Influenza APhase 2NCT03040141
Study of Efficacy and Safety of IV VIS410 Plus Oseltamivir Versus Oseltamivir in Hospitalized Adults With Influenza A
A Phase 2 study testing Low dose of VIS410 and High dose of VIS410 in people with Influenza A, run by Visterra, Inc. at 114 sites in 20 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza A
- What is being tested?
- Low dose of VIS410 and High dose of VIS410
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 114 sitesin 20 countries
- Study dates
- 3 Jan 2018to 22 Nov 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
114 sites in 20 countries.
114 sites in 20 countries
United States21 sites
Visterra
Albany, New York, 12208
Visterra
Allentown, Pennsylvania, 18103
Visterra
Atlanta, Georgia, 30342
Visterra
Blackfoot, Idaho, 83221
Visterra
Butte, Montana, 59701
Visterra
Chicago, Illinois, 60637
Visterra
Cleveland, Ohio, 44195
Visterra
Columbus, Ohio, 43215
Visterra
Decatur, Georgia, 30033
Visterra
Detroit, Michigan, 48202
Visterra
Durham, North Carolina, 27710
Visterra
Greensboro, North Carolina, 27403
Visterra
Philadelphia, Pennsylvania, 19141
Visterra
Richland, Washington, 99352
Visterra
Roanoke, Virginia, 24014
Visterra
St. Petersburg, Florida, 33713
Visterra
Stanford, California, 94305
Visterra
Syracuse, New York, 13210
Visterra
Tacoma, Washington, 98405
Visterra
Tucson, Arizona, 85724
Visterra
York, Pennsylvania, 17405
Spain9 sites
Visterra
Alicante, 03010
Visterra
Badalona, 08916
Visterra
Barakaldo, 48903
Visterra
Barcelona, 08035
Visterra
Córdoba, 14004
Visterra
Granada, 18016
Visterra
Madrid, 28007
Visterra
Madrid, 28046
Visterra
Terrassa, 08221
Belarus8 sites
Visterra
Brest, 224027
Visterra
Grodno, 230017
Visterra
Grodno, 230030
Visterra
Homyel, 246029
Visterra
Homyel, 246044
Visterra
Lesnoy, 223041
Visterra
Minsk, 220024
Visterra
Vitebsk, 210009
France8 sites
Visterra
La Roche-sur-Yon, 85000
Visterra
La Tronche, 38700
Visterra
Limoges, 87000
Visterra
Metz-Tessy, 74370
Visterra
Nantes, 44000
Visterra
Paris, 75014
Visterra
Paris, 75018
Visterra
Quimper, 29000
South Africa8 sites
Visterra
Auckland Park, Gauteng, 2006
Visterra
Benoni, 1501
Visterra
Cape Town, 7570
Visterra
Durban, 4092
Visterra
Lyttelton, Centurion, 0157
Visterra
Pretoria, Gauteng, 0002
Visterra
Thabazimbi, Limpopo, 0380
Visterra
Worcester, 6850
Bulgaria7 sites
Visterra
Kozloduy, 3320
Visterra
Montana, 3400
Visterra
Plovdiv, 4002
Visterra
Sofia, 1233
Visterra
Sofia, 1431
Visterra
Sofia, 1606
Visterra
Veliko Tarnovo, 5000
Ukraine7 sites
Visterra
Ivano-Frankivsk, 76008
Visterra
Kyiv, 01133
Visterra
Kyiv, 04112
Visterra
Odesa, 65023
Visterra
Poltava, 36038
Visterra
Sumy, 40021
Visterra
Zhytomyr, 10002
Australia6 sites
Visterra
Adelaide, South Australia, 5000
Visterra
Melbourne, 3168
Visterra
Parkville, 3050
Visterra
South Brisbane, 4101
Visterra
Westmead, 2145
Visterra
Woolloongabba, 4102
Latvia6 sites
Visterra
Daugavpils, LV5417
Visterra
Liepāja, LV3414
Visterra
Rēzekne, LV4600
Visterra
Riga, LV 1002
Visterra
Valmiera, LV4201
Visterra
Ventspils, LV3601
Russia6 sites
Visterra
Arkhangelsk, 163045
Visterra
Kazan', 420140
Visterra
Novosibirsk, 630051
Visterra
Smolensk, 214006
Visterra
Tomsk, 634063
Visterra
Vladimir, 600023
Estonia5 sites
Visterra
Pärnu, 80010
Visterra
Tallinn, 10138
Visterra
Tallinn, 10617
Visterra
Tallinn, 113419
Visterra
Tartu, 51014
Georgia3 sites
Visterra
Tbilisi, 0144
Visterra
Tbilisi, 0159
Visterra
Tbilisi, 0160
Malaysia3 sites
Visterra
Alor Star, Kedah, 05350
Visterra
Kuala Lumpur, Kuala Lumpur, 50586
Visterra
Taiping, Perak, 34000
New Zealand3 sites
Visterra
Auckland, 1023
Visterra
Auckland, 2025
Visterra
Wellington, 6021
Serbia3 sites
Visterra
Kragujevac, 34000
Visterra
Niš, 18000
Visterra
Novi Sad, 21000
Thailand3 sites
Visterra
Bangkok, 10110
Visterra
Khon Kaen, 40002
Visterra
Nonthaburi, 11000
Turkey (Türkiye)3 sites
Visterra
Ankara, 06230
Visterra
Istanbul, 34098
Visterra
Trabzon, 61080
About this study
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
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.
