<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03040141</url>
  </required_header>
  <id_info>
    <org_study_id>VIS410-203</org_study_id>
    <nct_id>NCT03040141</nct_id>
  </id_info>
  <brief_title>Study of Efficacy and Safety of IV VIS410 Plus Oseltamivir Versus Oseltamivir in Hospitalized Adults With Influenza A</brief_title>
  <official_title>Phase 2b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of IV VIS410 in Addition to Oseltamivir Compared With Oseltamivir Alone in Hospitalized Adults With Influenza A Infection Requiring Oxygen Support</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Visterra, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Visterra, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to compare the efficacy and safety of VIS410 in combination with oseltamivir vs&#xD;
      oseltamivir alone in severely ill subjects with influenza A infection requiring oxygen&#xD;
      support.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is to compare the efficacy and safety of VIS410 in combination with oseltamivir vs&#xD;
      oseltamivir alone in severely ill subjects with influenza A infection requiring oxygen&#xD;
      support. Subjects will be followed for 56 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2018</start_date>
  <completion_date type="Actual">November 22, 2018</completion_date>
  <primary_completion_date type="Actual">November 22, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Status of Participants on Day 7</measure>
    <time_frame>7 days</time_frame>
    <description>Evaluate the effect of 2 dose levels of VIS410 + oseltamivir on clinical status using a seven-level ordinal scale. Comparison between treatment groups and between all VIS410 recipients versus placebo were assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Participants With Adverse Events and Serious Adverse Events Following Administration of VIS410</measure>
    <time_frame>56 days</time_frame>
    <description>Safety and tolerability of 2 dose levels of a single intravenous (IV) dose of VIS410 when administered in combination with oseltamivir in hospitalized participants with influenza A infection. Data presents the count of participants who experienced an adverse event (AE) or serious treatment emergent adverse events (TEAE).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Cessation of Oxygen Support Compared to Oseltamivir Alone Among Patients Requiring Supplemental Oxygen Therapy With Baseline Room Air &lt;= 92%</measure>
    <time_frame>Baseline to Day 56</time_frame>
    <description>Time to cessation of O2 support in patients with supplemental oxygen with baseline room air &lt;= 92%. Patients with treatment resulting in a stable SpO2 by pulse oximetry. Stable SpO2 is defined as two consecutive SpO2 values of &gt;92% on room air that are at least 8 hours apart.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Cessation of Oxygen Support for Any Patient Requiring Supplemental Oxygen Therapy</measure>
    <time_frame>Baseline to Day 56</time_frame>
    <description>Time to cessation of oxygen support in all patients with supplemental oxygen (regardless of oxygen saturation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral Titer in Upper Respiratory Samples by qRT-PCR</measure>
    <time_frame>Day 14</time_frame>
    <description>The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in peak viral load by qRT-PCR from nasopharyngeal swabs through Day 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral Nasopharyngeal AUC</measure>
    <time_frame>Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5</time_frame>
    <description>The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in nasopharyngeal qRT-PCR area under the viral load-time curve (AUC) from baseline to Day 5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Viral Load-Time Curve (VL AUC) Based on qRT-PCR From Nasopharyngeal Swabs Through Day 7</measure>
    <time_frame>Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5, Day 7</time_frame>
    <description>The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in nasopharyngeal qRT-PCR area under the viral load-time curve (AUC) from baseline to Day 7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Viral Load-Time Curve (VL AUC) Based on qRT-PCR From Nasopharyngeal Swabs Through Day 14</measure>
    <time_frame>Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5, Day 7, Day 14</time_frame>
    <description>The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in nasopharyngeal qRT-PCR area under the viral load-time curve (AUC) from baseline to Day 14.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to Resolution of Viral Load by Treatment Arm by qRT-PCR - From End of Infusion</measure>
    <time_frame>14 days</time_frame>
    <description>Number of days from the end of infusion until virus is no longer detectable (at or below the limit of detection) with no samples following that are greater than the BLQ through the Day 14 (quantitative reverse-transcription polymerase chain reaction - qRT-PCR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by qRT-PCR</measure>
    <time_frame>14 days</time_frame>
    <description>Number of participants in whom peak viral load is observed post-baseline based on quantitative reverse-transcription polymerase chain reaction (qRT-PCR). Post-baseline was considered the day 3 sample or later.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Viral Load by TCID50</measure>
    <time_frame>Day 7</time_frame>
    <description>Peak viral load based on TCID50 from nasopharyngeal swabs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by TCID50</measure>
    <time_frame>56 days</time_frame>
    <description>Number of participants in whom peak viral load occurred post-baseline measured by TCID50. Post-baseline was considered the day 3 sample or later.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral Nasopharyngeal AUC by TCID50</measure>
    <time_frame>5 days</time_frame>
    <description>The area under the viral load-time curve (AUC) for VIS410 + oseltamivir and oseltamivir alone treatment groups from baseline to Day 5 measured by TCID50 from nasopharyngeal swabs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral Nasopharyngeal AUC by TCID50</measure>
    <time_frame>7 days</time_frame>
    <description>The area under the viral load-time curve (AUC) for VIS410 + oseltamivir and oseltamivir alone treatment groups from baseline to Day 7 measured by TCID50 from nasopharyngeal swabs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative Viral Cultures by Study Day</measure>
    <time_frame>Nominal days 3, 5, 7</time_frame>
    <description>Number of participants negative for viral titer by study day determined by TCID50 on nominal days 3, 5, 7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From End of Infusion</measure>
    <time_frame>7 Days</time_frame>
    <description>Number of days from the end of infusion until virus is no longer detectable (at or below the limit of detection) with no samples following that are greater than the BLQ through the Day 7 (TCID50)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From Onset of Symptoms</measure>
    <time_frame>7 Days</time_frame>
    <description>Number of days from the onset of symptoms until virus is no longer detectable (at or below the limit of detection) with no samples following that are greater than the BLQ through the Day 7 (TCID50)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Clinical Response (4 Out of 5 Vital Signs)</measure>
    <time_frame>Day 56</time_frame>
    <description>Median time to clinical response defined by resolution of at least 4 of 5 vital signs:&#xD;
Afebrile with core temperature ≤ 37.8°C, without use of antipyretics (oral ≤ 37.2°C)&#xD;
Oxygen saturation ≥ 95% on room air without support or a return to preinfection status, if pre-infection status was &lt; 95%&#xD;
Pulse rate ≤ 100/min&#xD;
Systolic blood pressure ≥ 90 mm/Hg, without vasopressor use&#xD;
Respiratory rate ≤ 24 beats per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Complete Clinical Response (Resolution of All Vital Signs)</measure>
    <time_frame>Day 56</time_frame>
    <description>Median time to clinical response defined by resolution of at all 5 vital signs:&#xD;
Afebrile with core temperature ≤ 37.8°C, without use of antipyretics (oral ≤ 37.2°C)&#xD;
Oxygen saturation ≥ 95% on room air without support or a return to pre-infection status, if pre-infection status was &lt; 95%&#xD;
Pulse rate ≤ 100/min&#xD;
Systolic blood pressure ≥ 90 mm/Hg, without vasopressor use&#xD;
Respiratory rate ≤ 24 beats per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 7</measure>
    <time_frame>Baseline to Day 7</time_frame>
    <description>Summary of area under the curve (AUC) over time for seven-level ordinal scale. Area under the curve (AUC) is calculated using the linear trapezoidal rule. Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities. Time frame is from baseline to day 7. Therefore, maximum and minimum values possible for the AUC Clinical Status Ordinal Scale scores range from 7 to 49.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 14.</measure>
    <time_frame>Baseline to Days 14</time_frame>
    <description>Summary of area under the curve (AUC) over time for seven-level ordinal scale. Area under the curve (AUC) is calculated using the linear trapezoidal rule. Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities. Time frame is from baseline to day 14. Therefore, maximum and minimum values possible for the AUC Clinical Status Ordinal Scale scores range from 14 to 98.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Clinical Status on Seven-level Ordinal Scale Scores</measure>
    <time_frame>Day 14</time_frame>
    <description>Summary of Clinical Outcome on Seven-Level Ordinal Scale through Day 14. Worst post-baseline assessment observed.&#xD;
Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Days on Ventilation</measure>
    <time_frame>56 days</time_frame>
    <description>Total number of days on ventilation for participants who used ventilation, including participants on ventilation at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Ordinal Scale Parameters - Days on Ventilation</measure>
    <time_frame>56 days</time_frame>
    <description>Total number of days on ventilation for participations who used ventilation, including participants on ventilation at baseline. Better and worse outcome groups defined based on the Seven-Level Ordinal Scale scores, &quot;&lt;= 4 Seven-Level Ordinal Scale Score&quot; is better; &quot;&gt; 4 Seven-Level Ordinal Scale Score&quot; is worse group.&#xD;
Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Days in ICU</measure>
    <time_frame>56 days</time_frame>
    <description>Total number of days in intensive care (ICU) for participants who admitted to the ICU, including participants in ICU at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Ordinal Scale Parameters - Days in ICU</measure>
    <time_frame>56 days</time_frame>
    <description>Total number of days in intensive care for participants who admitted to ICU, including participants in ICU at baseline. Better and worse outcome groups defined based on the Seven-Level Ordinal Scale scores, &quot;&lt;= 4 Seven-Level Ordinal Scale Score&quot; is better; &quot;&gt; 4 Seven-Level Ordinal Scale Score&quot; is worse group.&#xD;
Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days to Resumption of Usual Activities</measure>
    <time_frame>Day 56</time_frame>
    <description>Number of days until resumption of usual activities by treatment group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All Cause and Attributable Mortality at Day 14</measure>
    <time_frame>Day 14</time_frame>
    <description>Number of patients experiencing all-cause and attributable mortality rates at Day 14. Attributable mortality was derived from the Complication of Influenza eCRF; all-cause mortality was derived from Complication of Influenza, Seven-Level Ordinal Scale, AE and Study Completion eCRFs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All Cause and Attributable Mortality by Day 28</measure>
    <time_frame>Day 28</time_frame>
    <description>Number of patients experiencing all-cause and attributable mortality by Day 28. Attributable mortality was derived from the Complication of Influenza eCRF; all-cause mortality was derived from Complication of Influenza, Seven-Level Ordinal Scale, AE and Study Completion eCRFs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All Cause and Attributable Mortality Day 56</measure>
    <time_frame>Day 56</time_frame>
    <description>Number of patients experiencing all-cause and attributable mortality by Day 56. Attributable mortality was derived from the Complication of Influenza eCRF; all-cause mortality was derived from Complication of Influenza, Seven-Level Ordinal Scale, AE and Study Completion eCRFs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Resource Utilization. Days in Hospital and/or ICU</measure>
    <time_frame>Day 56</time_frame>
    <description>Total number of days in hospital and/or ICU from admission to discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Ordinal Scale Parameters - Days in Hospital/ICU</measure>
    <time_frame>56 days</time_frame>
    <description>Total number of days in hospital or intensive care for participations who were admitted to Hospital/ICU, including participants in Hospital/ICU at baseline. Better and worse outcome groups defined based on the Seven-Level Ordinal Scale scores, &quot;&lt;= 4 Seven-Level Ordinal Scale Score&quot; is better; &quot;&gt; 4 Seven-Level Ordinal Scale Score&quot; is worse group.&#xD;
Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Rehospitalization Due to Relapse</measure>
    <time_frame>Day 56</time_frame>
    <description>Number of participants with rehospitalization due to influenza A relapse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Influenza-related Complications</measure>
    <time_frame>Day 56</time_frame>
    <description>Summary of influenza symptom complications, including baseline and incident complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Maximum Concentration (Cmax) of VIS410 in Participant's Serum</measure>
    <time_frame>Baseline, end of infusion, Day 5, Day 14, Day 28, Day 56</time_frame>
    <description>Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by maximum concentration (Cmax) of VIS410 in participant's serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Area Under the Concentration/Time Curve of VIS410 in Participant's Serum</measure>
    <time_frame>Baseline, end of infusion, Day 5, Day 14, Day 28, Day 56</time_frame>
    <description>Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the area under the concentration/time curve from 0 to infinity (AUC0-inf) of VIS410 in participant's serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Clearance Rate (Cl) of VIS410 in Participant's Serum</measure>
    <time_frame>PK samples were collected on days 1, 5, 14, 28 and 56.</time_frame>
    <description>Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the clearance rate (Cl) of VIS410 in participant's serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Half-life of VIS410 in Participant's Serum</measure>
    <time_frame>PK samples were collected on days 1, 5, 14, 28 and 56.</time_frame>
    <description>Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the half-life (t1/2) of VIS410 in participant's serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-VIS410 Antibody Testing</measure>
    <time_frame>From anti-VIS410 antibody samples collected on days 28 and 56.</time_frame>
    <description>Summary of the maximum fold increase for anti-VIS410 antibody testing for VIS410 groups and placebo.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Influenza A</condition>
  <arm_group>
    <arm_group_label>VIS410 low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intravenous infusion of fixed low dose of VIS410 in addition to oseltamivir</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VIS410 high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intravenous infusion of fixed high dose of VIS410 in addition to oseltamivir</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low dose of VIS410</intervention_name>
    <description>Single intravenous infusion of fixed low dose of VIS410 in addition to oseltamivir</description>
    <arm_group_label>VIS410 low dose</arm_group_label>
    <other_name>oseltamivir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High dose of VIS410</intervention_name>
    <description>Single intravenous infusion of fixed high dose of VIS410 in addition to oseltamivir</description>
    <arm_group_label>VIS410 high dose</arm_group_label>
    <other_name>oseltamivir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>oseltamivir</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects aged ≥ 18 years.&#xD;
&#xD;
          -  Test positive for influenza A by rapid antigen test or with another commercially&#xD;
             available test on an adequate nasopharyngeal specimen in accordance with the&#xD;
             manufacturer's instructions, or an acceptable local test, including PCR (Polymerase&#xD;
             chain reaction), FIA (Fluorescent immunoassay), or ELISA&#xD;
&#xD;
          -  Onset of influenza symptoms no more than 5 days before VIS410/placebo infusion;&#xD;
             symptoms may include cough, dyspnea, sore throat, fever, myalgias, headache, nasal&#xD;
             symptoms (rhinorrhea, congestion), fatigue, diarrhea, anorexia, nausea, and vomiting.&#xD;
&#xD;
          -  Requirement for oxygen support including any positive pressure ventilation&#xD;
&#xD;
          -  Women of childbearing potential must have a negative pregnancy test within 2 days&#xD;
             prior to VIS410/placebo infusion.&#xD;
&#xD;
          -  Women should fulfill one of the following criteria:&#xD;
&#xD;
               -  Post-menopausal; either amenorrhea ≥ 12 months or follicle stimulating hormone &gt;&#xD;
                  40 mIU/mL as documented in their medical history&#xD;
&#xD;
               -  Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation&#xD;
&#xD;
               -  Women of childbearing potential participating in heterosexual sexual relations&#xD;
                  must be willing to use adequate contraception from screening until 60 days post&#xD;
                  VIS410/placebo infusion.&#xD;
&#xD;
          -  Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects&#xD;
             who have a female partner of childbearing potential must use an effective birth&#xD;
             control method from screening until 60 days post VIS410/placebo infusion.&#xD;
&#xD;
          -  Subject, or a legally acceptable representative (LAR), is able to understand the&#xD;
             purpose and risks of the study and willing to give voluntary written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected intolerance or hypersensitivity to VIS410, oseltamivir,&#xD;
             pretreatment medications (diphenhydramine, or to both ibuprofen and acetylsalicylic&#xD;
             acid [ASA]), or closely related compounds (eg, other monoclonal antibodies)&#xD;
&#xD;
          -  Subjects who have received VIS410 in the past&#xD;
&#xD;
          -  History of receiving monoclonal antibody products (including VIS410) within 3 months&#xD;
             prior to VIS410/placebo dosing or planned administration during the study period&#xD;
&#xD;
          -  Subjects who have taken more than 6 doses of an approved antiviral therapy for&#xD;
             influenza within the prior 96 hours (eg, oral oseltamivir, inhaled zanamivir, IV&#xD;
             peramivir, or oral ribavirin) between onset of symptoms and VIS410/placebo dosing&#xD;
&#xD;
          -  Subjects with known co-infection with influenza B or other viral respiratory&#xD;
             infections (e.g., respiratory syncytial virus, parainfluenza viruses, respiratory&#xD;
             adenoviruses)&#xD;
&#xD;
          -  Subjects with lung transplant or history of severe chronic lung disease, including&#xD;
             cystic fibrosis or any condition requiring home oxygen therapy&#xD;
&#xD;
          -  Subjects on extracorporeal membrane oxygenation (ECMO) at time of randomization&#xD;
&#xD;
          -  Subjects with end stage renal disease who are not undergoing hemodialysis&#xD;
&#xD;
          -  Subjects with active graft-vs-host disease, hematopoietic stem cell transplant within&#xD;
             the previous 90 days, or human immunodeficiency virus infection with a CD4 cell count&#xD;
             of less than 200 per cubic millimeter&#xD;
&#xD;
          -  Hospitalization for &gt; 48 hours prior to randomization&#xD;
&#xD;
          -  High probability of mortality within 48 hours of randomization as determined by the&#xD;
             Investigator&#xD;
&#xD;
          -  Subjects weighing less than 45 kg&#xD;
&#xD;
          -  Enrollment in any other investigational drug or device study, any disease or vaccine&#xD;
             study within 30 days prior to Day 1 or within 5 half-lives of the investigational&#xD;
             compound, whichever is longer&#xD;
&#xD;
          -  Known or suspected alcohol or drug abuse, that is, abuse of a level that would&#xD;
             compromise the safety or cooperation of the subject in the opinion of the Investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Oldach, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Visterra, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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      <address>
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  <location>
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  <location>
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  <location>
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  <location>
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      <address>
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      <address>
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      <address>
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  <location>
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      <address>
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      <address>
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      <address>
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  <location>
    <facility>
      <name>Visterra</name>
      <address>
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  <location>
    <facility>
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      <address>
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  <location>
    <facility>
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  <location>
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      <name>Visterra</name>
      <address>
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  <location>
    <facility>
      <name>Visterra</name>
      <address>
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  <location>
    <facility>
      <name>Visterra</name>
      <address>
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  <location>
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      <name>Visterra</name>
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  <location>
    <facility>
      <name>Visterra</name>
      <address>
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  <location>
    <facility>
      <name>Visterra</name>
      <address>
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  <location>
    <facility>
      <name>Visterra</name>
      <address>
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  <location>
    <facility>
      <name>Visterra</name>
      <address>
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  <location>
    <facility>
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      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Granada</city>
        <zip>18016</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Terrassa</city>
        <zip>08221</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Bangkok</city>
        <zip>10110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Khon Kaen</city>
        <zip>40002</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Mueang Nonthaburi</city>
        <zip>11000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Ankara</city>
        <zip>06230</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Trabzon</city>
        <zip>61080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Ivano-Frankivs'k</city>
        <zip>76008</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Kyiv</city>
        <zip>01133</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Kyiv</city>
        <zip>04112</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Odesa</city>
        <zip>65023</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Poltava</city>
        <zip>36038</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Sumy</city>
        <zip>40021</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visterra</name>
      <address>
        <city>Zhytomyr</city>
        <zip>10002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belarus</country>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Georgia</country>
    <country>Latvia</country>
    <country>Malaysia</country>
    <country>New Zealand</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Singapore</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Thailand</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>June 13, 2022</results_first_submitted>
  <results_first_submitted_qc>December 9, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 28, 2022</results_first_posted>
  <last_update_submitted>December 9, 2022</last_update_submitted>
  <last_update_submitted_qc>December 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oseltamivir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03040141/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 17, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03040141/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Approximately 120 participants were planned however, a total of 89 subjects were randomized to treatment. 73 participants completed the trial. There were study discontinuations for death, consent withdrawn and participants who were enrolled, but did not receive study drug.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>VIS410 High Dose</title>
          <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
        </group>
        <group group_id="P2">
          <title>VIS410 Low Dose</title>
          <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject discharged to nursing home, not able to attend visits</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject did not receive study drug or was not confirmed Influenza A positive</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Modified Intent to treat (MITT) population. All subjects of the safety population that have an assessment of O2 support after randomization and are confirmed influenza A positive. Subjects will be analyzed based on the treatment to which they were randomized, irrespective of what they actually received. This population was selected for the analysis of the primary endpoint to maintain the benefits of randomization and avoid the bias associated with the non-random loss of the participants</population>
