Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-03-03 @ 4:07 AM
Study NCT ID:
NCT02989194
Status:
COMPLETED
Last Update Posted:
2022-08-15
First Post:
2016-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of an Investigational Monoclonal Antibody, VIS410, in Subjects With Uncomplicated Influenza A
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': 'clinicaltrials@visterrainc.com', 'phone': '617-498-1070', 'title': 'Chief Medical Officer', 'organization': 'Visterra'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored continuously from signing of informed consent until the last study related activity (100 days).', 'description': 'New or worsening symptoms of influenza, including cough, sore throat, nasal congestion, fatigue, headache, myalgia or low-grade fever were in general, considered a component of the presenting illness, and were not reported as AEs unless they resulted in an SAE', 'eventGroups': [{'id': 'EG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 16, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 10, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Single intravenous saline solution', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 7, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous dose of 2000 mg VIS410'}, {'id': 'OG002', 'title': 'VIS410 Total', 'description': 'Summation of the VIS410 high and low dose groups.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single intravenous dose of saline solution'}], 'classes': [{'title': 'Percentage of subjects with any adverse events', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '42.21', 'upperLimit': '71.18'}, {'value': '34.7', 'groupId': 'OG001', 'lowerLimit': '21.67', 'upperLimit': '49.64'}, {'value': '45.9', 'groupId': 'OG002', 'lowerLimit': '35.80', 'upperLimit': '56.29'}, {'value': '26.0', 'groupId': 'OG003', 'lowerLimit': '14.63', 'upperLimit': '40.34'}]}]}, {'title': 'Percentage of subjects with any serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '7.25'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '7.25'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.69'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '0.49', 'upperLimit': '13.71'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 days', 'description': 'The percentage of participants with adverse events (AEs) and serious adverse events (SAEs) following administration of a single dose of IV VIS410.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population The safety population included all subjects randomized who received IV study drug. The safety population summaries were based on the actual treatment received.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}, {'id': 'OG002', 'title': 'Total VIS410', 'description': 'Summation of 4000 mg and 2000 mg VIS410 dose groups.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single intravenous saline solution'}], 'classes': [{'title': 'Percentage of subjects with any TEAE', 'categories': [{'measurements': [{'value': '55.1', 'groupId': 'OG000', 'lowerLimit': '40.23', 'upperLimit': '69.33'}, {'value': '34.7', 'groupId': 'OG001', 'lowerLimit': '21.67', 'upperLimit': '49.64'}, {'value': '44.9', 'groupId': 'OG002', 'lowerLimit': '34.83', 'upperLimit': '55.28'}, {'value': '24.0', 'groupId': 'OG003', 'lowerLimit': '13.06', 'upperLimit': '38.17'}]}]}, {'title': 'Percentage of subjects with treatment related TEAEs', 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000', 'lowerLimit': '18.25', 'upperLimit': '45.42'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '5.94', 'upperLimit': '27.24'}, {'value': '22.4', 'groupId': 'OG002', 'lowerLimit': '14.64', 'upperLimit': '31.99'}, {'value': '12.0', 'groupId': 'OG003', 'lowerLimit': '4.53', 'upperLimit': '24.31'}]}]}, {'title': 'Percentage of subjects with any TEAEs of Special Interest', 'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000', 'lowerLimit': '21.67', 'upperLimit': '49.64'}, {'value': '16.3', 'groupId': 'OG001', 'lowerLimit': '7.32', 'upperLimit': '29.66'}, {'value': '25.5', 'groupId': 'OG002', 'lowerLimit': '17.24', 'upperLimit': '35.31'}, {'value': '12', 'groupId': 'OG003', 'lowerLimit': '4.53', 'upperLimit': '24.31'}]}]}, {'title': 'Percentage of Subjects with any hypersensitivity Reactions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '7.25'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '7.25'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '3.69'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '7.11'}]}]}, {'title': 'Percentage of subjects with any anaphylactic reactions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '7.25'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '7.25'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '3.69'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '7.11'}]}]}, {'title': 'Percentage of subjects with any injection site AEs.', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '10.85'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '7.25'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '5.55'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '7.11'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 days', 'description': 'Percentage of participants experiencing any TEAE, TEAEs considered related to study treatment and the number of participants experiencing adverse events of special interest (AESI). A TEAE is defined as an adverse event that starts on or after the date of study drug IV infusion. AESIs included hypersensitivity reaction, anaphylactic reaction, or injection site adverse event.