Read the 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.
- Conditions
- Influenza A
- Being tested
- Low dose of VIS410, High dose of VIS410, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose of VIS410Drug
Also called oseltamivir
Single intravenous infusion of fixed low dose of VIS410 in addition to oseltamivir
High dose of VIS410Drug
Also called oseltamivir
Single intravenous infusion of fixed high dose of VIS410 in addition to oseltamivir
PlaceboDrug
Also called oseltamivir
Single intravenous infusion of placebo in addition to oseltamivir
| Study group | Role | What they receive |
|---|---|---|
| VIS410 low dose | Experimental | Single intravenous infusion of fixed low dose of VIS410 in addition to oseltamivir Receives: Drug: Low dose of VIS410 |
| VIS410 high dose | Experimental | Single intravenous infusion of fixed high dose of VIS410 in addition to oseltamivir Receives: Drug: High dose of VIS410 |
| Placebo | Placebo comparator | Single intravenous infusion of placebo in addition to oseltamivir Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
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).
Measured: 56 days
Secondary outcomes (37)
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.
Measured: Baseline to Day 56
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).
Measured: Baseline to Day 56
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
Measured: 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.
Measured: Day 1 Predose, Day 1 End of Infusion, Day 3, 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.
Measured: Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5, 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.
Measured: Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5, Day 7, 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)
Measured: 14 days
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.
Measured: 14 days
Peak Viral Load by TCID50
Peak viral load based on TCID50 from nasopharyngeal swabs
Measured: Day 7
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.
Measured: 56 days
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.
Measured: 5 days
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.
Measured: 7 days
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
Measured: 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)
Measured: 7 Days
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)
Measured: 7 Days
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
Measured: Day 56
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
Measured: Day 56
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.
Measured: Baseline to Day 7
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.
Measured: Baseline to Days 14
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.
Measured: Day 14
Total Number of Days on Ventilation
Total number of days on ventilation for participants who used ventilation, including participants on ventilation at baseline
Measured: 56 days
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.
Measured: 56 days
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
Measured: 56 days
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.
Measured: 56 days
Number of Days to Resumption of Usual Activities
Number of days until resumption of usual activities by treatment group
Measured: Day 56
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
Measured: Day 14
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
Measured: Day 28
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
Measured: Day 56
Healthcare Resource Utilization. Days in Hospital and/or ICU
Total number of days in hospital and/or ICU from admission to discharge
Measured: Day 56
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.
Measured: 56 days
Number of Participants With Rehospitalization Due to Relapse
Number of participants with rehospitalization due to influenza A relapse
Measured: Day 56
Number of Participants With Influenza-related Complications
Summary of influenza symptom complications, including baseline and incident complications
Measured: Day 56
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.
Measured: Baseline, end of infusion, Day 5, Day 14, Day 28, Day 56
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.
Measured: Baseline, end of infusion, Day 5, Day 14, Day 28, Day 56
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.
Measured: PK samples were collected on days 1, 5, 14, 28 and 56.
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.
Measured: PK samples were collected on days 1, 5, 14, 28 and 56.
Anti-VIS410 Antibody Testing
Summary of the maximum fold increase for anti-VIS410 antibody testing for VIS410 groups and placebo.
