Prof. Florian Klein', 'phoneExt': '85800', 'organization': 'Institute of Virology'}, 'certainAgreement': {'otherDetails': 'Publications by PIs are to be submitted to the sponsor for review at least 30 days prior to planned disclosure. Modifications suggested by the sponsor should be considered unless they affect the scientific character or neutrality of the publication. A maximum embargo period of 90 days is applicable only if disclosure would affect (potential) intellectual property rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)', 'description': 'Participants were queried for Adverse Events at all study visits', 'eventGroups': [{'id': 'EG000', 'title': '1A: Healthy, 2.5 mg/kg', 'description': 'SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 2.5 mg/kg\n\nDZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '1B: Healthy, 10 mg/kg', 'description': 'SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 10 mg/kg\n\nDZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '1C: Healthy, 40 mg/kg', 'description': 'SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 40 mg/kg\n\nDZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '1D: Healthy, 80 mg/kg', 'description': 'SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose higher than 40 mg/kg\n\nDZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '2C: Infected, 40 mg/kg', 'description': 'SARS-CoV-2-infected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 40 mg/kg\n\nDZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '2D: Infected, 40 mg/kg', 'description': 'SARS-CoV-2-infected volunteers randomized to receive an intravenous infusion of DZIF-10c at a dose of 40 mg/kg (blinded)\n\nDZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 18, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '2D: Infected, Placebo', 'description': 'SARS-CoV-2-infected volunteers randomized to receive an intravenous infusion of placebo (blinded)\n\nPlacebo: Sterile normal saline', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 10, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyposmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypogeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Parosmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ageusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 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{'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 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[{'type': 'PRIMARY', 'title': 'Proportion of Patients With Any AE Within 7 d of Study Drug Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '1A: Healthy, 2.5 mg/kg', 'description': 'Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion'}, {'id': 'OG001', 'title': '1B: Healthy, 10 mg/kg', 'description': 'Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion'}, {'id': 'OG002', 'title': '1C: Healthy, 40 mg/kg', 'description': 'Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion'}, {'id': 'OG003', 'title': '1D: Healthy, 80 mg/kg', 'description': 'Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion'}, {'id': 'OG004', 'title': '2C: Infected, 40 mg/kg', 'description': 'Open label, 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'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '1A: Healthy, 2.5 mg/kg', 'description': 'Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion'}, {'id': 'OG001', 'title': '1B: Healthy, 10 mg/kg', 'description': 'Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion'}, {'id': 'OG002', 'title': '1C: Healthy, 40 mg/kg', 'description': 'Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion'}, {'id': 'OG003', 'title': '1D: Healthy, 80 mg/kg', 'description': 'Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion'}, {'id': 'OG004', 'title': '2C: Infected, 40 mg/kg', 'description': 'Open label, SARS-CoV-2-infected, DZIF-10c i.v. infusion'}, {'id': 'OG005', 'title': '2D: Infected, 40 mg/kg', 'description': 'Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '12800', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '8460', 'spread': '18', 'groupId': 'OG001'}, {'value': '8160', 'spread': '45.7', 'groupId': 'OG002'}, {'value': '10300', 'spread': '21.8', 'groupId': 'OG003'}, {'value': '6790', 'spread': '29.6', 'groupId': 'OG004'}, {'value': '10700', 'spread': '19.7', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post dose', 'unitOfMeasure': 'ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anti-Drug Antibody Development', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '1A: Healthy, 2.5 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'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0, 14, 28, 56, 90 days post dose', 'description': 'Individuals developing anti-drug antibodies', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anti-Drug Antibody Peak Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '2C: Infected, 40 mg/kg', 'description': 'Open label, SARS-CoV-2-infected, DZIF-10c i.v. infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '960', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0, 14, 28, 56, 90 days post dose', 'description': 'Magnitude of the development of anti-drug antibodies targeting DZIF-10c in individuals developing such antibodies (peak serum titer)', 'unitOfMeasure': 