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. The safety population included all participants randomized who received IV study drug. The safety population summaries were based on the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous dose of 2000 mg VIS410'}, {'id': 'OG002', 'title': 'VIS410 Total', 'description': 'Summation of the 4000 and 2000 mg dose groups'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose intravenous saline solution'}], 'classes': [{'title': 'Percent Change from Baseline to Day 2', 'categories': [{'measurements': [{'value': '-26.12', 'spread': '27.00', 'groupId': 'OG000'}, {'value': '-29.98', 'spread': '29.55', 'groupId': 'OG001'}, {'value': '-28.01', 'spread': '28.18', 'groupId': 'OG002'}, {'value': '-19.53', 'spread': '26.51', 'groupId': 'OG003'}]}]}, {'title': 'Percentage change from baseline to day 3', 'categories': [{'measurements': [{'value': '-38.65', 'spread': '28.78', 'groupId': 'OG000'}, {'value': '-49.37', 'spread': '29.62', 'groupId': 'OG001'}, {'value': '-43.89', 'spread': '29.53', 'groupId': 'OG002'}, {'value': '-33.63', 'spread': '23.60', 'groupId': 'OG003'}]}]}, {'title': 'Percentage change from baseline to day 4', 'categories': [{'measurements': [{'value': '-53.46', 'spread': '26.16', 'groupId': 'OG000'}, {'value': '-59.08', 'spread': '31.12', 'groupId': 'OG001'}, {'value': '-56.21', 'spread': '28.67', 'groupId': 'OG002'}, {'value': '-44.55', 'spread': '28.20', 'groupId': 'OG003'}]}]}, {'title': 'Percentage change from baseline to day 5', 'categories': [{'measurements': [{'value': '-60.85', 'spread': '25.52', 'groupId': 'OG000'}, {'value': '-64.61', 'spread': '29.91', 'groupId': 'OG001'}, {'value': '-62.69', 'spread': '27.66', 'groupId': 'OG002'}, {'value': '-56.75', 'spread': '24.31', 'groupId': 'OG003'}]}]}, {'title': 'Percentage change from baseline to day 6', 'categories': [{'measurements': [{'value': '-69.31', 'spread': '20.90', 'groupId': 'OG000'}, {'value': '-66.80', 'spread': '33.42', 'groupId': 'OG001'}, {'value': '-68.08', 'spread': '27.61', 'groupId': 'OG002'}, {'value': '64.01', 'spread': '23.35', 'groupId': 'OG003'}]}]}, {'title': 'Percentage change from baseline to day 7', 'categories': [{'measurements': [{'value': '-74.03', 'spread': '19.31', 'groupId': 'OG000'}, {'value': '-70.76', 'spread': '31.18', 'groupId': 'OG001'}, {'value': '-72.43', 'spread': '25.71', 'groupId': 'OG002'}, {'value': '-71.51', 'spread': '20.61', 'groupId': 'OG003'}]}]}, {'title': 'Percentage change from baseline to day 8', 'categories': [{'measurements': [{'value': '-77.98', 'spread': '20.76', 'groupId': 'OG000'}, {'value': '-76.03', 'spread': '25.53', 'groupId': 'OG001'}, {'value': '-77.02', 'spread': '23.13', 'groupId': 'OG002'}, {'value': '-76.16', 'spread': '21.01', 'groupId': 'OG003'}]}]}, {'title': 'Percentage change from baseline to day 9', 'categories': [{'measurements': [{'value': '-80.05', 'spread': '19.78', 'groupId': 'OG000'}, {'value': '-78.48', 'spread': '25.95', 'groupId': 'OG001'}, {'value': '-79.27', 'spread': '22.91', 'groupId': 'OG002'}, {'value': '-79.52', 'spread': '19.84', 'groupId': 'OG003'}]}]}, {'title': 'Percentage change from baseline to day 10', 'categories': [{'measurements': [{'value': '-82.30', 'spread': '20.07', 'groupId': 'OG000'}, {'value': '-81.38', 'spread': '20.43', 'groupId': 'OG001'}, {'value': '-81.85', 'spread': '20.14', 'groupId': 'OG002'}, {'value': '-84.35', 'spread': '17.52', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.158', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.', 'groupDescription': 'Percent Change from Baseline to Day 2. All null hypotheses were defined as no treatment difference.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.'}, {'pValue': '0.025', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.', 'groupDescription': 'Percent Change from Baseline to Day 3. All null hypotheses were defined as no treatment difference.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.'}, {'pValue': '0.007', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.', 'groupDescription': 'Percent Change from Baseline to Day 4. All null hypotheses were defined as no treatment difference.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.'}, {'pValue': '0.061', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.', 'groupDescription': 'Percent Change from Baseline to Day 5. All null hypotheses were defined as no treatment difference.