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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03040141




Registration number
NCT03040141
Ethics application status
Date submitted
23/01/2017
Date registered
2/02/2017

Titles & IDs
Public title
Study of Efficacy and Safety of IV VIS410 Plus Oseltamivir Versus Oseltamivir in Hospitalized Adults With Influenza A
Scientific 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
Secondary ID [1] 0 0
VIS410-203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza A 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Low dose of VIS410
Treatment: Drugs - High dose of VIS410
Treatment: Drugs - Placebo

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

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

Placebo comparator: Placebo - Single intravenous infusion of placebo in addition to oseltamivir


Treatment: Drugs: Low dose of VIS410
Single intravenous infusion of fixed low dose of VIS410 in addition to oseltamivir

Treatment: Drugs: High dose of VIS410
Single intravenous infusion of fixed high dose of VIS410 in addition to oseltamivir

Treatment: Drugs: Placebo
Single intravenous infusion of placebo in addition to oseltamivir
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Status of Participants on Day 7
Timepoint [1] 0 0
7 days
Primary outcome [2] 0 0
The Number of Participants With Adverse Events and Serious Adverse Events Following Administration of VIS410
Timepoint [2] 0 0
56 days
Secondary outcome [1] 0 0
Time to Cessation of Oxygen Support Compared to Oseltamivir Alone Among Patients Requiring Supplemental Oxygen Therapy With Baseline Room Air <= 92%
Timepoint [1] 0 0
Baseline to Day 56
Secondary outcome [2] 0 0
Time to Cessation of Oxygen Support for Any Patient Requiring Supplemental Oxygen Therapy
Timepoint [2] 0 0
Baseline to Day 56
Secondary outcome [3] 0 0
Viral Titer in Upper Respiratory Samples by qRT-PCR
Timepoint [3] 0 0
Day 14
Secondary outcome [4] 0 0
Viral Nasopharyngeal AUC
Timepoint [4] 0 0
Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5
Secondary outcome [5] 0 0
Area Under the Viral Load-Time Curve (VL AUC) Based on qRT-PCR From Nasopharyngeal Swabs Through Day 7
Timepoint [5] 0 0
Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5, Day 7
Secondary outcome [6] 0 0
Area Under the Viral Load-Time Curve (VL AUC) Based on qRT-PCR From Nasopharyngeal Swabs Through Day 14
Timepoint [6] 0 0
Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5, Day 7, Day 14
Secondary outcome [7] 0 0
Median Time to Resolution of Viral Load by Treatment Arm by qRT-PCR - From End of Infusion
Timepoint [7] 0 0
14 days
Secondary outcome [8] 0 0
Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by qRT-PCR
Timepoint [8] 0 0
14 days
Secondary outcome [9] 0 0
Peak Viral Load by TCID50
Timepoint [9] 0 0
Day 7
Secondary outcome [10] 0 0
Number of Participants in Whom Peak Viral Load Occurred Post Baseline Measured by TCID50
Timepoint [10] 0 0
56 days
Secondary outcome [11] 0 0
Viral Nasopharyngeal AUC by TCID50
Timepoint [11] 0 0
5 days
Secondary outcome [12] 0 0
Viral Nasopharyngeal AUC by TCID50
Timepoint [12] 0 0
7 days
Secondary outcome [13] 0 0
Negative Viral Cultures by Study Day
Timepoint [13] 0 0
Nominal days 3, 5, 7
Secondary outcome [14] 0 0
Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From End of Infusion
Timepoint [14] 0 0
7 Days
Secondary outcome [15] 0 0
Median Time to Resolution of Viral Load by Treatment Arm by TCID50 - From Onset of Symptoms
Timepoint [15] 0 0
7 Days
Secondary outcome [16] 0 0
Time to Clinical Response (4 Out of 5 Vital Signs)
Timepoint [16] 0 0
Day 56
Secondary outcome [17] 0 0
Time to Complete Clinical Response (Resolution of All Vital Signs)
Timepoint [17] 0 0