'reciprocal serum titer', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time-weighted SARS-CoV-2 Viral Load Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2D: Infected, 40 mg/kg', 'description': 'Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion'}, {'id': 'OG001', 'title': '2D: Infected, Placebo', 'description': 'Double-blind and randomized, SARS-CoV-2-infected, placebo i.v. infusion'}], 'classes': [{'title': 'Over 7 days', 'categories': [{'measurements': [{'value': '-2.035', 'spread': '0.146', 'groupId': 'OG000'}, {'value': '-1.449', 'spread': '0.217', 'groupId': 'OG001'}]}]}, {'title': 'Over 14 days', 'categories': [{'measurements': [{'value': '-3.273', 'spread': '0.126', 'groupId': 'OG000'}, {'value': '-2.668', 'spread': '0.188', 'groupId': 'OG001'}]}]}, {'title': 'Over 28 days', 'categories': [{'measurements': [{'value': '-3.938', 'spread': '0.096', 'groupId': 'OG000'}, {'value': '-3.576', 'spread': '0.143', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 1, 3, 7, 14, 28 days post dose', 'description': 'Time-weighted change of SARS-CoV-2 viral load from baseline in nasopharyngeal swab samples as determined by the SARS-CoV-2 E gene; based on a parametric analysis of covariance model with corresponding baseline viral load, antibody status at baseline, and treatment; determined as the adjusted mean area over the curve (AOC) for samples collected at baseline and 1, 3, 7, 14, 28 days post dose', 'unitOfMeasure': 'log10 cp/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MMRM SARS-CoV-2 Viral Load Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2D: Infected, 40 mg/kg', 'description': 'Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion'}, {'id': 'OG001', 'title': '2D: Infected, Placebo', 'description': 'Double-blind and randomized, SARS-CoV-2-infected, placebo i.v. infusion'}], 'classes': [{'title': 'Over 7 days', 'categories': [{'measurements': [{'value': '-4.3', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Over 14 days', 'categories': [{'measurements': [{'value': '-4.5', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Over 28 days', 'categories': [{'measurements': [{'value': '-4.7', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 1, 3, 7, 14, 28 days post dose', 'description': 'Change of SARS-CoV-2 viral load from baseline in nasopharyngeal swab samples as determined by the SARS-CoV-2 E gene; based on Mixed Model for Repeated Measures (MMRM) with fixed effects for antibody status at BL, LOG10 (viral load) at BL and interaction with visit, treatment-by-visit interaction, and random effect for patient; samples collected at baseline and 1, 3, 7, 14, 28 days post dose', 'unitOfMeasure': 'Adjusted log10 cp/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1A: Healthy, 2.5 mg/kg', 'description': 'Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion'}, {'id': 'FG001', 'title': '1B: Healthy, 10 mg/kg', 'description': 'Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion'}, {'id': 'FG002', 'title': '1C: Healthy, 40 mg/kg', 'description': 'Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion'}, {'id': 'FG003', 'title': '1D: Healthy, 80 mg/kg', 'description': 'Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion'}, {'id': 'FG004', 'title': '2C: Infected, 40 mg/kg', 'description': 'Open label, SARS-CoV-2-infected, DZIF-10c i.v. infusion'}, {'id': 'FG005', 'title': '2D: Infected, 40 mg/kg', 'description': 'Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion'}, {'id': 'FG006', 'title': '2D: Infected, Placebo', 'description': 'Double-blind and randomized, SARS-CoV-2-infected, placebo i.v. infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '26'}, {'groupId': 'FG006', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '26'}, {'groupId': 'FG006', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '57', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': '1A: Healthy, 2.5 mg/kg', 'description': 'Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion'}, {'id': 'BG001', 'title': '1B: Healthy, 10 mg/kg', 'description': 'Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion'}, {'id': 'BG002', 'title': '1C: Healthy, 40 mg/kg', 'description': 'Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion'}, {'id': 'BG003', 'title': '1D: Healthy, 80 mg/kg', 'description': 'Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion'}, {'id': 'BG004', 'title': '2C: Infected, 40 mg/kg', 'description': 'Open label, SARS-CoV-2-infected, DZIF-10c i.v. infusion'}, {'id': 'BG005', 'title': '2D: Infected, 40 mg/kg', 'description': 'Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion'}, {'id': 'BG006', 'title': '2D: Infected, Placebo', 'description': 'Double-blind and randomized, SARS-CoV-2-infected, placebo i.v. infusion'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '57', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '34'}, {'value': '28', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '39'}, {'value': '28', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '28'}, {'value': '26.5', 'groupId': 'BG003', 'lowerLimit': '26', 'upperLimit': '28'}, {'value': '43', 'groupId': 'BG004', 'lowerLimit': '41', 'upperLimit': '48'}, {'value': '40', 'groupId': 'BG005', 'lowerLimit': '30', 'upperLimit': '52'}, {'value': '32', 'groupId': 'BG006', 'lowerLimit': '25', 'upperLimit': '47'}, {'value': '32', 'groupId': 'BG007', 'lowerLimit': '27.5', 'upperLimit': '42.