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.'}, {'pValue': '0.107', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.', 'groupDescription': 'Percent Change from Baseline to Day 6. All null hypotheses were defined as no treatment difference.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.'}, {'pValue': '0.237', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.', 'groupDescription': 'Percent Change from Baseline to Day 7. All null hypotheses were defined as no treatment difference.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.'}, {'pValue': '0.497', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.', 'groupDescription': 'Percent Change from Baseline to Day 8. All null hypotheses were defined as no treatment difference.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.'}, {'pValue': '0.704', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.', 'groupDescription': 'Percent Change from Baseline to Day 9. All null hypotheses were defined as no treatment difference.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.'}, {'pValue': '0.585', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.', 'groupDescription': 'Percent Change from Baseline to Day 10. All null hypotheses were defined as no treatment difference.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.'}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. These data were summarized at each visit by treatment group. The data below show the percent change in mean total symptom scores over time by treatment arm.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population. The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.'}, {'type': 'SECONDARY', 'title': 'Hospitalization for Influenza-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}, {'id': 'OG002', 'title': 'VIS410 Total', 'description': 'Summation of 4000 and 2000 mg VIS410 dose groups'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single intravenous saline solution'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '100 days', 'description': 'Number of participants requiring hospitalization for influenza-related complications', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.'}, {'type': 'SECONDARY', 'title': 'Duration of Hospitalization for Complications of Influenza', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}, {'id': 'OG002', 'title': 'VIS410 Total', 'description': 'Summation of 4000 and 2000 mg VIS410 dose groups.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single intravenous saline solution'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 days', 'description': 'Duration of hospitalization for participants with at least 1 complication of influenza. There were no participants hospitalized for complications of influenza.', 'unitOfMeasure': 'days', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population. The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.'}, {'type': 'SECONDARY', 'title': 'Count of Participants With Complications of Influenza', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}, {'id': 'OG002', 'title': 'VIS410 Total', 'description': 'Summation of 4000 and 2000 mg VIS410 dose groups.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single intravenous saline solution'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '11.53'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1.43', 'upperLimit': '18.66'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1.22', 'upperLimit': '10.99'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': '1.31', 'upperLimit': '17.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 days', 'description': 'Count of participants with at least 1 complication of influenza', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population. The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.'}, {'type': 'SECONDARY', 'title': 'Influenza A Relapse/Reinfection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}, {'id': 'OG002', 'title': 'VIS410 Total', 'description': 'Summation of 4000 and 2000 mg VIS410 dose groups.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single intravenous saline solution'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '100 days', 'description': 'Number of participants with influenza A relapse/reinfection', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.'}, {'type': 'SECONDARY', 'title': 'VIS410 Maximum Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}], 'classes': [{'categories': [{'measurements': [{'value': '1013.559', 'spread': '35.5', 'groupId': 'OG000'}, {'value': '627.640', 'spread': '54.