      <group_list>
        <group group_id="B1">
          <title>VIS410 High Dose</title>
          <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
        </group>
        <group group_id="B2">
          <title>VIS410 Low Dose</title>
          <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="29"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="28"/>
            <count group_id="B4" value="85"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Age (years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60" spread="19.00"/>
                    <measurement group_id="B2" value="66.2" spread="13.94"/>
                    <measurement group_id="B3" value="57.5" spread="22.41"/>
                    <measurement group_id="B4" value="61.2" spread="18.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="00"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Singapore</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaysia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belarus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thailand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latvia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Africa</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Georgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serbia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Estonia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index (kg/m^2)</title>
          <units>Kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.2" spread="6.48"/>
                    <measurement group_id="B2" value="28.4" spread="7.93"/>
                    <measurement group_id="B3" value="29.2" spread="6.3"/>
                    <measurement group_id="B4" value="28.6" spread="6.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinical Status of Participants on Day 7</title>
        <description>Evaluate the effect of 2 dose levels of VIS410 + oseltamivir on clinical status using a seven-level ordinal scale. Comparison between treatment groups and between all VIS410 recipients versus placebo were assessed.</description>
        <time_frame>7 days</time_frame>
        <population>Modified Intent to treat (MITT) population. All participants of the safety population that have an assessment of O2 support after randomization and are confirmed influenza A positive. Participants will be analyzed based on the treatment to which they were randomized, irrespective of what they actually received. This population was selected for the analysis of the primary endpoint to maintain the benefits of randomization and avoid the bias associated with the non-random loss of the participants</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Status of Participants on Day 7</title>
          <description>Evaluate the effect of 2 dose levels of VIS410 + oseltamivir on clinical status using a seven-level ordinal scale. Comparison between treatment groups and between all VIS410 recipients versus placebo were assessed.</description>
          <population>Modified Intent to treat (MITT) population. All participants of the safety population that have an assessment of O2 support after randomization and are confirmed influenza A positive. Participants will be analyzed based on the treatment to which they were randomized, irrespective of what they actually received. This population was selected for the analysis of the primary endpoint to maintain the benefits of randomization and avoid the bias associated with the non-random loss of the participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Death</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ICU stay with mechanical ventilation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ICU stay without mechanical ventilation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-ICU hospitalization with supplemental oxygen</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-ICU hospitalization without supplemental oxygen</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Discharge with partial resumption of normal activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Discharge with full resumption of normal activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.181</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.03</ci_lower_limit>
            <ci_upper_limit>13.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.073</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>12.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.037</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.08</ci_lower_limit>
            <ci_upper_limit>11.48</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.814</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.40</ci_lower_limit>
            <ci_upper_limit>3.25</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Number of Participants With Adverse Events and Serious Adverse Events Following Administration of VIS410</title>
        <description>Safety and tolerability of 2 dose levels of a single intravenous (IV) dose of VIS410 when administered in combination with oseltamivir in hospitalized participants with influenza A infection. Data presents the count of participants who experienced an adverse event (AE) or serious treatment emergent adverse events (TEAE).</description>
        <time_frame>56 days</time_frame>
        <population>Safety Population: Included all ITT participants (participants who randomized to treatment) who received IV study drug. Participants were grouped according to the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Adverse Events and Serious Adverse Events Following Administration of VIS410</title>
          <description>Safety and tolerability of 2 dose levels of a single intravenous (IV) dose of VIS410 when administered in combination with oseltamivir in hospitalized participants with influenza A infection. Data presents the count of participants who experienced an adverse event (AE) or serious treatment emergent adverse events (TEAE).</description>
          <population>Safety Population: Included all ITT participants (participants who randomized to treatment) who received IV study drug. Participants were grouped according to the actual treatment received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="38"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with at least one serious treatment emergent adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Cessation of Oxygen Support Compared to Oseltamivir Alone Among Patients Requiring Supplemental Oxygen Therapy With Baseline Room Air &lt;= 92%</title>
        <description>Time to cessation of O2 support in patients with supplemental oxygen with baseline room air &lt;= 92%. Patients with treatment resulting in a stable SpO2 by pulse oximetry. Stable SpO2 is defined as two consecutive SpO2 values of &gt;92% on room air that are at least 8 hours apart.</description>
        <time_frame>Baseline to Day 56</time_frame>
        <population>Modified intent to treat population (MITT), number of participants who had cessation of oxygen support.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Cessation of Oxygen Support Compared to Oseltamivir Alone Among Patients Requiring Supplemental Oxygen Therapy With Baseline Room Air &lt;= 92%</title>
          <description>Time to cessation of O2 support in patients with supplemental oxygen with baseline room air &lt;= 92%. Patients with treatment resulting in a stable SpO2 by pulse oximetry. Stable SpO2 is defined as two consecutive SpO2 values of &gt;92% on room air that are at least 8 hours apart.</description>
          <population>Modified intent to treat population (MITT), number of participants who had cessation of oxygen support.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="33"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.5" lower_limit="45.5" upper_limit="138.7"/>
                    <measurement group_id="O2" value="101.3" lower_limit="26.9" upper_limit="114.6"/>
                    <measurement group_id="O3" value="97.3" lower_limit="45.5" upper_limit="124.7"/>
                    <measurement group_id="O4" value="79.0" lower_limit="41.7" upper_limit="103.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.748</p_value>
            <p_value_desc>p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level. The goal will be used to assess the strength of evidence to select the endpoints for a Phase 3 trial.</p_value_desc>
            <method>Chi-squared</method>
            <method_desc>All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The VIS410 low-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.940</p_value>
            <p_value_desc>p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.</p_value_desc>
            <method>Chi-squared</method>
            <method_desc>All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The total VIS410 high-dose group (high-dose + low-dose) was compared against the placebo group. The null hypothesis was defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.902</p_value>
            <p_value_desc>p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.</p_value_desc>
            <method>Chi-squared</method>
            <method_desc>All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The VIS410 high-dose group was compared against the VIS410 low-dose group. The null hypothesis was defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.283</p_value>
            <p_value_desc>p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.</p_value_desc>
            <method>Chi-squared</method>
            <method_desc>All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Cessation of Oxygen Support for Any Patient Requiring Supplemental Oxygen Therapy</title>
        <description>Time to cessation of oxygen support in all patients with supplemental oxygen (regardless of oxygen saturation).</description>
        <time_frame>Baseline to Day 56</time_frame>
        <population>Modified intent to treat population (MITT), number of participants who had cessation of oxygen support. NE = not estimable.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Cessation of Oxygen Support for Any Patient Requiring Supplemental Oxygen Therapy</title>
          <description>Time to cessation of oxygen support in all patients with supplemental oxygen (regardless of oxygen saturation).</description>
          <population>Modified intent to treat population (MITT), number of participants who had cessation of oxygen support. NE = not estimable.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119.2" lower_limit="82.3" upper_limit="257.0"/>
                    <measurement group_id="O2" value="129.7" lower_limit="99.3" upper_limit="NA">Data are not estimable due to the insufficient number of participants with events for two main reasons. First measured baseline room air oxygen saturation was &gt;92% in some subjects and in others the subject was already on supplemental oxygen and a measurement on room air at baseline was not obtained.</measurement>
                    <measurement group_id="O3" value="124.7" lower_limit="83.6" upper_limit="NA">Data are not estimable due to the insufficient number of participants with events for two main reasons. First measured baseline room air oxygen saturation was &gt;92% in some subjects and in others the subject was already on supplemental oxygen and a measurement on room air at baseline was not obtained.</measurement>
                    <measurement group_id="O4" value="112.2" lower_limit="74.2" upper_limit="NA">Data are not estimable due to the insufficient number of participants with events for two main reasons. First measured baseline room air oxygen saturation was &gt;92% in some subjects and in others the subject was already on supplemental oxygen and a measurement on room air at baseline was not obtained.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.919</p_value>
            <p_value_desc>p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.</p_value_desc>
            <method>Chi-squared</method>
            <method_desc>All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The VIS410 low-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.900</p_value>
            <p_value_desc>p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.</p_value_desc>
            <method>Chi-squared</method>
            <method_desc>All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The combined VIS410 high- and low-dose groups was compared against the placebo group. The null hypothesis was defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.990</p_value>
            <p_value_desc>p-value is not adjusted for multiple comparisons</p_value_desc>
            <method>Chi-squared</method>
            <method_desc>All statistical comparisons were performed using 2-sided tests at the 0.05 significance level</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The VIS410 high-dose group was compared against the VIS410 low-dose group. The null hypothesis was defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.521</p_value>
            <p_value_desc>The p-value is not adjusted for multiple comparisons.</p_value_desc>
            <method>Chi-squared</method>
            <method_desc>All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Viral Titer in Upper Respiratory Samples by qRT-PCR</title>
        <description>The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in peak viral load by qRT-PCR from nasopharyngeal swabs through Day 14</description>
        <time_frame>Day 14</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment. All efficacy analyses including the primary efficacy analyses were performed in the MITT population</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Viral Titer in Upper Respiratory Samples by qRT-PCR</title>