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '57', 'groupId': 'BG007'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '27', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '30', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '57', 'groupId': 'BG007'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '57', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-07', 'size': 1918485, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-06T04:42', 'hasProtocol': True}, {'date': '2021-04-20', 'size': 1266207, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-06T04:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This study consists of an open-label dose escalation phase in healthy volunteers (Groups 1A-1C) and an additional open-label lead-in phase in SARS-CoV-2-infected individuals (Group 2C).\n\nAfter completion of the dose escalation phase, SARS-CoV-2-infected individuals will be enrolled into a randomized placebo-controlled expansion cohort (Group 2D).\n\nAn additional higher dose cohort may be included for healthy volunteers (Group 1D).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-11', 'studyFirstSubmitDate': '2020-11-05', 'resultsFirstSubmitDate': '2022-12-06', 'studyFirstSubmitQcDate': '2020-11-14', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-11', 'studyFirstPostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients With Any AE Within 7 d of Study Drug Infusion', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'DZIF-10c Elimination Half Life', 'timeFrame': '0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post dose', 'description': 'DZIF-10c serum elimination half-life'}, {'measure': 'DZIF-10c Peak Serum Concentration', 'timeFrame': '0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post dose'}, {'measure': 'DZIF-10c Area Under the Curve', 'timeFrame': '0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post dose', 'description': 'Area under the curve based on serum antibody levels'}, {'measure': 'DZIF-10c Clearance', 'timeFrame': '0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post dose'}, {'measure': 'DZIF-10c Volume of Distribution Vz', 'timeFrame': '0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post dose'}, {'measure': 'Anti-Drug Antibody Development', 'timeFrame': '0, 14, 28, 56, 90 days post dose', 'description': 'Individuals developing anti-drug antibodies'}, {'measure': 'Anti-Drug Antibody Peak Titer', 'timeFrame': '0, 14, 28, 56, 90 days post dose', 'description': 'Magnitude of the development of anti-drug antibodies targeting DZIF-10c in individuals developing such antibodies (peak serum titer)'}, {'measure': 'Time-weighted SARS-CoV-2 Viral Load Change From Baseline', 'timeFrame': '0, 1, 3, 7, 14, 28 days post dose', 'description': 'Time-weighted change of SARS-CoV-2 viral load from baseline in nasopharyngeal swab samples as determined by the SARS-CoV-2 E gene; based on a parametric analysis of covariance model with corresponding baseline viral load, antibody status at baseline, and treatment; determined as the adjusted mean area over the curve (AOC) for samples collected at baseline and 1, 3, 7, 14, 28 days post dose'}, {'measure': 'MMRM SARS-CoV-2 Viral Load Change From Baseline', 'timeFrame': '0, 1, 3, 7, 14, 28 days post dose', 'description': 'Change of SARS-CoV-2 viral load from baseline in nasopharyngeal swab samples as determined by the SARS-CoV-2 E gene; based on Mixed Model for Repeated Measures (MMRM) with fixed effects for antibody status at BL, LOG10 (viral load) at BL and interaction with visit, treatment-by-visit interaction, and random effect for patient; samples collected at baseline and 1, 3, 7, 14, 28 days post dose'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'Covid-19', 'Infusion', 'Monoclonal Antibody'], 'conditions': ['SARS-CoV-2 Infection']}, 'referencesModule': {'references': [{'pmid': '32946786', 'type': 'BACKGROUND', 'citation': 'Kreer C, Zehner M, Weber T, Ercanoglu MS, Gieselmann L, Rohde C, Halwe S, Korenkov M, Schommers P, Vanshylla K, Di Cristanziano V, Janicki H, Brinker R, Ashurov A, Krahling V, Kupke A, Cohen-Dvashi H, Koch M, Eckert JM, Lederer S, Pfeifer N, Wolf T, Vehreschild MJGT, Wendtner C, Diskin R, Gruell H, Becker S, Klein F. Longitudinal Isolation of Potent Near-Germline SARS-CoV-2-Neutralizing Antibodies from COVID-19 Patients. Cell. 2020 Sep 17;182(6):1663-1673. doi: 10.1016/j.cell.2020.08.046. No abstract available.'}, {'pmid': '34473343', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This is the first-in-human phase 1/2a trial of the intravenous administration of the SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and SARS-CoV-2-infected individuals. It will evaluate the safety, pharmacokinetic profile, immunogenicity, and antiviral activity of DZIF-10c.', 'detailedDescription': 'The phase 1 component of this trial consists of a single intravenous infusion open-label dose-escalation phase (Groups 1A-1D and Group 2C). Subsequently, the highest tested and tolerated dose will be administered to an expansion cohort of SARS-CoV-2-infected individuals (Group 2D). In this randomized and blinded group, participants will receive DZIF-10c or placebo by intravenous infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroups 1A-1D\n\n* Age 18-65.