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1, 3, 5, 7, 14, 28, 56, 100 days', 'description': 'The maximum observed concentration of VIS410 in serum (Cmax).', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetics (PK) population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of VIS410 Concentration in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}], 'classes': [{'categories': [{'measurements': [{'value': '0.119', 'spread': '79.0624', 'groupId': 'OG000'}, {'value': '0.133', 'spread': '131.4255', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1, 3, 5, 7, 14, 28, 56, 100 days', 'description': 'Time corresponding to the maximum serum concentration of VIS410.', 'unitOfMeasure': 'day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated'}, {'type': 'SECONDARY', 'title': 'VIS410 Plasma Concentration ( AUC 0-infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}], 'classes': [{'categories': [{'measurements': [{'value': '8598.909', 'spread': '38.3172', 'groupId': 'OG000'}, {'value': '5371.988', 'spread': '30.0631', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1, 3, 5, 7, 14, 28, 56, 100 days', 'description': 'VIS410 area under the plasma concentration time curve in serum. AUC 0-infinity is from the time of dosing extrapolated to infinity.', 'unitOfMeasure': 'day*mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated'}, {'type': 'SECONDARY', 'title': 'VIS410 Plasma Concentration (AUC 0-last)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}], 'classes': [{'categories': [{'measurements': [{'value': '8441.244', 'spread': '39.5852', 'groupId': 'OG000'}, {'value': '5385.491', 'spread': '31.2065', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1, 3, 5, 7, 14, 28, 56, 100 days', 'description': 'VIS410 area under the plasma concentration time curve in serum. AUC 0-last is the area under the plasma concentration time curve from time 0 to the last measurable concentration.', 'unitOfMeasure': 'day*mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated'}, {'type': 'SECONDARY', 'title': 'Half-life of VIS410 in Serum.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}], 'classes': [{'categories': [{'measurements': [{'value': '9.941', 'spread': '40.6241', 'groupId': 'OG000'}, {'value': '10.119', 'spread': '34.2559', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1, 3, 5, 7, 14, 28, 56, 100 days', 'description': 'Terminal elimination half-life of VIS410 in serum (t1/2) in serum.', 'unitOfMeasure': 'day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) of VIS410 in Serum.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}], 'classes': [{'categories': [{'measurements': [{'value': '465.175', 'spread': '38.3172', 'groupId': 'OG000'}, {'value': '372.302', 'spread': '30.0631', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1, 3, 5, 7, 14, 28, 56, 100 days', 'description': 'Summary of VIS410 total clearance (CL) in serum.', 'unitOfMeasure': 'mL/day', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated.'}, {'type': 'SECONDARY', 'title': 'Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}, {'id': 'OG002', 'title': 'VIS410 Total', 'description': 'Summation of 4000 and 2000 mg VIS410 dose groups.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single intravenous saline solution'}], 'classes': [{'categories': [{'measurements': [{'value': '3.726', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '14.44'}, {'value': '3.570', 'groupId': 'OG001', 'lowerLimit': '0.14', 'upperLimit': '13.37'}, {'value': '3.660', 'groupId': 'OG002', 'lowerLimit': '0.14', 'upperLimit': '14.44'}, {'value': '4.782', 'groupId': 'OG003', 'lowerLimit': '0.28', 'upperLimit': '16.57'}]}]}], 'analyses': [{'pValue': '0.083', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'A t-test was used to assess the difference between the VIS410 total and placebo treatment groups from nasopharyngeal swabs based on the TCID50.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.'}], 'paramType': 'MEDIAN', 'timeFrame': '7 days', 'description': 'The difference between VIS410 and placebo treatment groups in viral AUC based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.', 'unitOfMeasure': 'd x log10 TCID50/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.'}, {'type': 'SECONDARY', 'title': 'Peak Viral Load by TCID50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}, {'id': 'OG002', 'title': 'VIS410 Total', 'description': 'Summation of 4000 and 2000 mg VIS410 dose groups.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single intravenous saline solution'}], 'classes': [{'categories': [{'measurements': [{'value': '3.125', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '5.75'}, {'value': '2.50', 'groupId': 'OG001', 'lowerLimit': '0.38', 'upperLimit': '4.75'}, {'value': '2.625', 'groupId': 'OG002', 'lowerLimit': '0.38', 'upperLimit': '5.75'}, {'value': '3.375', 'groupId': 'OG003', 'lowerLimit': '0.38', 'upperLimit': '6.75'}]}]}], 'analyses': [{'pValue': '0.169', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.', 'groupDescription': 'The null hypothesis was defined as no treatment difference.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.'}], 'paramType': 'MEDIAN', 'timeFrame': '7 days', 'description': 'The difference between VIS410 and placebo treatment groups in peak viral load based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.', 'unitOfMeasure': 'log10 TCID50/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.'