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Study of Efficacy and Safety of IV VIS410 Plus Oseltamivir Versus Oseltamivir in Hospitalized Adults With Influenza A

Primary Purpose

Influenza A

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Low dose of VIS410
High dose of VIS410
Placebo
Sponsored by
Visterra, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza A

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female subjects aged ≥ 18 years.
  • Test positive for influenza A by rapid antigen test or with another commercially available test on an adequate nasopharyngeal specimen in accordance with the manufacturer's instructions, or an acceptable local test, including PCR (Polymerase chain reaction), FIA (Fluorescent immunoassay), or ELISA
  • Onset of influenza symptoms no more than 5 days before VIS410/placebo infusion; symptoms may include cough, dyspnea, sore throat, fever, myalgias, headache, nasal symptoms (rhinorrhea, congestion), fatigue, diarrhea, anorexia, nausea, and vomiting.
  • Requirement for oxygen support including any positive pressure ventilation
  • Women of childbearing potential must have a negative pregnancy test within 2 days prior to VIS410/placebo infusion.

  • Women should fulfill one of the following criteria:

    • Post-menopausal; either amenorrhea ≥ 12 months or follicle stimulating hormone > 40 mIU/mL as documented in their medical history
    • Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation
    • Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception from screening until 60 days post VIS410/placebo infusion.
  • Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects who have a female partner of childbearing potential must use an effective birth control method from screening until 60 days post VIS410/placebo infusion.
  • Subject, or a legally acceptable representative (LAR), is able to understand the purpose and risks of the study and willing to give voluntary written informed consent.

Exclusion Criteria:

  • Known or suspected intolerance or hypersensitivity to VIS410, oseltamivir, pretreatment medications (diphenhydramine, or to both ibuprofen and acetylsalicylic acid [ASA]), or closely related compounds (eg, other monoclonal antibodies)
  • Subjects who have received VIS410 in the past
  • History of receiving monoclonal antibody products (including VIS410) within 3 months prior to VIS410/placebo dosing or planned administration during the study period
  • Subjects who have taken more than 6 doses of an approved antiviral therapy for influenza within the prior 96 hours (eg, oral oseltamivir, inhaled zanamivir, IV peramivir, or oral ribavirin) between onset of symptoms and VIS410/placebo dosing
  • Subjects with known co-infection with influenza B or other viral respiratory infections (e.g., respiratory syncytial virus, parainfluenza viruses, respiratory adenoviruses)
  • Subjects with lung transplant or history of severe chronic lung disease, including cystic fibrosis or any condition requiring home oxygen therapy
  • Subjects on extracorporeal membrane oxygenation (ECMO) at time of randomization
  • Subjects with end stage renal disease who are not undergoing hemodialysis
  • Subjects with active graft-vs-host disease, hematopoietic stem cell transplant within the previous 90 days, or human immunodeficiency virus infection with a CD4 cell count of less than 200 per cubic millimeter
  • Hospitalization for > 48 hours prior to randomization
  • High probability of mortality within 48 hours of randomization as determined by the Investigator
  • Subjects weighing less than 45 kg
  • Enrollment in any other investigational drug or device study, any disease or vaccine study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer
  • Known or suspected alcohol or drug abuse, that is, abuse of a level that would compromise the safety or cooperation of the subject in the opinion of the Investigator

Sites / Locations

  • Visterra
  • Visterra
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

VIS410 low dose

VIS410 high dose

Placebo

Arm Description

Single intravenous infusion of fixed low dose of VIS410 in addition to oseltamivir

Single intravenous infusion of fixed high dose of VIS410 in addition to oseltamivir

Single intravenous infusion of placebo in addition to oseltamivir

Outcomes

Primary Outcome Measures

Clinical Status of Participants on Day 7
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.
The Number of Participants With Adverse Events and Serious Adverse Events Following Administration of VIS410
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).