          <description>The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in peak viral load by qRT-PCR from nasopharyngeal swabs through Day 14</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment. All efficacy analyses including the primary efficacy analyses were performed in the MITT population</population>
          <units>log10 virus particles/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.479" spread="1.3860"/>
                    <measurement group_id="O2" value="6.378" spread="1.1320"/>
                    <measurement group_id="O3" value="6.429" spread="1.2544"/>
                    <measurement group_id="O4" value="6.169" spread="1.2489"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.360</p_value>
            <p_value_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Viral Nasopharyngeal AUC</title>
        <description>The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in nasopharyngeal qRT-PCR area under the viral load-time curve (AUC) from baseline to Day 5.</description>
        <time_frame>Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Viral Nasopharyngeal AUC</title>
          <description>The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in nasopharyngeal qRT-PCR area under the viral load-time curve (AUC) from baseline to Day 5.</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>Day*Log10 virus particles/ mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.329" spread="6.7272"/>
                    <measurement group_id="O2" value="15.999" spread="4.9232"/>
                    <measurement group_id="O3" value="17.164" spread="5.9559"/>
                    <measurement group_id="O4" value="17.727" spread="5.9824"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.735</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.259</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.644</p_value>
            <p_value_desc>The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.146</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Viral Load-Time Curve (VL AUC) Based on qRT-PCR From Nasopharyngeal Swabs Through Day 7</title>
        <description>The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in nasopharyngeal qRT-PCR area under the viral load-time curve (AUC) from baseline to Day 7.</description>
        <time_frame>Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5, Day 7</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>Total VIS410</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Viral Load-Time Curve (VL AUC) Based on qRT-PCR From Nasopharyngeal Swabs Through Day 7</title>
          <description>The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in nasopharyngeal qRT-PCR area under the viral load-time curve (AUC) from baseline to Day 7.</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>Day*vp/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.490" spread="9.0440"/>
                    <measurement group_id="O2" value="22.394" spread="7.9006"/>
                    <measurement group_id="O3" value="23.942" spread="8.5550"/>
                    <measurement group_id="O4" value="24.337" spread="8.8837"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.624</p_value>
            <p_value_desc>The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.399</p_value>
            <p_value_desc>The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.</p_value_desc>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.837</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.183</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Viral Load-Time Curve (VL AUC) Based on qRT-PCR From Nasopharyngeal Swabs Through Day 14</title>
        <description>The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in nasopharyngeal qRT-PCR area under the viral load-time curve (AUC) from baseline to Day 14.</description>
        <time_frame>Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5, Day 7, Day 14</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>Total VIS410</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Viral Load-Time Curve (VL AUC) Based on qRT-PCR From Nasopharyngeal Swabs Through Day 14</title>
          <description>The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in nasopharyngeal qRT-PCR area under the viral load-time curve (AUC) from baseline to Day 14.</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>Day*vp/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.356" spread="17.6513"/>
                    <measurement group_id="O2" value="35.172" spread="18.6217"/>
                    <measurement group_id="O3" value="36.264" spread="17.9980"/>
                    <measurement group_id="O4" value="36.668" spread="17.2015"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference</non_inferiority_desc>
            <p_value>0.880</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference</non_inferiority_desc>
            <p_value>0.778</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.940</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.662</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to Resolution of Viral Load by Treatment Arm by qRT-PCR - From End of Infusion</title>
        <description>Number of days from the end of infusion until virus is no longer detectable (at or below the limit of detection) with no samples following that are greater than the BLQ through the Day 14 (quantitative reverse-transcription polymerase chain reaction - qRT-PCR)</description>
        <time_frame>14 days</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>Total VIS410</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to Resolution of Viral Load by Treatment Arm by qRT-PCR - From End of Infusion</title>
          <description>Number of days from the end of infusion until virus is no longer detectable (at or below the limit of detection) with no samples following that are greater than the BLQ through the Day 14 (quantitative reverse-transcription polymerase chain reaction - qRT-PCR)</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.5" lower_limit="8.0" upper_limit="14.7"/>
                    <measurement group_id="O2" value="12.7" lower_limit="5.9" upper_limit="13.7"/>
                    <measurement group_id="O3" value="12.7" lower_limit="10.7" upper_limit="13.7"/>
                    <measurement group_id="O4" value="11.9" lower_limit="6.5" upper_limit="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.640</p_value>
            <method>Chi-squared</method>
            <method_desc>A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.775</p_value>
            <method>Chi-squared</method>
            <method_desc>A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.701</p_value>
            <method>Chi-squared</method>
            <method_desc>A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.638</p_value>
            <method>Chi-squared</method>
            <method_desc>A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by qRT-PCR</title>
        <description>Number of participants in whom peak viral load is observed post-baseline based on quantitative reverse-transcription polymerase chain reaction (qRT-PCR). Post-baseline was considered the day 3 sample or later.</description>
        <time_frame>14 days</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by qRT-PCR</title>
          <description>Number of participants in whom peak viral load is observed post-baseline based on quantitative reverse-transcription polymerase chain reaction (qRT-PCR). Post-baseline was considered the day 3 sample or later.</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.127</p_value>
            <method>Regression, Logistic</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>1.000</p_value>
            <method>Regression, Logistic</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.458</p_value>
            <method>Regression, Logistic</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.127</p_value>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Peak Viral Load by TCID50</title>
        <description>Peak viral load based on TCID50 from nasopharyngeal swabs</description>
        <time_frame>Day 7</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Viral Load by TCID50</title>
          <description>Peak viral load based on TCID50 from nasopharyngeal swabs</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>log10 TCID50/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.047" spread="2.1651"/>
                    <measurement group_id="O2" value="2.714" spread="1.7415"/>
                    <measurement group_id="O3" value="2.881" spread="1.9534"/>
                    <measurement group_id="O4" value="2.604" spread="2.0278"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.371</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.735</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.476</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.581</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by TCID50</title>
        <description>Number of participants in whom peak viral load occurred post-baseline measured by TCID50. Post-baseline was considered the day 3 sample or later.</description>
        <time_frame>56 days</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by TCID50</title>
          <description>Number of participants in whom peak viral load occurred post-baseline measured by TCID50. Post-baseline was considered the day 3 sample or later.</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.980</p_value>
            <method>Regression, Logistic</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.955</p_value>
            <method>Regression, Logistic</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.955</p_value>
            <method>Regression, Logistic</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.955</p_value>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Viral Nasopharyngeal AUC by TCID50</title>
        <description>The area under the viral load-time curve (AUC) for VIS410 + oseltamivir and oseltamivir alone treatment groups from baseline to Day 5 measured by TCID50 from nasopharyngeal swabs.</description>
        <time_frame>5 days</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Viral Nasopharyngeal AUC by TCID50</title>
          <description>The area under the viral load-time curve (AUC) for VIS410 + oseltamivir and oseltamivir alone treatment groups from baseline to Day 5 measured by TCID50 from nasopharyngeal swabs.</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>Day*TCID50 log10/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.826" spread="4.2581"/>
                    <measurement group_id="O2" value="2.823" spread="2.4121"/>
                    <measurement group_id="O3" value="3.324" spread="3.4649"/>
                    <measurement group_id="O4" value="3.519" spread="3.5317"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.695</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.542</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.899</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.321</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Viral Nasopharyngeal AUC by TCID50</title>
        <description>The area under the viral load-time curve (AUC) for VIS410 + oseltamivir and oseltamivir alone treatment groups from baseline to Day 7 measured by TCID50 from nasopharyngeal swabs.</description>
        <time_frame>7 days</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Viral Nasopharyngeal AUC by TCID50</title>
          <description>The area under the viral load-time curve (AUC) for VIS410 + oseltamivir and oseltamivir alone treatment groups from baseline to Day 7 measured by TCID50 from nasopharyngeal swabs.</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>Day*TCID50 log10/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.140" spread="5.2238"/>
                    <measurement group_id="O2" value="2.886" spread="2.5260"/>
                    <measurement group_id="O3" value="3.513" spread="4.1131"/>
                    <measurement group_id="O4" value="3.711" spread="4.2207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.663</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.540</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.918</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.294</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Negative Viral Cultures by Study Day</title>
        <description>Number of participants negative for viral titer by study day determined by TCID50 on nominal days 3, 5, 7</description>
        <time_frame>Nominal days 3, 5, 7</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment, who also had a positive baseline viral culture based on TCID50.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Negative Viral Cultures by Study Day</title>
          <description>Number of participants negative for viral titer by study day determined by TCID50 on nominal days 3, 5, 7</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment, who also had a positive baseline viral culture based on TCID50.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with negative viral cultures by Day 3.</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="57"/>
                    <count group_id="O4" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="47"/>
                    <measurement group_id="O4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with negative viral cultures by Day 5.</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="54"/>