}, {'type': 'SECONDARY', 'title': 'Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}, {'id': 'OG002', 'title': 'VIS649 Total', 'description': 'Summation of 4000 and 2000 mg VIS410 dose groups.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single intravenous saline solution'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.81', 'upperLimit': '2.90'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.83', 'upperLimit': '2.87'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '1.84', 'upperLimit': '2.10'}, {'value': '3.6', 'groupId': 'OG003', 'lowerLimit': '1.83', 'upperLimit': '3.85'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.', 'groupDescription': 'Kaplan-Meier methods were used to calculate the median time. All null hypotheses were defined as no treatment difference.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Descriptive Statistics. Statistical comparisons were performed using log rank test.', 'otherAnalysisDescription': 'All statistical comparisons were performed using 2-sided tests at the 0.05 significance level, unless specifically stated otherwise. All null hypotheses were defined as no treatment difference. All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.'}], 'paramType': 'MEDIAN', 'timeFrame': '7 days', 'description': 'The number of days for the median time to resolution of peak viral load from end of infusion by nasopharyngeal swabs collected from the first 50 participants and tested by half maximal tissue culture infective dose (TCID50)', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.'}, {'type': 'SECONDARY', 'title': 'Summary of Anti-VIS410 Antibody (ADA) Titers.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}, {'id': 'OG002', 'title': 'VIS410 Total', 'description': 'All participants receiving VIS410'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single intravenous saline solution'}], 'classes': [{'title': 'Visit day 1 anti-VIS410 antibody titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'title': 'ADA Titer ≤ 1', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}, {'title': 'ADA Titer > 1 to 4', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'ADA Titer > 4 to 16', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'ADA Titer > 16 to 64', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'ADA Titer > 64', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 14 anti-VIS410 antibody titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'title': 'ADA Titer ≤ 1', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'ADA Titer > 1 to 4', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'ADA Titer > 4 to 16', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'ADA Titer > 16 to 64', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'ADA Titer > 64', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 56 anti-VIS410 antibody titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'title': 'ADA Titer ≤ 1', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': 'ADA Titer > 1 to 4', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'ADA Titer > 4 to 16', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'ADA Titer > 16 to 64', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'ADA Titer > 64', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 100 anti-VIS410 antibody titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'title': 'ADA Titer ≤ 1', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}, {'title': 'ADA Titer > 1 to 4', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'ADA Titer > 4 to 16', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'ADA Titer > 16 to 64', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'ADA Titer > 64', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '100 days', 'description': 'Count of subjects testing positive for anti-VIS410 antibodies on days 1, 14, 56 and 100. A positive result includes samples confirmed positive and above titer cut point factor (and titer ≥ 1). Negative results include screened or confirmed negative or confirmed positive but below titer cut point factor (titer \\< 1). For participants receiving placebo, only samples from two participants were tested at Days 14 and 56.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population The safety population included all ITT subjects who received IV study drug. The safety population summaries were based on the actual treatment received. Not all participants had samples for all timepoints. For participants receiving placebo, all participants were tested on Day 1 and Day 100; only samples from two participants were tested at Days 14 and 56.'