Secondary Outcome Measures

Time to Cessation of Oxygen Support Compared to Oseltamivir Alone Among Patients Requiring Supplemental Oxygen Therapy With Baseline Room Air <= 92%
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.
Time to Cessation of Oxygen Support for Any Patient Requiring Supplemental Oxygen Therapy
Time to cessation of oxygen support in all patients with supplemental oxygen (regardless of oxygen saturation).
Viral Titer in Upper Respiratory Samples by qRT-PCR
The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in peak viral load by qRT-PCR from nasopharyngeal swabs through Day 14
Viral Nasopharyngeal AUC
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.
Area Under the Viral Load-Time Curve (VL AUC) Based on qRT-PCR From Nasopharyngeal Swabs Through Day 7
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.
Area Under the Viral Load-Time Curve (VL AUC) Based on qRT-PCR From Nasopharyngeal Swabs Through Day 14
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.
Median Time to Resolution of Viral Load by Treatment Arm by qRT-PCR - From End of Infusion
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)
Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by qRT-PCR
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.
Peak Viral Load by TCID50
Peak viral load based on TCID50 from nasopharyngeal swabs
Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by TCID50
Number of participants in whom peak viral load occurred post-baseline measured by TCID50. Post-baseline was considered the day 3 sample or later.
Viral Nasopharyngeal AUC by TCID50
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.
Viral Nasopharyngeal AUC by TCID50
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.
Negative Viral Cultures by Study Day
Number of participants negative for viral titer by study day determined by TCID50 on nominal days 3, 5, 7
Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From End of Infusion
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)
Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From Onset of Symptoms
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)
Time to Clinical Response (4 Out of 5 Vital Signs)
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
Time to Complete Clinical Response (Resolution of All Vital Signs)
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
Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 7
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.
Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 14.
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.
Comparison of Clinical Status on Seven-level Ordinal Scale Scores
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.
Total Number of Days on Ventilation
Total number of days on ventilation for participants who used ventilation, including participants on ventilation at baseline
Comparison of Ordinal Scale Parameters - Days on Ventilation
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.
Total Number of Days in ICU
Total number of days in intensive care (ICU) for participants who admitted to the ICU, including participants in ICU at baseline
Comparison of Ordinal Scale Parameters - Days in ICU
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.
Number of Days to Resumption of Usual Activities
Number of days until resumption of usual activities by treatment group
All Cause and Attributable Mortality at Day 14
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
All Cause and Attributable Mortality by Day 28
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
All Cause and Attributable Mortality Day 56
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
Healthcare Resource Utilization. Days in Hospital and/or ICU
Total number of days in hospital and/or ICU from admission to discharge
Comparison of Ordinal Scale Parameters - Days in Hospital/ICU
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.
Number of Participants With Rehospitalization Due to Relapse
Number of participants with rehospitalization due to influenza A relapse
Number of Participants With Influenza-related Complications
Summary of influenza symptom complications, including baseline and incident complications
The Maximum Concentration (Cmax) of VIS410 in Participant's Serum
Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by maximum concentration (Cmax) of VIS410 in participant's serum.
The Area Under the Concentration/Time Curve of VIS410 in Participant's Serum
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.
The Clearance Rate (Cl) of VIS410 in Participant's Serum
Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the clearance rate (Cl) of VIS410 in participant's serum.
The Half-life of VIS410 in Participant's Serum
Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the half-life (t1/2) of VIS410 in participant's serum.
Anti-VIS410 Antibody Testing
Summary of the maximum fold increase for anti-VIS410 antibody testing for VIS410 groups and placebo.