                    <count group_id="O4" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="51"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with negative viral cultures by Day 7.</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="55"/>
                    <count group_id="O4" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="55"/>
                    <measurement group_id="O4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From End of Infusion</title>
        <description>Number of days from the end of infusion until virus is no longer detectable (at or below the limit of detection) with no samples following that are greater than the BLQ through the Day 7 (TCID50)</description>
        <time_frame>7 Days</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by TCID50 in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment, who also had a positive baseline viral culture based on TCID50.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From End of Infusion</title>
          <description>Number of days from the end of infusion until virus is no longer detectable (at or below the limit of detection) with no samples following that are greater than the BLQ through the Day 7 (TCID50)</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by TCID50 in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment, who also had a positive baseline viral culture based on TCID50.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="0.6" upper_limit="1.9"/>
                    <measurement group_id="O2" value="1.7" lower_limit="1.5" upper_limit="1.8"/>
                    <measurement group_id="O3" value="1.7" lower_limit="1.6" upper_limit="1.7"/>
                    <measurement group_id="O4" value="1.8" lower_limit="0.0" upper_limit="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.250</p_value>
            <method>Chi-squared</method>
            <method_desc>Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.133</p_value>
            <method>Chi-squared</method>
            <method_desc>Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.177</p_value>
            <method>Chi-squared</method>
            <method_desc>Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.360</p_value>
            <method>Chi-squared</method>
            <method_desc>Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From Onset of Symptoms</title>
        <description>Number of days from the onset of symptoms until virus is no longer detectable (at or below the limit of detection) with no samples following that are greater than the BLQ through the Day 7 (TCID50)</description>
        <time_frame>7 Days</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by TCID50 in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment, who also had a positive baseline viral culture based on TCID50.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From Onset of Symptoms</title>
          <description>Number of days from the onset of symptoms until virus is no longer detectable (at or below the limit of detection) with no samples following that are greater than the BLQ through the Day 7 (TCID50)</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by TCID50 in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment, who also had a positive baseline viral culture based on TCID50.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="54"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" lower_limit="3.6" upper_limit="5.3"/>
                    <measurement group_id="O2" value="4.8" lower_limit="3.9" upper_limit="5.1"/>
                    <measurement group_id="O3" value="4.8" lower_limit="4.1" upper_limit="4.9"/>
                    <measurement group_id="O4" value="4.4" lower_limit="4.0" upper_limit="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.636</p_value>
            <method>Chi-squared</method>
            <method_desc>Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.446</p_value>
            <method>Chi-squared</method>
            <method_desc>Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.530</p_value>
            <method>Chi-squared</method>
            <method_desc>Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.463</p_value>
            <method>Chi-squared</method>
            <method_desc>Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Clinical Response (4 Out of 5 Vital Signs)</title>
        <description>Median time to clinical response defined by resolution of at least 4 of 5 vital signs:&#xD;
Afebrile with core temperature ≤ 37.8°C, without use of antipyretics (oral ≤ 37.2°C)&#xD;
Oxygen saturation ≥ 95% on room air without support or a return to preinfection status, if pre-infection status was &lt; 95%&#xD;
Pulse rate ≤ 100/min&#xD;
Systolic blood pressure ≥ 90 mm/Hg, without vasopressor use&#xD;
Respiratory rate ≤ 24 beats per minute</description>
        <time_frame>Day 56</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Clinical Response (4 Out of 5 Vital Signs)</title>
          <description>Median time to clinical response defined by resolution of at least 4 of 5 vital signs:&#xD;
Afebrile with core temperature ≤ 37.8°C, without use of antipyretics (oral ≤ 37.2°C)&#xD;
Oxygen saturation ≥ 95% on room air without support or a return to preinfection status, if pre-infection status was &lt; 95%&#xD;
Pulse rate ≤ 100/min&#xD;
Systolic blood pressure ≥ 90 mm/Hg, without vasopressor use&#xD;
Respiratory rate ≤ 24 beats per minute</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="2.2" upper_limit="21.9"/>
                    <measurement group_id="O2" value="2.6" lower_limit="2.2" upper_limit="24.0"/>
                    <measurement group_id="O3" value="2.6" lower_limit="2.2" upper_limit="21.9"/>
                    <measurement group_id="O4" value="2.8" lower_limit="2.2" upper_limit="44.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.152</p_value>
            <method>Chi-squared</method>
            <method_desc>Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.176</p_value>
            <method>Chi-squared</method>
            <method_desc>Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.157</p_value>
            <method>Chi-squared</method>
            <method_desc>Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.844</p_value>
            <method>Chi-squared</method>
            <method_desc>Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Complete Clinical Response (Resolution of All Vital Signs)</title>
        <description>Median time to clinical response defined by resolution of at all 5 vital signs:&#xD;
Afebrile with core temperature ≤ 37.8°C, without use of antipyretics (oral ≤ 37.2°C)&#xD;
Oxygen saturation ≥ 95% on room air without support or a return to pre-infection status, if pre-infection status was &lt; 95%&#xD;
Pulse rate ≤ 100/min&#xD;
Systolic blood pressure ≥ 90 mm/Hg, without vasopressor use&#xD;
Respiratory rate ≤ 24 beats per minute</description>
        <time_frame>Day 56</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Complete Clinical Response (Resolution of All Vital Signs)</title>
          <description>Median time to clinical response defined by resolution of at all 5 vital signs:&#xD;
Afebrile with core temperature ≤ 37.8°C, without use of antipyretics (oral ≤ 37.2°C)&#xD;
Oxygen saturation ≥ 95% on room air without support or a return to pre-infection status, if pre-infection status was &lt; 95%&#xD;
Pulse rate ≤ 100/min&#xD;
Systolic blood pressure ≥ 90 mm/Hg, without vasopressor use&#xD;
Respiratory rate ≤ 24 beats per minute</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103.0" lower_limit="45.4" upper_limit="170.6"/>
                    <measurement group_id="O2" value="114.6" lower_limit="47.5" upper_limit="166.1"/>
                    <measurement group_id="O3" value="103.0" lower_limit="47.5" upper_limit="170.6"/>
                    <measurement group_id="O4" value="99.8" lower_limit="63.0" upper_limit="168.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.531</p_value>
            <method>Chi-squared</method>
            <method_desc>Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.582</p_value>
            <method>Chi-squared</method>
            <method_desc>Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.550</p_value>
            <method>Chi-squared</method>
            <method_desc>Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.840</p_value>
            <method>Chi-squared</method>
            <method_desc>P-value determined based on Cox proportional hazards model Wald Chi-Square Statistic.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 7</title>
        <description>Summary of area under the curve (AUC) over time for seven-level ordinal scale. Area under the curve (AUC) is calculated using the linear trapezoidal rule. Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities. Time frame is from baseline to day 7. Therefore, maximum and minimum values possible for the AUC Clinical Status Ordinal Scale scores range from 7 to 49.</description>
        <time_frame>Baseline to Day 7</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 7</title>
          <description>Summary of area under the curve (AUC) over time for seven-level ordinal scale. Area under the curve (AUC) is calculated using the linear trapezoidal rule. Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities. Time frame is from baseline to day 7. Therefore, maximum and minimum values possible for the AUC Clinical Status Ordinal Scale scores range from 7 to 49.</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment</population>
          <units>day*units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.6" spread="5.55"/>
                    <measurement group_id="O2" value="22.4" spread="7.47"/>
                    <measurement group_id="O3" value="23.0" spread="6.53"/>
                    <measurement group_id="O4" value="21.4" spread="4.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.3534</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.7839</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.4893</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.5101</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 14.</title>
        <description>Summary of area under the curve (AUC) over time for seven-level ordinal scale. Area under the curve (AUC) is calculated using the linear trapezoidal rule. Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities. Time frame is from baseline to day 14. Therefore, maximum and minimum values possible for the AUC Clinical Status Ordinal Scale scores range from 14 to 98.</description>
        <time_frame>Baseline to Days 14</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 14.</title>
          <description>Summary of area under the curve (AUC) over time for seven-level ordinal scale. Area under the curve (AUC) is calculated using the linear trapezoidal rule. Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities. Time frame is from baseline to day 14. Therefore, maximum and minimum values possible for the AUC Clinical Status Ordinal Scale scores range from 14 to 98.</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment</population>
          <units>day*units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.3" spread="15.21"/>
                    <measurement group_id="O2" value="38.2" spread="18.73"/>
                    <measurement group_id="O3" value="39.3" spread="16.91"/>
                    <measurement group_id="O4" value="35.8" spread="12.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.5436</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.8215</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.6319</p_value>
            <method>ANCOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.7011</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of Clinical Status on Seven-level Ordinal Scale Scores</title>
        <description>Summary of Clinical Outcome on Seven-Level Ordinal Scale through Day 14. Worst post-baseline assessment observed.&#xD;
Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.</description>
        <time_frame>Day 14</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Clinical Status on Seven-level Ordinal Scale Scores</title>
          <description>Summary of Clinical Outcome on Seven-Level Ordinal Scale through Day 14. Worst post-baseline assessment observed.&#xD;
Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Death</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ICU stay with mechanical ventilation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ICU stay without mechanical ventilation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-ICU hospitalization with supplemental oxygen</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="35"/>
                    <measurement group_id="O4" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-ICU hospitalization without supplemental oxygen</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Discharge with partial resumption of normal activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Discharge with full resumption of normal activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.478</p_value>
            <method>Regression, Logistic</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.468</p_value>
            <method>Regression, Logistic</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.412</p_value>
            <method>Regression, Logistic</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The null hypothesis was defined as no treatment difference.</non_inferiority_desc>
            <p_value>0.982</p_value>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Days on Ventilation</title>