}, {'type': 'SECONDARY', 'title': 'Duration of Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous dose of 4000 mg VIS410'}, {'id': 'OG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous dose of 2000 mg VIS410'}, {'id': 'OG002', 'title': 'VIS410 Total', 'description': 'Summation of the 4000 and 2000 mg dose groups'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose intravenous saline solution'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '4.1'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '3.8'}, {'value': '2.6', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '4.0'}]}]}], 'analyses': [{'pValue': '0.173', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.', 'groupDescription': 'All null hypotheses were defined as no treatment difference.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Kaplan-Meier methods were used to calculate the median time, 25th percentile and 75th percentile.', 'nonInferiorityComment': 'Descriptive Statistics. All statistical comparisons were performed at the 0.05 significance level.'}], 'paramType': 'MEDIAN', 'timeFrame': '10 days', 'description': 'The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. Data below show the time to symptom resolution for Total Symptom Score.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population. The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'FG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Single intravenous saline solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Study on hold for safety and participant was withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was initiated in 58 study centers; 28 sites enrolled at least 1 subject.', 'preAssignmentDetails': 'When required, subject may have been given a pre-screening informed consent to perform a Rapid Antigen Test for influenza. Flu-positive subjects were given a full explanation of the nature of the study and written informed consent (approved by local ethics committee) was obtained according to local requirements before any study related assessments'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'VIS410 High Dose', 'description': 'Single intravenous fixed dose of 4000 mg VIS410'}, {'id': 'BG001', 'title': 'VIS410 Low Dose', 'description': 'Single intravenous fixed dose of 2000 mg VIS410'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Single intravenous saline solution'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '40.3', 'spread': '13.13', 'groupId': 'BG000'}, {'value': '39.6', 'spread': '13.79', 'groupId': 'BG001'}, {'value': '43.1', 'spread': '12.77', 'groupId': 'BG002'}, {'value': '41.0', 'spread': '13.23', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', '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': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Latvia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}, {'title': 'South Africa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}, {'title': 'Estonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Bulgaria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Subjects Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '29.01', 'groupId': 'BG000', 'lowerLimit': '19.4', 'upperLimit': '48.0'}, {'value': '30.80', 'groupId': 'BG001', 'lowerLimit': '16.7', 'upperLimit': '55.6'}, {'value': '28.82', 'groupId': 'BG002', 'lowerLimit': '18.0', 'upperLimit': '43.1'}, {'value': '29.54', 'groupId': 'BG003', 'lowerLimit': '16.7', 'upperLimit': '55.6'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time since onset of influenza (hours)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '148', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '43.31', 'spread': '16.479', 'groupId': 'BG000'}, {'value': '40.57', 'spread': '11.563', 'groupId': 'BG001'}, {'value': '38.19', 'spread': '13.859', 'groupId': 'BG002'}, {'value': '40.67', 'spread': '14.170', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participant was omitted if the date/time of symptom onset was missing.'}, {'title': 'Time since onset of influenza (hours)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '148', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '27.69', 'groupId': 'BG000', 'lowerLimit': '19.4', 'upperLimit': '48.0'}, {'value': '28.88', 'groupId': 'BG001', 'lowerLimit': '16.7', 'upperLimit': '55.6'}, {'value': '28.07', 'groupId': 'BG002', 'lowerLimit': '18.0', 'upperLimit': '43.1'}, {'value': '28.60', 'groupId': 'BG003', 'lowerLimit': '16.7', 'upperLimit': '55.6'}]}]}], 'paramType': 'MEDIAN', 'description': 'Median time since onset of influenza in hours.', 'unitOfMeasure': 'hours', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Participants who did not have a start date/time for symptom onset were excluded.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-14', 'size': 1791557, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-11-22T14:06', 'hasProtocol': True}, {'date': '2018-01-05', 'size': 3292628, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-11-22T14:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-11', 'studyFirstSubmitDate': '2016-12-05', 'resultsFirstSubmitDate': '2020-05-20', 'studyFirstSubmitQcDate': '2016-12-07', 'lastUpdatePostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-11', 'studyFirstPostDateStruct': {'date': '2016-12-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection', 'timeFrame': '100 days', 'description': 'The percentage of participants with adverse events (AEs) and serious adverse events (SAEs) following administration of a single dose of IV VIS410.'