Full Information

First Posted
January 23, 2017
Last Updated
December 9, 2022
Sponsor
Visterra, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03040141
Brief Title
Study of Efficacy and Safety of IV VIS410 Plus Oseltamivir Versus Oseltamivir in Hospitalized Adults With Influenza A
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
November 22, 2018 (Actual)
Study Completion Date
November 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Visterra, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VIS410 low dose
Arm Type
Experimental
Arm Description
Single intravenous infusion of fixed low dose of VIS410 in addition to oseltamivir
Arm Title
VIS410 high dose
Arm Type
Experimental
Arm Description
Single intravenous infusion of fixed high dose of VIS410 in addition to oseltamivir
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single intravenous infusion of placebo in addition to oseltamivir
Intervention Type
Drug
Intervention Name(s)
Low dose of VIS410
Other Intervention Name(s)
oseltamivir
Intervention Description
Single intravenous infusion of fixed low dose of VIS410 in addition to oseltamivir
Intervention Type
Drug
Intervention Name(s)
High dose of VIS410
Other Intervention Name(s)
oseltamivir
Intervention Description
Single intravenous infusion of fixed high dose of VIS410 in addition to oseltamivir
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
oseltamivir
Intervention Description
Single intravenous infusion of placebo in addition to oseltamivir
Primary Outcome Measure Information:
Title
Clinical Status of Participants on Day 7
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.
Time Frame
7 days
Title
The Number of Participants With Adverse Events and Serious Adverse Events Following Administration of VIS410
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).
Time Frame
56 days
Secondary Outcome Measure Information:
Title
Time to Cessation of Oxygen Support Compared to Oseltamivir Alone Among Patients Requiring Supplemental Oxygen Therapy With Baseline Room Air <= 92%
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.
Time Frame
Baseline to Day 56
Title
Time to Cessation of Oxygen Support for Any Patient Requiring Supplemental Oxygen Therapy
Description
Time to cessation of oxygen support in all patients with supplemental oxygen (regardless of oxygen saturation).
Time Frame
Baseline to Day 56
Title
Viral Titer in Upper Respiratory Samples by qRT-PCR
Description
The difference between VIS410 + oseltamivir and oseltamivir alone treatment groups in peak viral load by qRT-PCR from nasopharyngeal swabs through Day 14
Time Frame
Day 14
Title
Viral Nasopharyngeal AUC
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.
Time Frame
Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5
Title
Area Under the Viral Load-Time Curve (VL AUC) Based on qRT-PCR From Nasopharyngeal Swabs Through 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.
Time Frame
Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5, Day 7
Title
Area Under the Viral Load-Time Curve (VL AUC) Based on qRT-PCR From Nasopharyngeal Swabs Through 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.
Time Frame
Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5, Day 7, Day 14
Title
Median Time to Resolution of Viral Load by Treatment Arm by qRT-PCR - From End of Infusion
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)
Time Frame
14 days
Title
Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by qRT-PCR
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.
Time Frame
14 days
Title
Peak Viral Load by TCID50
Description
Peak viral load based on TCID50 from nasopharyngeal swabs
Time Frame
Day 7
Title
Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by TCID50
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.
Time Frame
56 days
Title
Viral Nasopharyngeal AUC by TCID50
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.
Time Frame
5 days
Title
Viral Nasopharyngeal AUC by TCID50
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.
Time Frame
7 days
Title
Negative Viral Cultures by Study Day
Description
Number of participants negative for viral titer by study day determined by TCID50 on nominal days 3, 5, 7
Time Frame
Nominal days 3, 5, 7
Title
Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From End of Infusion
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)
Time Frame
7 Days
Title
Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From Onset of Symptoms
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)
Time Frame
7 Days
Title
Time to Clinical Response (4 Out of 5 Vital Signs)
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
Time Frame
Day 56
Title
Time to Complete Clinical Response (Resolution of All Vital Signs)
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
Time Frame
Day 56
Title
Clinical Status Ordinal Scale Mean Area Under the Curve Through 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.
Time Frame
Baseline to Day 7
Title
Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 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.
Time Frame
Baseline to Days 14
Title
Comparison of Clinical Status on Seven-level Ordinal Scale Scores
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.
Time Frame
Day 14
Title
Total Number of Days on Ventilation
Description
Total number of days on ventilation for participants who used ventilation, including participants on ventilation at baseline
Time Frame
56 days
Title
Comparison of Ordinal Scale Parameters - Days on Ventilation
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.
Time Frame
56 days
Title
Total Number of Days in ICU
Description
Total number of days in intensive care (ICU) for participants who admitted to the ICU, including participants in ICU at baseline
Time Frame
56 days
Title
Comparison of Ordinal Scale Parameters - Days in ICU
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.
Time Frame
56 days
Title
Number of Days to Resumption of Usual Activities
Description
Number of days until resumption of usual activities by treatment group
Time Frame
Day 56
Title
All Cause and Attributable Mortality at 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
Time Frame
Day 14
Title
All Cause and Attributable Mortality by 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
Time Frame
Day 28
Title
All Cause and Attributable Mortality 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
Time Frame
Day 56
Title
Healthcare Resource Utilization. Days in Hospital and/or ICU
Description
Total number of days in hospital and/or ICU from admission to discharge
Time Frame
Day 56
Title
Comparison of Ordinal Scale Parameters - Days in Hospital/ICU