        <description>Total number of days on ventilation for participants who used ventilation, including participants on ventilation at baseline</description>
        <time_frame>56 days</time_frame>
        <population>Participants requiring ventilation from the mITT population. The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Days on Ventilation</title>
          <description>Total number of days on ventilation for participants who used ventilation, including participants on ventilation at baseline</description>
          <population>Participants requiring ventilation from the mITT population. The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="4.55"/>
                    <measurement group_id="O2" value="7.0" spread="5.20"/>
                    <measurement group_id="O3" value="5.9" spread="4.52"/>
                    <measurement group_id="O4" value="11.7" spread="7.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of Ordinal Scale Parameters - Days on Ventilation</title>
        <description>Total number of days on ventilation for participations who used ventilation, including participants on ventilation at baseline. Better and worse outcome groups defined based on the Seven-Level Ordinal Scale scores, &quot;&lt;= 4 Seven-Level Ordinal Scale Score&quot; is better; &quot;&gt; 4 Seven-Level Ordinal Scale Score&quot; is worse group.&#xD;
Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.</description>
        <time_frame>56 days</time_frame>
        <population>Participants requiring ventilation from the mITT population. The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>Total VIS410</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Ordinal Scale Parameters - Days on Ventilation</title>
          <description>Total number of days on ventilation for participations who used ventilation, including participants on ventilation at baseline. Better and worse outcome groups defined based on the Seven-Level Ordinal Scale scores, &quot;&lt;= 4 Seven-Level Ordinal Scale Score&quot; is better; &quot;&gt; 4 Seven-Level Ordinal Scale Score&quot; is worse group.&#xD;
Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.</description>
          <population>Participants requiring ventilation from the mITT population. The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt; 4 Seven-Level Ordinal Scale Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="4.55"/>
                    <measurement group_id="O2" value="7.0" spread="5.2"/>
                    <measurement group_id="O3" value="5.9" spread="4.52"/>
                    <measurement group_id="O4" value="8.0" spread="5.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;= 4 Seven-Level Ordinal Scale Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="19.0" spread="NA">There is only 1 participant analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Days in ICU</title>
        <description>Total number of days in intensive care (ICU) for participants who admitted to the ICU, including participants in ICU at baseline</description>
        <time_frame>56 days</time_frame>
        <population>Participants admitted to the ICU from the mITT population. The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Days in ICU</title>
          <description>Total number of days in intensive care (ICU) for participants who admitted to the ICU, including participants in ICU at baseline</description>
          <population>Participants admitted to the ICU from the mITT population. The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" spread="7.43"/>
                    <measurement group_id="O2" value="6.8" spread="3.71"/>
                    <measurement group_id="O3" value="7.7" spread="5.88"/>
                    <measurement group_id="O4" value="14.0" spread="9.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of Ordinal Scale Parameters - Days in ICU</title>
        <description>Total number of days in intensive care for participants who admitted to ICU, including participants in ICU at baseline. Better and worse outcome groups defined based on the Seven-Level Ordinal Scale scores, &quot;&lt;= 4 Seven-Level Ordinal Scale Score&quot; is better; &quot;&gt; 4 Seven-Level Ordinal Scale Score&quot; is worse group.&#xD;
Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.</description>
        <time_frame>56 days</time_frame>
        <population>Participants requiring ventilation from the mITT population. The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Ordinal Scale Parameters - Days in ICU</title>
          <description>Total number of days in intensive care for participants who admitted to ICU, including participants in ICU at baseline. Better and worse outcome groups defined based on the Seven-Level Ordinal Scale scores, &quot;&lt;= 4 Seven-Level Ordinal Scale Score&quot; is better; &quot;&gt; 4 Seven-Level Ordinal Scale Score&quot; is worse group.&#xD;
Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.</description>
          <population>Participants requiring ventilation from the mITT population. The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt; 4 Seven-Level Ordinal Scale Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" spread="7.43"/>
                    <measurement group_id="O2" value="6.8" spread="3.71"/>
                    <measurement group_id="O3" value="7.7" spread="5.88"/>
                    <measurement group_id="O4" value="10.8" spread="6.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;= 4 Seven-Level Ordinal Scale Score&quot; is better</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="27.0" spread="NA">There is only 1 participant analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days to Resumption of Usual Activities</title>
        <description>Number of days until resumption of usual activities by treatment group</description>
        <time_frame>Day 56</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days to Resumption of Usual Activities</title>
          <description>Number of days until resumption of usual activities by treatment group</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" spread="3.07"/>
                    <measurement group_id="O2" value="10.3" spread="4.10"/>
                    <measurement group_id="O3" value="11.1" spread="3.67"/>
                    <measurement group_id="O4" value="11.5" spread="3.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All Cause and Attributable Mortality at Day 14</title>
        <description>Number of patients experiencing all-cause and attributable mortality rates at Day 14. Attributable mortality was derived from the Complication of Influenza eCRF; all-cause mortality was derived from Complication of Influenza, Seven-Level Ordinal Scale, AE and Study Completion eCRFs</description>
        <time_frame>Day 14</time_frame>
        <population>The safety population included all ITT participants who received IV study drug. Participants were grouped according to the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>All Cause and Attributable Mortality at Day 14</title>
          <description>Number of patients experiencing all-cause and attributable mortality rates at Day 14. Attributable mortality was derived from the Complication of Influenza eCRF; all-cause mortality was derived from Complication of Influenza, Seven-Level Ordinal Scale, AE and Study Completion eCRFs</description>
          <population>The safety population included all ITT participants who received IV study drug. Participants were grouped according to the actual treatment received.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All-cause mortality Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attributable mortality Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All Cause and Attributable Mortality by Day 28</title>
        <description>Number of patients experiencing all-cause and attributable mortality by Day 28. Attributable mortality was derived from the Complication of Influenza eCRF; all-cause mortality was derived from Complication of Influenza, Seven-Level Ordinal Scale, AE and Study Completion eCRFs</description>
        <time_frame>Day 28</time_frame>
        <population>The safety population included all ITT participants who received IV study drug. Participants were grouped according to the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>All Cause and Attributable Mortality by Day 28</title>
          <description>Number of patients experiencing all-cause and attributable mortality by Day 28. Attributable mortality was derived from the Complication of Influenza eCRF; all-cause mortality was derived from Complication of Influenza, Seven-Level Ordinal Scale, AE and Study Completion eCRFs</description>
          <population>The safety population included all ITT participants who received IV study drug. Participants were grouped according to the actual treatment received.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All-cause mortality Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attributable mortality Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All Cause and Attributable Mortality Day 56</title>
        <description>Number of patients experiencing all-cause and attributable mortality by Day 56. Attributable mortality was derived from the Complication of Influenza eCRF; all-cause mortality was derived from Complication of Influenza, Seven-Level Ordinal Scale, AE and Study Completion eCRFs</description>
        <time_frame>Day 56</time_frame>
        <population>The safety population included all ITT participants who received IV study drug. Participants were grouped according to the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>All Cause and Attributable Mortality Day 56</title>
          <description>Number of patients experiencing all-cause and attributable mortality by Day 56. Attributable mortality was derived from the Complication of Influenza eCRF; all-cause mortality was derived from Complication of Influenza, Seven-Level Ordinal Scale, AE and Study Completion eCRFs</description>
          <population>The safety population included all ITT participants who received IV study drug. Participants were grouped according to the actual treatment received.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All-cause mortality Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attributable mortality Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healthcare Resource Utilization. Days in Hospital and/or ICU</title>
        <description>Total number of days in hospital and/or ICU from admission to discharge</description>
        <time_frame>Day 56</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Healthcare Resource Utilization. Days in Hospital and/or ICU</title>
          <description>Total number of days in hospital and/or ICU from admission to discharge</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" spread="8.6"/>
                    <measurement group_id="O2" value="9.6" spread="7.02"/>
                    <measurement group_id="O3" value="10.5" spread="7.84"/>
                    <measurement group_id="O4" value="9.6" spread="6.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of Ordinal Scale Parameters - Days in Hospital/ICU</title>
        <description>Total number of days in hospital or intensive care for participations who were admitted to Hospital/ICU, including participants in Hospital/ICU at baseline. Better and worse outcome groups defined based on the Seven-Level Ordinal Scale scores, &quot;&lt;= 4 Seven-Level Ordinal Scale Score&quot; is better; &quot;&gt; 4 Seven-Level Ordinal Scale Score&quot; is worse group.&#xD;
Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.</description>
        <time_frame>56 days</time_frame>
        <population>Participants requiring ventilation from the mITT population. The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Ordinal Scale Parameters - Days in Hospital/ICU</title>
          <description>Total number of days in hospital or intensive care for participations who were admitted to Hospital/ICU, including participants in Hospital/ICU at baseline. Better and worse outcome groups defined based on the Seven-Level Ordinal Scale scores, &quot;&lt;= 4 Seven-Level Ordinal Scale Score&quot; is better; &quot;&gt; 4 Seven-Level Ordinal Scale Score&quot; is worse group.&#xD;
Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.</description>
          <population>Participants requiring ventilation from the mITT population. The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt; 4 Seven-Level Ordinal Scale Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9" spread="12.47"/>
                    <measurement group_id="O2" value="12.6" spread="9.08"/>
                    <measurement group_id="O3" value="14.3" spread="10.85"/>
                    <measurement group_id="O4" value="13.8" spread="9.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;= 4 Seven-Level Ordinal Scale Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="36"/>
                    <count group_id="O4" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="3.01"/>
                    <measurement group_id="O2" value="7.9" spread="5.13"/>
                    <measurement group_id="O3" value="8.3" spread="4.16"/>
                    <measurement group_id="O4" value="8.9" spread="5.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Rehospitalization Due to Relapse</title>
        <description>Number of participants with rehospitalization due to influenza A relapse</description>
        <time_frame>Day 56</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Rehospitalization Due to Relapse</title>