}, {'measure': 'Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest', 'timeFrame': '100 days', 'description': 'Percentage of participants experiencing any TEAE, TEAEs considered related to study treatment and the number of participants experiencing adverse events of special interest (AESI). A TEAE is defined as an adverse event that starts on or after the date of study drug IV infusion. AESIs included hypersensitivity reaction, anaphylactic reaction, or injection site adverse event.'}], 'secondaryOutcomes': [{'measure': 'Percentage Change From Baseline in Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410', 'timeFrame': '10 days', 'description': 'The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. These data were summarized at each visit by treatment group. The data below show the percent change in mean total symptom scores over time by treatment arm.'}, {'measure': 'Hospitalization for Influenza-related Complications', 'timeFrame': '100 days', 'description': 'Number of participants requiring hospitalization for influenza-related complications'}, {'measure': 'Duration of Hospitalization for Complications of Influenza', 'timeFrame': '100 days', 'description': 'Duration of hospitalization for participants with at least 1 complication of influenza. There were no participants hospitalized for complications of influenza.'}, {'measure': 'Count of Participants With Complications of Influenza', 'timeFrame': '100 days', 'description': 'Count of participants with at least 1 complication of influenza'}, {'measure': 'Influenza A Relapse/Reinfection', 'timeFrame': '100 days', 'description': 'Number of participants with influenza A relapse/reinfection'}, {'measure': 'VIS410 Maximum Plasma Concentration', 'timeFrame': '1, 3, 5, 7, 14, 28, 56, 100 days', 'description': 'The maximum observed concentration of VIS410 in serum (Cmax).'}, {'measure': 'Pharmacokinetics of VIS410 Concentration in Serum', 'timeFrame': '1, 3, 5, 7, 14, 28, 56, 100 days', 'description': 'Time corresponding to the maximum serum concentration of VIS410.'}, {'measure': 'VIS410 Plasma Concentration ( AUC 0-infinity)', 'timeFrame': '1, 3, 5, 7, 14, 28, 56, 100 days', 'description': 'VIS410 area under the plasma concentration time curve in serum. AUC 0-infinity is from the time of dosing extrapolated to infinity.'}, {'measure': 'VIS410 Plasma Concentration (AUC 0-last)', 'timeFrame': '1, 3, 5, 7, 14, 28, 56, 100 days', 'description': 'VIS410 area under the plasma concentration time curve in serum. AUC 0-last is the area under the plasma concentration time curve from time 0 to the last measurable concentration.'}, {'measure': 'Half-life of VIS410 in Serum.', 'timeFrame': '1, 3, 5, 7, 14, 28, 56, 100 days', 'description': 'Terminal elimination half-life of VIS410 in serum (t1/2) in serum.'}, {'measure': 'Clearance (CL) of VIS410 in Serum.', 'timeFrame': '1, 3, 5, 7, 14, 28, 56, 100 days', 'description': 'Summary of VIS410 total clearance (CL) in serum.'}, {'measure': 'Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.', 'timeFrame': '7 days', 'description': 'The difference between VIS410 and placebo treatment groups in viral AUC based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.'}, {'measure': 'Peak Viral Load by TCID50', 'timeFrame': '7 days', 'description': 'The difference between VIS410 and placebo treatment groups in peak viral load based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.'}, {'measure': 'Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.', 'timeFrame': '7 days', 'description': 'The number of days for the median time to resolution of peak viral load from end of infusion by nasopharyngeal swabs collected from the first 50 participants and tested by half maximal tissue culture infective dose (TCID50)'}, {'measure': 'Summary of Anti-VIS410 Antibody (ADA) Titers.', 'timeFrame': '100 days', 'description': 'Count of subjects testing positive for anti-VIS410 antibodies on days 1, 14, 56 and 100. A positive result includes samples confirmed positive and above titer cut point factor (and titer ≥ 1). Negative results include screened or confirmed negative or confirmed positive but below titer cut point factor (titer \\< 1). For participants receiving placebo, only samples from two participants were tested at Days 14 and 56.'}, {'measure': 'Duration of Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410', 'timeFrame': '10 days', 'description': 'The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. Data below show the time to symptom resolution for Total Symptom Score.