Day 56
Secondary outcome [18] 0 0
Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 7
Timepoint [18] 0 0
Baseline to Day 7
Secondary outcome [19] 0 0
Clinical Status Ordinal Scale Mean Area Under the Curve Through Day 14.
Timepoint [19] 0 0
Baseline to Days 14
Secondary outcome [20] 0 0
Comparison of Clinical Status on Seven-level Ordinal Scale Scores
Timepoint [20] 0 0
Day 14
Secondary outcome [21] 0 0
Total Number of Days on Ventilation
Timepoint [21] 0 0
56 days
Secondary outcome [22] 0 0
Comparison of Ordinal Scale Parameters - Days on Ventilation
Timepoint [22] 0 0
56 days
Secondary outcome [23] 0 0
Total Number of Days in ICU
Timepoint [23] 0 0
56 days
Secondary outcome [24] 0 0
Comparison of Ordinal Scale Parameters - Days in ICU
Timepoint [24] 0 0
56 days
Secondary outcome [25] 0 0
Number of Days to Resumption of Usual Activities
Timepoint [25] 0 0
Day 56
Secondary outcome [26] 0 0
All Cause and Attributable Mortality at Day 14
Timepoint [26] 0 0
Day 14
Secondary outcome [27] 0 0
All Cause and Attributable Mortality by Day 28
Timepoint [27] 0 0
Day 28
Secondary outcome [28] 0 0
All Cause and Attributable Mortality Day 56
Timepoint [28] 0 0
Day 56
Secondary outcome [29] 0 0
Healthcare Resource Utilization. Days in Hospital and/or ICU
Timepoint [29] 0 0
Day 56
Secondary outcome [30] 0 0
Comparison of Ordinal Scale Parameters - Days in Hospital/ICU
Timepoint [30] 0 0
56 days
Secondary outcome [31] 0 0
Number of Participants With Rehospitalization Due to Relapse
Timepoint [31] 0 0
Day 56
Secondary outcome [32] 0 0
Number of Participants With Influenza-related Complications
Timepoint [32] 0 0
Day 56
Secondary outcome [33] 0 0
The Maximum Concentration (Cmax) of VIS410 in Participant's Serum
Timepoint [33] 0 0
Baseline, end of infusion, Day 5, Day 14, Day 28, Day 56
Secondary outcome [34] 0 0
The Area Under the Concentration/Time Curve of VIS410 in Participant's Serum
Timepoint [34] 0 0
Baseline, end of infusion, Day 5, Day 14, Day 28, Day 56
Secondary outcome [35] 0 0
The Clearance Rate (Cl) of VIS410 in Participant's Serum
Timepoint [35] 0 0
PK samples were collected on days 1, 5, 14, 28 and 56.
Secondary outcome [36] 0 0
The Half-life of VIS410 in Participant's Serum
Timepoint [36] 0 0
PK samples were collected on days 1, 5, 14, 28 and 56.
Secondary outcome [37] 0 0
Anti-VIS410 Antibody Testing
Timepoint [37] 0 0
From anti-VIS410 antibody samples collected on days 28 and 56.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/11/2018
Sample size
Target
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Visterra - Adelaide
Recruitment hospital [2] 0 0
Visterra - Melbourne
Recruitment hospital [3] 0 0
Visterra - Parkville
Recruitment hospital [4] 0 0
Visterra - South Brisbane
Recruitment hospital [5] 0 0
Visterra - Westmead
Recruitment hospital [6] 0 0
Visterra - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3168 - Melbourne
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Montana
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Belarus
State/province [15] 0 0
Brest
Country [16] 0 0
Belarus
State/province [16] 0 0
Gomel
Country [17] 0 0
Belarus
State/province [17] 0 0
Grodno
Country [18] 0 0
Belarus
State/province [18] 0 0
Lesnoy
Country [19] 0 0
Belarus
State/province [19] 0 0
Minsk
Country [20] 0 0
Belarus
State/province [20] 0 0
Vitebsk
Country [21] 0 0
Belgium
State/province [21] 0 0
Brussels
Country [22] 0 0
Belgium
State/province [22] 0 0
Edegem
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Kozloduy
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Montana
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Plovdiv
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Sofia
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Veliko Tarnovo