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.
Time Frame
56 days
Title
Number of Participants With Rehospitalization Due to Relapse
Description
Number of participants with rehospitalization due to influenza A relapse
Time Frame
Day 56
Title
Number of Participants With Influenza-related Complications
Description
Summary of influenza symptom complications, including baseline and incident complications
Time Frame
Day 56
Title
The Maximum Concentration (Cmax) of VIS410 in Participant's Serum
Description
Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by maximum concentration (Cmax) of VIS410 in participant's serum.
Time Frame
Baseline, end of infusion, Day 5, Day 14, Day 28, Day 56
Title
The Area Under the Concentration/Time Curve of VIS410 in Participant's Serum
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.
Time Frame
Baseline, end of infusion, Day 5, Day 14, Day 28, Day 56
Title
The Clearance Rate (Cl) of VIS410 in Participant's Serum
Description
Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the clearance rate (Cl) of VIS410 in participant's serum.
Time Frame
PK samples were collected on days 1, 5, 14, 28 and 56.
Title
The Half-life of VIS410 in Participant's Serum
Description
Summary of Serum VIS410 Pharmacokinetic Parameters in PK Population by the half-life (t1/2) of VIS410 in participant's serum.
Time Frame
PK samples were collected on days 1, 5, 14, 28 and 56.
Title
Anti-VIS410 Antibody Testing
Description
Summary of the maximum fold increase for anti-VIS410 antibody testing for VIS410 groups and placebo.
Time Frame
From anti-VIS410 antibody samples collected on days 28 and 56.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects aged ≥ 18 years. Test positive for influenza A by rapid antigen test or with another commercially available test on an adequate nasopharyngeal specimen in accordance with the manufacturer's instructions, or an acceptable local test, including PCR (Polymerase chain reaction), FIA (Fluorescent immunoassay), or ELISA Onset of influenza symptoms no more than 5 days before VIS410/placebo infusion; symptoms may include cough, dyspnea, sore throat, fever, myalgias, headache, nasal symptoms (rhinorrhea, congestion), fatigue, diarrhea, anorexia, nausea, and vomiting. Requirement for oxygen support including any positive pressure ventilation Women of childbearing potential must have a negative pregnancy test within 2 days prior to VIS410/placebo infusion. Women should fulfill one of the following criteria: Post-menopausal; either amenorrhea ≥ 12 months or follicle stimulating hormone > 40 mIU/mL as documented in their medical history Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception from screening until 60 days post VIS410/placebo infusion. Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects who have a female partner of childbearing potential must use an effective birth control method from screening until 60 days post VIS410/placebo infusion. Subject, or a legally acceptable representative (LAR), is able to understand the purpose and risks of the study and willing to give voluntary written informed consent. Exclusion Criteria: Known or suspected intolerance or hypersensitivity to VIS410, oseltamivir, pretreatment medications (diphenhydramine, or to both ibuprofen and acetylsalicylic acid [ASA]), or closely related compounds (eg, other monoclonal antibodies) Subjects who have received VIS410 in the past History of receiving monoclonal antibody products (including VIS410) within 3 months prior to VIS410/placebo dosing or planned administration during the study period Subjects who have taken more than 6 doses of an approved antiviral therapy for influenza within the prior 96 hours (eg, oral oseltamivir, inhaled zanamivir, IV peramivir, or oral ribavirin) between onset of symptoms and VIS410/placebo dosing Subjects with known co-infection with influenza B or other viral respiratory infections (e.g., respiratory syncytial virus, parainfluenza viruses, respiratory adenoviruses) Subjects with lung transplant or history of severe chronic lung disease, including cystic fibrosis or any condition requiring home oxygen therapy Subjects on extracorporeal membrane oxygenation (ECMO) at time of randomization Subjects with end stage renal disease who are not undergoing hemodialysis Subjects with active graft-vs-host disease, hematopoietic stem cell transplant within the previous 90 days, or human immunodeficiency virus infection with a CD4 cell count of less than 200 per cubic millimeter Hospitalization for > 48 hours prior to randomization High probability of mortality within 48 hours of randomization as determined by the Investigator Subjects weighing less than 45 kg Enrollment in any other investigational drug or device study, any disease or vaccine study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer Known or suspected alcohol or drug abuse, that is, abuse of a level that would compromise the safety or cooperation of the subject in the opinion of the Investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Oldach, MD
Organizational Affiliation
Visterra, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Visterra
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Visterra
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Visterra
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Visterra
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Visterra
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Visterra
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Visterra
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Visterra
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Visterra
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Visterra
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Visterra
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Visterra
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Visterra
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Visterra
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Visterra
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Visterra
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Visterra
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Visterra
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17405
Country
United States
Facility Name
Visterra
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Visterra
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States
Facility Name
Visterra
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Visterra
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Visterra
City
Melbourne
ZIP/Postal Code