Measured: From anti-VIS410 antibody samples collected on days 28 and 56.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start3 Jan 2018
- Primary completion22 Nov 2018
- Study completion22 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Influenza AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visterra, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Oldach, MD, Principal investigator, Visterra, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040141
- Sponsor's protocol ID
- VIS410-203
- Status last verified
- Dec 2022
- First submitted
- 23 Jan 2017
- Last updated
- 28 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03040141
- Acronym / sponsor ID
- VIS410-203
- Conditions
- Influenza A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Visterra, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 22 Nov 2018 (actual)
- Study completion
- 22 Nov 2018 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Posted 28 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VIS410 low dose | Experimental | Drug: Low dose of VIS410Single intravenous infusion of fixed low dose of VIS410 in addition to oseltamivir |
| VIS410 high dose | Experimental | Drug: High dose of VIS410Single intravenous infusion of fixed high dose of VIS410 in addition to oseltamivir |
| Placebo | Placebo comparator | Drug: PlaceboSingle intravenous infusion of placebo in addition to oseltamivir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose of VIS410Also: oseltamivirSingle intravenous infusion of fixed low dose of VIS410 in addition to oseltamivir | Drug | VIS410 low dose |
| High dose of VIS410Also: oseltamivirSingle intravenous infusion of fixed high dose of VIS410 in addition to oseltamivir | Drug | VIS410 high dose |
| PlaceboAlso: oseltamivirSingle intravenous infusion of placebo in addition to oseltamivir | Drug | Placebo |
Primary outcome
Clinical Status of Participants on Day 7
Time frame: 7 days
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
Time frame: 56 days
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).
37 secondary outcomes
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
Time to Cessation of Oxygen Support for Any Patient Requiring Supplemental Oxygen Therapy
Time frame: Baseline to Day 56
Viral Titer in Upper Respiratory Samples by qRT-PCR
Time frame: Day 14
Viral Nasopharyngeal AUC
Time frame: Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5
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
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
Median Time to Resolution of Viral Load by Treatment Arm by qRT-PCR - From End of Infusion
Time frame: 14 days
Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by qRT-PCR
Time frame: 14 days
Peak Viral Load by TCID50
Time frame: Day 7
Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by TCID50
Time frame: 56 days
Viral Nasopharyngeal AUC by TCID50
Time frame: 5 days
Viral Nasopharyngeal AUC by TCID50
Time frame: 7 days
Negative Viral Cultures by Study Day
Time frame: Nominal days 3, 5, 7
Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From End of Infusion
Time frame: 7 Days
Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From Onset of Symptoms
Time frame: 7 Days
Time to Clinical Response (4 Out of 5 Vital Signs)
Time frame: Day 56
Time to Complete Clinical Response (Resolution of All Vital Signs)
Time frame: Day 56
Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 7
Time frame: Baseline to Day 7
Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 14.
Time frame: Baseline to Days 14
Comparison of Clinical Status on Seven-level Ordinal Scale Scores
Time frame: Day 14
Total Number of Days on Ventilation
Time frame: 56 days
Comparison of Ordinal Scale Parameters - Days on Ventilation
Time frame: 56 days
Total Number of Days in ICU
Time frame: 56 days
Comparison of Ordinal Scale Parameters - Days in ICU
Time frame: 56 days
Number of Days to Resumption of Usual Activities
Time frame: Day 56
All Cause and Attributable Mortality at Day 14
Time frame: Day 14
All Cause and Attributable Mortality by Day 28
Time frame: Day 28
All Cause and Attributable Mortality Day 56
Time frame: Day 56
Healthcare Resource Utilization. Days in Hospital and/or ICU
Time frame: Day 56
Comparison of Ordinal Scale Parameters - Days in Hospital/ICU
Time frame: 56 days
Number of Participants With Rehospitalization Due to Relapse
Time frame: Day 56
Number of Participants With Influenza-related Complications
Time frame: Day 56
The Maximum Concentration (Cmax) of VIS410 in Participant's Serum
Time frame: Baseline, end of infusion, Day 5, Day 14, Day 28, Day 56
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
The Clearance Rate (Cl) of VIS410 in Participant's Serum
Time frame: PK samples were collected on days 1, 5, 14, 28 and 56.
The Half-life of VIS410 in Participant's Serum
Time frame: PK samples were collected on days 1, 5, 14, 28 and 56.
Anti-VIS410 Antibody Testing
Time frame: From anti-VIS410 antibody samples collected on days 28 and 56.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Oldach, MD principal investigator
Visterra, Inc.
114 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low dose of VIS410 and High dose of VIS410 in people with Influenza A, run by Visterra, Inc. at 114 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 114 sites in United States, Spain, Belarus, France, South Africa and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Status of Participants on Day 7 (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.