Country [28] 0 0
Canada
State/province [28] 0 0
New Brunswick
Country [29] 0 0
Estonia
State/province [29] 0 0
Pärnu
Country [30] 0 0
Estonia
State/province [30] 0 0
Tallinn
Country [31] 0 0
Estonia
State/province [31] 0 0
Tartu
Country [32] 0 0
France
State/province [32] 0 0
La Roche-sur-Yon
Country [33] 0 0
France
State/province [33] 0 0
La Tronche
Country [34] 0 0
France
State/province [34] 0 0
Limoges
Country [35] 0 0
France
State/province [35] 0 0
Metz-Tessy
Country [36] 0 0
France
State/province [36] 0 0
Nantes
Country [37] 0 0
France
State/province [37] 0 0
Paris
Country [38] 0 0
France
State/province [38] 0 0
Quimper
Country [39] 0 0
Georgia
State/province [39] 0 0
Tbilisi
Country [40] 0 0
Latvia
State/province [40] 0 0
Daugavpils
Country [41] 0 0
Latvia
State/province [41] 0 0
Liepaja
Country [42] 0 0
Latvia
State/province [42] 0 0
Riga
Country [43] 0 0
Latvia
State/province [43] 0 0
Rezekne
Country [44] 0 0
Latvia
State/province [44] 0 0
Valmiera
Country [45] 0 0
Latvia
State/province [45] 0 0
Ventspils
Country [46] 0 0
Malaysia
State/province [46] 0 0
Kedah
Country [47] 0 0
Malaysia
State/province [47] 0 0
Perak
Country [48] 0 0
Malaysia
State/province [48] 0 0
Wilayah Persekutuan
Country [49] 0 0
New Zealand
State/province [49] 0 0
Auckland
Country [50] 0 0
New Zealand
State/province [50] 0 0
Wellington
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Arkhangel'sk
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Kazan
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Novosibirsk
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Smolensk
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Tomsk
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Vladimir
Country [57] 0 0
Serbia
State/province [57] 0 0
Kragujevac
Country [58] 0 0
Serbia
State/province [58] 0 0
Niš
Country [59] 0 0
Serbia
State/province [59] 0 0
Novi Sad
Country [60] 0 0
Singapore
State/province [60] 0 0
Singapore
Country [61] 0 0
South Africa
State/province [61] 0 0
Centurion
Country [62] 0 0
South Africa
State/province [62] 0 0
Gauteng
Country [63] 0 0
South Africa
State/province [63] 0 0
Limpopo
Country [64] 0 0
South Africa
State/province [64] 0 0
Benoni
Country [65] 0 0
South Africa
State/province [65] 0 0
Cape Town
Country [66] 0 0
South Africa
State/province [66] 0 0
Durban
Country [67] 0 0
South Africa
State/province [67] 0 0
Worcester
Country [68] 0 0
Spain
State/province [68] 0 0
Alicante
Country [69] 0 0
Spain
State/province [69] 0 0
Badalona
Country [70] 0 0
Spain
State/province [70] 0 0
Barakaldo
Country [71] 0 0
Spain
State/province [71] 0 0
Barcelona
Country [72] 0 0
Spain
State/province [72] 0 0
Córdoba
Country [73] 0 0
Spain
State/province [73] 0 0
Granada
Country [74] 0 0
Spain
State/province [74] 0 0
Madrid
Country [75] 0 0
Spain
State/province [75] 0 0
Terrassa
Country [76] 0 0
Thailand
State/province [76] 0 0
Bangkok
Country [77] 0 0
Thailand
State/province [77] 0 0
Khon Kaen
Country [78] 0 0
Thailand
State/province [78] 0 0
Mueang Nonthaburi
Country [79] 0 0
Turkey
State/province [79] 0 0
Ankara
Country [80] 0 0
Turkey
State/province [80] 0 0
Istanbul
Country [81] 0 0
Turkey
State/province [81] 0 0
Trabzon
Country [82] 0 0
Ukraine
State/province [82] 0 0
Ivano-Frankivs'k
Country [83] 0 0
Ukraine
State/province [83] 0 0
Kyiv
Country [84] 0 0
Ukraine
State/province [84] 0 0
Odesa
Country [85] 0 0
Ukraine
State/province [85] 0 0
Poltava
Country [86] 0 0
Ukraine
State/province [86] 0 0
Sumy
Country [87] 0 0
Ukraine
State/province [87] 0 0
Zhytomyr

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Visterra, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Oldach, MD
Address 0 0
Visterra, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03040141