\n* SARS-CoV-2-RNA negative naso- or oropharyngeal swab obtained within 3 calendar days before study drug administration by NAAT (e.g., qRT-PCR).\n* Non-reactivity of serum antibodies (IgG; and IgA and/or IgM when tested) against SARS-CoV-2 by serological assay at screening.\n\nGroups 2C-2D\n\n* Age 18-70.\n* SARS-CoV-2-RNA positive naso- or oropharyngeal swab obtained within 3 calendar days before study drug administration by NAAT (e.g., qRT-PCR).\n* Onset of COVID-19 symptoms (e.g., sore throat, cough, fever, chills, fatigue, dys- or anosmia, dys- or ageusia, headache, muscle pain, gastrointestinal symptoms) within 7 days prior to study drug administration or Non-reactivity of serum or plasma antibodies (IgG; and IgA and/or IgM when tested) against SARS-CoV-2 by serological assay at screening.\n* Disease severity score 1-4 as defined by the WHO Clinical Progression Scale (WHO, Lancet Inf Dis 2020).\n\nExclusion Criteria (all groups):\n\n* Known hypersensitivity to any constituent of the investigational medicinal product.\n* Hepatitis B infection indicated by detectable HBsAg (Hepatitis B surface antigen) in blood.\n* Detectable antibodies against hepatitis C virus in blood unless active hepatitis C is ruled out by negative HCV-RNA.\n* HIV infection indicated by detectable HIV antigen and/or HIV antibodies in blood.\n* Neutrophil count ≤1,000 cells/µl\n* Hemoglobin ≤10 g/dl\n* Platelet count ≤100,000 cells/µl\n* ALT ≥2.0 x ULN\n* AST ≥2.0 x ULN\n* Total bilirubin ≥1.5 ULN\n* eGFR \\<60 ml/min/1.73m2\n* Pregnancy or lactation.\n* Any vaccination within 14 days prior to DZIF-10c administration.\n* Receipt of any SARS-CoV-2 vaccine or SARS-CoV-2 monoclonal antibody in the past.\n* Diagnosis of bronchial asthma or history of bronchial hyperresponsiveness, COPD, pulmonary fibrosis, or other chronic lung diseases.\n* Any chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer.\n* History of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months (a single administration of systemic corticosteroids within ≤6 months and ≥4 weeks of enrollment is acceptable).\n* Participation in another clinical trial of an investigational medicinal product within the past 12 weeks or expected participation during this study.\n* Dependency on the principal investigator or study staff; or site personnel directly affiliated with this trial.\n* Legally incapacitated individuals\n* Individuals held in an institution by legal or official order\n* If engaging in sexual activity that could result in pregnancy, inability or unwillingness to comply with the requirements for highly effective contraception'}, 'identificationModule': {'nctId': 'NCT04631666', 'briefTitle': 'SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Infusion', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'A Phase 1/2a Trial of the Intravenous Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals', 'orgStudyIdInfo': {'id': 'Uni-Koeln-4288'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1A (uninfected) - 2.5 mg/kg', 'description': 'SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 2.5 mg/kg', 'interventionNames': ['Biological: DZIF-10c']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1B (uninfected) - 10 mg/kg', 'description': 'SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 10 mg/kg', 'interventionNames': ['Biological: DZIF-10c']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1C (uninfected) - 40 mg/kg', 'description': 'SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 40 mg/kg', 'interventionNames': ['Biological: DZIF-10c']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1D (uninfected) - high dose', 'description': 'SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose higher than 40 mg/kg', 'interventionNames': ['Biological: DZIF-10c']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2C (infected) - 40 mg/kg', 'description': 'SARS-CoV-2-infected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 40 mg/kg', 'interventionNames': ['Biological: DZIF-10c']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2D (infected) - 40 mg/kg', 'description': 'SARS-CoV-2-infected volunteers will be randomized 2:1 to receive an intravenous infusion of DZIF-10c at a dose of 40 mg/kg or placebo', 'interventionNames': ['Biological: DZIF-10c', 'Other: Placebo']}], 'interventions': [{'name': 'DZIF-10c', 'type': 'BIOLOGICAL', 'description': 'SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion', 'armGroupLabels': ['Group 1A (uninfected) - 2.5 mg/kg', 'Group 1B (uninfected) - 10 mg/kg', 'Group 1C (uninfected) - 40 mg/kg', 'Group 1D (uninfected) - high dose', 'Group 2C (infected) - 40 mg/kg', 'Group 2D (infected) - 40 mg/kg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Intravenous infusion of sterile normal saline (NaCl 0.9%) as placebo', 'armGroupLabels': ['Group 2D (infected) - 40 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Gerd Fätkenheuer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cologne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZKS Köln', 'class': 'OTHER'}, {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Florian Klein', 'investigatorAffiliation': 'University of Cologne'}}}}