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '30638863', 'type': 'RESULT', 'citation': 'Hershberger E, Sloan S, Narayan K, Hay CA, Smith P, Engler F, Jeeninga R, Smits S, Trevejo J, Shriver Z, Oldach D. Safety and efficacy of monoclonal antibody VIS410 in adults with uncomplicated influenza A infection: Results from a randomized, double-blind, phase-2, placebo-controlled study. EBioMedicine. 2019 Feb;40:574-582. doi: 10.1016/j.ebiom.2018.12.051. Epub 2019 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 2a randomized, double-blind, placebo-controlled study designed to assess the safety and tolerability of an investigational monoclonal antibody, VIS410, in subjects with uncomplicated influenza.', 'detailedDescription': 'Subjects will be admitted to an infusion unit for drug administration and observation following infusion. The study is designed to compare an infusion of a single high or low IV dose of VIS410 against placebo. Subjects will be followed for 100 (±7 days).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female subjects aged ≥18 years and ˂65 years\n* Women should fulfill one of the following criteria:\n\n 1. Post-menopausal; either amenorrhea ≥12 months or follicle stimulating hormone \\>40 mIU/mL (milli-international units/milliliter) as documented in their medical history\n 2. Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation\n 3. Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception from screening until 60 days post infusion\n* Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects who have a female partner of childbearing potential must use an effective birth control method when having heterosexual intercourse, from screening until 60 days post infusion\n* Test positive for influenza A by Rapid Antigen Test performed with a commercially available test on an adequate nasopharyngeal specimen in accordance with the manufacturer's instructions\n* Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of moderate to severe intensity, or presence of at least one constitutional symptom (myalgia \\[aches and pains\\], headache, feverishness, or fatigue) of moderate to severe intensity\n* Onset of symptoms (time when the temperature was first measured as elevated \\[temperature of ≥100.4°F or ≥38°C\\], OR the time when the subject experienced at least one respiratory symptom or at least one constitutional symptom) no more than 72 hours before the start of infusion\n\nExclusion Criteria:\n\n* Use of NSAIDs or antihistamines within 6 hours of study drug dosing with the exception of those used as part of the pretreatment regimen\n* History of intolerance or allergic response to monoclonal antibodies and/or pretreatment medications (diphenhydramine, ibuprofen and acetylsalicylic acid)\n* Subject weight less than (\\<) 45 kg\n* Subjects with clinical history that would lead to increased risk of influenza complications including but not limited to clinically significant cardiac disease, moderate to severe asthma, or other moderate to severe chronic obstructive pulmonary disease, metabolic syndrome including moderate to severe diabetes or active tuberculosis\n* History of chronic GI disease, including bleeding, ulceration, Irritable Bowel Syndrome, systemic mastocytosis or chronic diarrhea\n* Women who are pregnant, breast-feeding, or considering becoming pregnant\n* Patients with hypoxemia requiring oxygen support\n* Clinical evidence of worsening of any chronic medical condition (temporally associated with the onset of symptoms of influenza) which, in the Investigator's opinion, indicates that such finding(s) could represent complications of influenza\n* Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy including systemic steroids\n* Presence of known Acquired Immune Deficiency Syndrome-defining illness, chronic hepatitis B or hepatitis C\n* Receipt of any dose of antiviral therapy such as, but not limited to, rimantadine, amantadine, peramivir, zanamivir, laninamivir or oseltamivir in the 7 days prior to screening\n* Enrollment in any other investigational drug or device study, any disease or vaccine study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer\n* Subjects unable to take oral predose medication\n* Known or suspected alcohol or drug abuse, that is, abuse of a level that would compromise the safety or cooperation of the subject in the opinion of the Investigator\n* Subjects on chronic medications where the dose has not been stable for at least 3 months"}, 'identificationModule': {'nctId': 'NCT02989194', 'briefTitle': 'Study of an Investigational Monoclonal Antibody, VIS410, in Subjects With Uncomplicated Influenza A', 'organization': {'class': 'INDUSTRY', 'fullName': 'Visterra, Inc.'}, 'officialTitle': 'A Phase 2a Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability of a Single Intravenous Dose of an Investigational Monoclonal Antibody With Code Name VIS410 in Subjects With Uncomplicated Influenza A Infection', 'orgStudyIdInfo': {'id': 'VIS410-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VIS410 low dose', 'description': 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