          <description>Number of participants with rehospitalization due to influenza A relapse</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Rehospitalization due to relapse--Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rehospitalization due to relapse--No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="54"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Influenza-related Complications</title>
        <description>Summary of influenza symptom complications, including baseline and incident complications</description>
        <time_frame>Day 56</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Influenza-related Complications</title>
          <description>Summary of influenza symptom complications, including baseline and incident complications</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with at least 1 complication of Influenza</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with pneumonia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with sinusitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other chronic pulmonary disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bacterial pneumonia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Maximum Concentration (Cmax) of VIS410 in Participant's Serum</title>
        <description>Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by maximum concentration (Cmax) of VIS410 in participant's serum.</description>
        <time_frame>Baseline, end of infusion, Day 5, Day 14, Day 28, Day 56</time_frame>
        <population>The PK population included all participants who received IV study drug and had at least 1 PK parameter that could be calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>The Maximum Concentration (Cmax) of VIS410 in Participant's Serum</title>
          <description>Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by maximum concentration (Cmax) of VIS410 in participant's serum.</description>
          <population>The PK population included all participants who received IV study drug and had at least 1 PK parameter that could be calculated.</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1301.037" spread="241.0838"/>
                    <measurement group_id="O2" value="786.393" spread="202.7963"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Area Under the Concentration/Time Curve of VIS410 in Participant's Serum</title>
        <description>Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the area under the concentration/time curve from 0 to infinity (AUC0-inf) of VIS410 in participant's serum.</description>
        <time_frame>Baseline, end of infusion, Day 5, Day 14, Day 28, Day 56</time_frame>
        <population>The PK population included all participants who received IV study drug and had at least 1 PK parameter that could be calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>The Area Under the Concentration/Time Curve of VIS410 in Participant's Serum</title>
          <description>Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the area under the concentration/time curve from 0 to infinity (AUC0-inf) of VIS410 in participant's serum.</description>
          <population>The PK population included all participants who received IV study drug and had at least 1 PK parameter that could be calculated.</population>
          <units>day*µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11326.522" spread="4205.1144"/>
                    <measurement group_id="O2" value="6934.815" spread="2304.3093"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Clearance Rate (Cl) of VIS410 in Participant's Serum</title>
        <description>Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the clearance rate (Cl) of VIS410 in participant's serum.</description>
        <time_frame>PK samples were collected on days 1, 5, 14, 28 and 56.</time_frame>
        <population>The PK population included all participants who received IV study drug and had at least 1 PK parameter that could be calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>The Clearance Rate (Cl) of VIS410 in Participant's Serum</title>
          <description>Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the clearance rate (Cl) of VIS410 in participant's serum.</description>
          <population>The PK population included all participants who received IV study drug and had at least 1 PK parameter that could be calculated.</population>
          <units>mL/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="401.652" spread="143.6763"/>
                    <measurement group_id="O2" value="325.926" spread="137.6743"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Half-life of VIS410 in Participant's Serum</title>
        <description>Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the half-life (t1/2) of VIS410 in participant's serum.</description>
        <time_frame>PK samples were collected on days 1, 5, 14, 28 and 56.</time_frame>
        <population>The PK population included all participants who received IV study drug and had at least 1 PK parameter that could be calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>The Half-life of VIS410 in Participant's Serum</title>
          <description>Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the half-life (t1/2) of VIS410 in participant's serum.</description>
          <population>The PK population included all participants who received IV study drug and had at least 1 PK parameter that could be calculated.</population>
          <units>mL/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.407" spread="3.5549"/>
                    <measurement group_id="O2" value="9.839" spread="3.2465"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-VIS410 Antibody Testing</title>
        <description>Summary of the maximum fold increase for anti-VIS410 antibody testing for VIS410 groups and placebo.</description>
        <time_frame>From anti-VIS410 antibody samples collected on days 28 and 56.</time_frame>
        <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>VIS410 High Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O2">
            <title>VIS410 Low Dose</title>
            <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
          </group>
          <group group_id="O3">
            <title>VIS410 Total</title>
            <description>Combined results from VIS410 high and low dose groups</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-VIS410 Antibody Testing</title>
          <description>Summary of the maximum fold increase for anti-VIS410 antibody testing for VIS410 groups and placebo.</description>
          <population>The modified ITT (MITT) population included all participants who received IV study drug and were confirmed influenza A positive by qRT-PCR in central lab analysis of pre-dose Day 1 and/or post-dose Day 1. Participants were grouped according to the randomly assigned treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="51"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1 to 4 fold</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="46"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;4 to 16 fold</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;16 to 64 fold</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;64 fold</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Patients were monitored for adverse events for 55 days following dosing of VIS410 or placebo.</time_frame>
      <desc>Each adverse event was graded on a 4-point scale (Grades 1-4) of increasing intensity according to the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table.</desc>
      <group_list>
        <group group_id="E1">
          <title>VIS410 High Dose</title>
          <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 4000 mg in addition to oseltamivir</description>
        </group>
        <group group_id="E2">
          <title>VIS410 Low Dose</title>
          <description>VIS410 liquid for infusion. Single, fixed, intravenous dose of 2000 mg in addition to oseltamivir</description>
        </group>
        <group group_id="E3">
          <title>Total VIS410</title>
          <description>Combined results from VIS410 high and low dose groups.</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>Single intravenous infusion of placebo in addition to oseltamivir</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Multiple Organ Dysfunction Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Septic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Neurological decompensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Respiratory Distress Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The institution may not publish study results until publication of the results of the full study or 2 years after study completion.&#xD;
The institution must provide a copy of any proposed publication to the Sponsor at least 40 days in advance&#xD;
The Sponsor may:&#xD;
provide comments on the proposed publication;&#xD;
request delay of the publication for 120 days;&#xD;
request that specified confidential information be removed</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Approximately 120 participants were planned to be included in the study. A total of 89 participants were randomized to treatment of which 73 subjects completed the trial.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Head of Regulatory Affairs</name_or_title>
      <organization>Visterra Inc.</organization>
      <phone>+1 617-498-1070</phone>
      <email>info@visterrainc.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03040141
org study id: VIS410-203
nct id: NCT03040141
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is to compare the efficacy and safety of VIS410 in combination with oseltamivir vs
      oseltamivir alone in severely ill subjects with influenza A infection requiring oxygen
      support.
This study is to compare the efficacy and safety of VIS410 in combination with oseltamivir vs
      oseltamivir alone in severely ill subjects with influenza A infection requiring oxygen
      support. Subjects will be followed for 56 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-blind
measure: Clinical Status of Participants on Day 7
time frame: 7 days
description: Evaluate the effect of 2 dose levels of VIS410 + oseltamivir on clinical status using a seven-level ordinal scale. Comparison between treatment groups and between all VIS410 recipients versus placebo were assessed.
measure: The Number of Participants With Adverse Events and Serious Adverse Events Following Administration of VIS410
time frame: 56 days
description: Safety and tolerability of 2 dose levels of a single intravenous (IV) dose of VIS410 when administered in combination with oseltamivir in hospitalized participants with influenza A infection. Data presents the count of participants who experienced an adverse event (AE) or serious treatment emergent adverse events (TEAE).
measure: Time to Cessation of Oxygen Support Compared to Oseltamivir Alone Among Patients Requiring Supplemental Oxygen Therapy With Baseline Room Air <= 92%
time frame: Baseline to Day 56
description: Time to cessation of O2 support in patients with supplemental oxygen with baseline room air <= 92%. Patients with treatment resulting in a stable SpO2 by pulse oximetry. Stable SpO2 is defined as two consecutive SpO2 values of >92% on room air that are at least 8 hours apart.
measure: Time to Cessation of Oxygen Support for Any Patient Requiring Supplemental Oxygen Therapy
time frame: Baseline to Day 56
description: Time to cessation of oxygen support in all patients with supplemental oxygen (regardless of oxygen saturation).
measure: Viral Titer in Upper Respiratory Samples by qRT-PCR
time frame: Day 14
description: The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in peak viral load by qRT-PCR from nasopharyngeal swabs through Day 14
measure: Viral Nasopharyngeal AUC
time frame: Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5
description: The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in nasopharyngeal qRT-PCR area under the viral load-time curve (AUC) from baseline to Day 5.
measure: Area Under the Viral Load-Time Curve (VL AUC) Based on qRT-PCR From Nasopharyngeal Swabs Through Day 7
time frame: Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5, Day 7
description: The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in nasopharyngeal qRT-PCR area under the viral load-time curve (AUC) from baseline to Day 7.
measure: Area Under the Viral Load-Time Curve (VL AUC) Based on qRT-PCR From Nasopharyngeal Swabs Through Day 14
time frame: Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5, Day 7, Day 14
description: The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in nasopharyngeal qRT-PCR area under the viral load-time curve (AUC) from baseline to Day 14.
measure: Median Time to Resolution of Viral Load by Treatment Arm by qRT-PCR - From End of Infusion
time frame: 14 days
description: Number of days from the end of infusion until virus is no longer detectable (at or below the limit of detection) with no samples following that are greater than the BLQ through the Day 14 (quantitative reverse-transcription polymerase chain reaction - qRT-PCR)
measure: Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by qRT-PCR
time frame: 14 days
description: Number of participants in whom peak viral load is observed post-baseline based on quantitative reverse-transcription polymerase chain reaction (qRT-PCR). Post-baseline was considered the day 3 sample or later.
measure: Peak Viral Load by TCID50
time frame: Day 7
description: Peak viral load based on TCID50 from nasopharyngeal swabs
measure: Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by TCID50
time frame: 56 days
description: Number of participants in whom peak viral load occurred post-baseline measured by TCID50. Post-baseline was considered the day 3 sample or later.