3168
Country
Australia
Facility Name
Visterra
City
Parkville
ZIP/Postal Code
3050
Country
Australia
Facility Name
Visterra
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Facility Name
Visterra
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Visterra
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Visterra
City
Brest
ZIP/Postal Code
224027
Country
Belarus
Facility Name
Visterra
City
Gomel
ZIP/Postal Code
246029
Country
Belarus
Facility Name
Visterra
City
Gomel
ZIP/Postal Code
246044
Country
Belarus
Facility Name
Visterra
City
Grodno
ZIP/Postal Code
230017
Country
Belarus
Facility Name
Visterra
City
Grodno
ZIP/Postal Code
230030
Country
Belarus
Facility Name
Visterra
City
Lesnoy
ZIP/Postal Code
223041
Country
Belarus
Facility Name
Visterra
City
Minsk
ZIP/Postal Code
220024
Country
Belarus
Facility Name
Visterra
City
Vitebsk
ZIP/Postal Code
210009
Country
Belarus
Facility Name
Visterra
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Visterra
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Visterra
City
Kozloduy
ZIP/Postal Code
3320
Country
Bulgaria
Facility Name
Visterra
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
Visterra
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Visterra
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Visterra
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Visterra
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Visterra
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Visterra
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Visterra
City
Pärnu
ZIP/Postal Code
80010
Country
Estonia
Facility Name
Visterra
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Visterra
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Visterra
City
Tallinn
ZIP/Postal Code
113419
Country
Estonia
Facility Name
Visterra
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Visterra
City
La Roche-sur-Yon
ZIP/Postal Code
85000
Country
France
Facility Name
Visterra
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Visterra
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Visterra
City
Metz-Tessy
ZIP/Postal Code
74370
Country
France
Facility Name
Visterra
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Visterra
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Visterra
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Visterra
City
Quimper
ZIP/Postal Code
29000
Country
France
Facility Name
Visterra
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Facility Name
Visterra
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Visterra
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Visterra
City
Daugavpils
ZIP/Postal Code
LV5417
Country
Latvia
Facility Name
Visterra
City
Liepāja
ZIP/Postal Code
LV3414
Country
Latvia
Facility Name
Visterra
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Facility Name
Visterra
City
Rēzekne
ZIP/Postal Code
LV4600
Country
Latvia
Facility Name
Visterra
City
Valmiera
ZIP/Postal Code
LV4201
Country
Latvia
Facility Name
Visterra
City
Ventspils
ZIP/Postal Code
LV3601
Country
Latvia
Facility Name
Visterra
City
Alor Setar
State/Province
Kedah
ZIP/Postal Code
05350
Country
Malaysia
Facility Name
Visterra
City
Taiping
State/Province
Perak
ZIP/Postal Code
34000
Country
Malaysia
Facility Name
Visterra
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Visterra
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Visterra
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Visterra
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Visterra
City
Arkhangel'sk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Visterra
City
Kazan
ZIP/Postal Code
420140
Country
Russian Federation
Facility Name
Visterra
City
Novosibirsk
ZIP/Postal Code
630051
Country
Russian Federation
Facility Name
Visterra
City
Smolensk
ZIP/Postal Code
214006
Country
Russian Federation
Facility Name
Visterra
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Facility Name
Visterra
City
Vladimir
ZIP/Postal Code
600023
Country
Russian Federation
Facility Name
Visterra
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Visterra
City
Niš
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Visterra
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Visterra
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Visterra
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Visterra
City
Lyttelton
State/Province
Centurion
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Visterra
City
Auckland Park
State/Province
Gauteng
ZIP/Postal Code
2006
Country
South Africa
Facility Name
Visterra
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Visterra
City
Thabazimbi
State/Province
Limpopo
ZIP/Postal Code
0380
Country
South Africa
Facility Name
Visterra
City
Benoni
ZIP/Postal Code
1501
Country
South Africa
Facility Name
Visterra
City
Cape Town
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Visterra
City
Durban
ZIP/Postal Code
4092
Country
South Africa
Facility Name
Visterra
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Visterra
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Visterra
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Visterra
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Visterra
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Visterra
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Visterra
City
Granada
ZIP/Postal Code
18016
Country
Spain
Facility Name
Visterra
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Visterra
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Visterra
City
Terrassa
ZIP/Postal Code
08221
Country
Spain
Facility Name
Visterra
City
Bangkok
ZIP/Postal Code
10110
Country
Thailand
Facility Name
Visterra
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Visterra
City
Mueang Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Facility Name
Visterra
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Visterra
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Visterra
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Visterra
City
Ivano-Frankivs'k
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Visterra
City
Kyiv
ZIP/Postal Code
01133
Country
Ukraine
Facility Name
Visterra
City
Kyiv
ZIP/Postal Code
04112
Country
Ukraine
Facility Name
Visterra
City
Odesa
ZIP/Postal Code
65023
Country
Ukraine
Facility Name
Visterra
City
Poltava
ZIP/Postal Code
36038
Country
Ukraine
Facility Name
Visterra
City
Sumy
ZIP/Postal Code
40021
Country
Ukraine
Facility Name
Visterra
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Efficacy and Safety of IV VIS410 Plus Oseltamivir Versus Oseltamivir in Hospitalized Adults With Influenza A

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