measure: Viral Nasopharyngeal AUC by TCID50
time frame: 5 days
description: The area under the viral load-time curve (AUC) for VIS410 + oseltamivir and oseltamivir alone treatment groups from baseline to Day 5 measured by TCID50 from nasopharyngeal swabs.
measure: Viral Nasopharyngeal AUC by TCID50
time frame: 7 days
description: The area under the viral load-time curve (AUC) for VIS410 + oseltamivir and oseltamivir alone treatment groups from baseline to Day 7 measured by TCID50 from nasopharyngeal swabs.
measure: Negative Viral Cultures by Study Day
time frame: Nominal days 3, 5, 7
description: Number of participants negative for viral titer by study day determined by TCID50 on nominal days 3, 5, 7
measure: Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From End of Infusion
time frame: 7 Days
description: Number of days from the end of infusion until virus is no longer detectable (at or below the limit of detection) with no samples following that are greater than the BLQ through the Day 7 (TCID50)
measure: Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From Onset of Symptoms
time frame: 7 Days
description: Number of days from the onset of symptoms until virus is no longer detectable (at or below the limit of detection) with no samples following that are greater than the BLQ through the Day 7 (TCID50)
measure: Time to Clinical Response (4 Out of 5 Vital Signs)
time frame: Day 56
description: Median time to clinical response defined by resolution of at least 4 of 5 vital signs:
Afebrile with core temperature ≤ 37.8°C, without use of antipyretics (oral ≤ 37.2°C)
Oxygen saturation ≥ 95% on room air without support or a return to preinfection status, if pre-infection status was < 95%
Pulse rate ≤ 100/min
Systolic blood pressure ≥ 90 mm/Hg, without vasopressor use
Respiratory rate ≤ 24 beats per minute
measure: Time to Complete Clinical Response (Resolution of All Vital Signs)
time frame: Day 56
description: Median time to clinical response defined by resolution of at all 5 vital signs:
Afebrile with core temperature ≤ 37.8°C, without use of antipyretics (oral ≤ 37.2°C)
Oxygen saturation ≥ 95% on room air without support or a return to pre-infection status, if pre-infection status was < 95%
Pulse rate ≤ 100/min
Systolic blood pressure ≥ 90 mm/Hg, without vasopressor use
Respiratory rate ≤ 24 beats per minute
measure: Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 7
time frame: Baseline to Day 7
description: Summary of area under the curve (AUC) over time for seven-level ordinal scale. Area under the curve (AUC) is calculated using the linear trapezoidal rule. Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities. Time frame is from baseline to day 7. Therefore, maximum and minimum values possible for the AUC Clinical Status Ordinal Scale scores range from 7 to 49.
measure: Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 14.
time frame: Baseline to Days 14
description: Summary of area under the curve (AUC) over time for seven-level ordinal scale. Area under the curve (AUC) is calculated using the linear trapezoidal rule. Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities. Time frame is from baseline to day 14. Therefore, maximum and minimum values possible for the AUC Clinical Status Ordinal Scale scores range from 14 to 98.
measure: Comparison of Clinical Status on Seven-level Ordinal Scale Scores
time frame: Day 14
description: Summary of Clinical Outcome on Seven-Level Ordinal Scale through Day 14. Worst post-baseline assessment observed.
Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.
measure: Total Number of Days on Ventilation
time frame: 56 days
description: Total number of days on ventilation for participants who used ventilation, including participants on ventilation at baseline
measure: Comparison of Ordinal Scale Parameters - Days on Ventilation
time frame: 56 days
description: Total number of days on ventilation for participations who used ventilation, including participants on ventilation at baseline. Better and worse outcome groups defined based on the Seven-Level Ordinal Scale scores, "<= 4 Seven-Level Ordinal Scale Score" is better; "> 4 Seven-Level Ordinal Scale Score" is worse group.
Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.
measure: Total Number of Days in ICU
time frame: 56 days
description: Total number of days in intensive care (ICU) for participants who admitted to the ICU, including participants in ICU at baseline
measure: Comparison of Ordinal Scale Parameters - Days in ICU
time frame: 56 days
description: Total number of days in intensive care for participants who admitted to ICU, including participants in ICU at baseline. Better and worse outcome groups defined based on the Seven-Level Ordinal Scale scores, "<= 4 Seven-Level Ordinal Scale Score" is better; "> 4 Seven-Level Ordinal Scale Score" is worse group.
Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.
measure: Number of Days to Resumption of Usual Activities
time frame: Day 56
description: Number of days until resumption of usual activities by treatment group
measure: All Cause and Attributable Mortality at Day 14
time frame: Day 14
description: Number of patients experiencing all-cause and attributable mortality rates at Day 14. Attributable mortality was derived from the Complication of Influenza eCRF; all-cause mortality was derived from Complication of Influenza, Seven-Level Ordinal Scale, AE and Study Completion eCRFs
measure: All Cause and Attributable Mortality by Day 28
time frame: Day 28
description: Number of patients experiencing all-cause and attributable mortality by Day 28. Attributable mortality was derived from the Complication of Influenza eCRF; all-cause mortality was derived from Complication of Influenza, Seven-Level Ordinal Scale, AE and Study Completion eCRFs
measure: All Cause and Attributable Mortality Day 56
time frame: Day 56
description: Number of patients experiencing all-cause and attributable mortality by Day 56. Attributable mortality was derived from the Complication of Influenza eCRF; all-cause mortality was derived from Complication of Influenza, Seven-Level Ordinal Scale, AE and Study Completion eCRFs
measure: Healthcare Resource Utilization. Days in Hospital and/or ICU
time frame: Day 56
description: Total number of days in hospital and/or ICU from admission to discharge
measure: Comparison of Ordinal Scale Parameters - Days in Hospital/ICU
time frame: 56 days
description: Total number of days in hospital or intensive care for participations who were admitted to Hospital/ICU, including participants in Hospital/ICU at baseline. Better and worse outcome groups defined based on the Seven-Level Ordinal Scale scores, "<= 4 Seven-Level Ordinal Scale Score" is better; "> 4 Seven-Level Ordinal Scale Score" is worse group.
Seven-Level Ordinal Scale is a hierarchical scale with the classifications presented from the worst clinical outcome to the best clinical outcome in descending order with 7=death, 6=Intensive care unit (ICU) stay with mechanical ventilation , 5=ICU stay without mechanical ventilation, 4=Non-ICU hospitalization with supplemental oxygen, 3=Non-ICU hospitalization without supplemental oxygen, 2=Discharge with partial resumption of normal activities, 1=Discharge with full resumption of normal activities.
measure: Number of Participants With Rehospitalization Due to Relapse
time frame: Day 56
description: Number of participants with rehospitalization due to influenza A relapse
measure: Number of Participants With Influenza-related Complications
time frame: Day 56
description: Summary of influenza symptom complications, including baseline and incident complications
measure: The Maximum Concentration (Cmax) of VIS410 in Participant's Serum
time frame: Baseline, end of infusion, Day 5, Day 14, Day 28, Day 56
description: Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by maximum concentration (Cmax) of VIS410 in participant's serum.
measure: The Area Under the Concentration/Time Curve of VIS410 in Participant's Serum
time frame: Baseline, end of infusion, Day 5, Day 14, Day 28, Day 56
description: Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the area under the concentration/time curve from 0 to infinity (AUC0-inf) of VIS410 in participant's serum.
measure: The Clearance Rate (Cl) of VIS410 in Participant's Serum
time frame: PK samples were collected on days 1, 5, 14, 28 and 56.
description: Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the clearance rate (Cl) of VIS410 in participant's serum.
measure: The Half-life of VIS410 in Participant's Serum
time frame: PK samples were collected on days 1, 5, 14, 28 and 56.
description: Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the half-life (t1/2) of VIS410 in participant's serum.
measure: Anti-VIS410 Antibody Testing
time frame: From anti-VIS410 antibody samples collected on days 28 and 56.
description: Summary of the maximum fold increase for anti-VIS410 antibody testing for VIS410 groups and placebo.
arm group label: VIS410 low dose
arm group type: Experimental
description: Single intravenous infusion of fixed low dose of VIS410 in addition to oseltamivir
arm group label: VIS410 high dose
arm group type: Experimental
description: Single intravenous infusion of fixed high dose of VIS410 in addition to oseltamivir
arm group label: Placebo
arm group type: Placebo Comparator
description: Single intravenous infusion of placebo in addition to oseltamivir
intervention type: Drug
intervention name: Low dose of VIS410
description: Single intravenous infusion of fixed low dose of VIS410 in addition to oseltamivir
arm group label: VIS410 low dose
other name: oseltamivir
intervention type: Drug
intervention name: High dose of VIS410
description: Single intravenous infusion of fixed high dose of VIS410 in addition to oseltamivir
arm group label: VIS410 high dose
other name: oseltamivir
intervention type: Drug
intervention name: Placebo
description: Single intravenous infusion of placebo in addition to oseltamivir
arm group label: Placebo
other name: oseltamivir
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Oldach, MD
role: Principal Investigator
affiliation: Visterra, Inc.
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country: Australia
country: Belarus
country: Belgium
country: Bulgaria
country: Canada
country: Estonia
country: France
country: Georgia
country: Latvia
country: Malaysia
country: New Zealand
country: Russian Federation
country: Serbia
country: Singapore
country: South Africa
country: Spain
country: Thailand
country: Turkey
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Oseltamivir
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Approximately 120 participants were planned to be included in the study. A total of 89 participants were randomized to treatment of which 73 subjects completed the trial.
point of contact: 