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

NCT03040141 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: VIS410-203
• Study Type: interventional
• Target: 89
• Locations: 18 countries
• Sites: 103

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.

Conditions

Influenza A

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  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%

  Baseline to Day 56

• Time to Cessation of Oxygen Support for Any Patient Requiring Supplemental Oxygen Therapy

  Baseline to Day 56

• Viral Titer in Upper Respiratory Samples by qRT-PCR

  Day 14

• Viral Nasopharyngeal AUC

  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

  Day 1 Predose, Day 1 End of Infusion, Day 3, Day 5, Day 7

Study Arms (3)

VIS410 low dose

EXPERIMENTAL

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

Drug: Low dose of VIS410

VIS410 high dose

EXPERIMENTAL

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

Drug: High dose of VIS410

Placebo

PLACEBO COMPARATOR

Single intravenous infusion of placebo in addition to oseltamivir

Drug: Placebo

Interventions

Low dose of VIS410 DRUG

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

Also known as: oseltamivir

VIS410 low dose

High dose of VIS410 DRUG

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

Also known as: oseltamivir

VIS410 high dose

Placebo DRUG

Single intravenous infusion of placebo in addition to oseltamivir

Also known as: oseltamivir

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Visterra, Inc.: lead

Study Sites (114)

Visterra

Tucson, Arizona, 85724, United States

Location

Visterra

Stanford, California, 94305, United States

Location

Visterra

St. Petersburg, Florida, 33713, United States

Location

Visterra

Atlanta, Georgia, 30342, United States

Location

Visterra

Decatur, Georgia, 30033, United States

Location

Visterra

Blackfoot, Idaho, 83221, United States

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Visterra

Chicago, Illinois, 60637, United States

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Visterra

Detroit, Michigan, 48202, United States

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Visterra

Butte, Montana, 59701, United States

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Visterra

Albany, New York, 12208, United States

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Visterra

Syracuse, New York, 13210, United States

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Visterra

Durham, North Carolina, 27710, United States

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Visterra

Greensboro, North Carolina, 27403, United States

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Visterra

Cleveland, Ohio, 44195, United States

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Visterra

Columbus, Ohio, 43215, United States

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Visterra

Allentown, Pennsylvania, 18103, United States

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Visterra

Philadelphia, Pennsylvania, 19141, United States

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Visterra

York, Pennsylvania, 17405, United States

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Visterra

Roanoke, Virginia, 24014, United States

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Visterra

Richland, Washington, 99352, United States

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Visterra

Tacoma, Washington, 98405, United States

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Visterra

Adelaide, South Australia, 5000, Australia

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Visterra

Melbourne, 3168, Australia

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Visterra

Parkville, 3050, Australia

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Visterra

South Brisbane, 4101, Australia

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Visterra

Westmead, 2145, Australia

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Visterra

Woolloongabba, 4102, Australia

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Visterra

Brest, 224027, Belarus

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Visterra

Grodno, 230017, Belarus

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Visterra

Grodno, 230030, Belarus

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Visterra

Homyel, 246029, Belarus

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Visterra

Homyel, 246044, Belarus

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Visterra

Lesnoy, 223041, Belarus

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Visterra

Minsk, 220024, Belarus

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Visterra

Vitebsk, 210009, Belarus

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Visterra

Brussels, 1070, Belgium

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Visterra

Edegem, 2650, Belgium

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Visterra

Kozloduy, 3320, Bulgaria

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Visterra

Montana, 3400, Bulgaria

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Visterra

Plovdiv, 4002, Bulgaria

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Visterra

Sofia, 1233, Bulgaria

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Visterra

Sofia, 1431, Bulgaria

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Visterra

Sofia, 1606, Bulgaria

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Visterra

Veliko Tarnovo, 5000, Bulgaria

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Visterra

Moncton, New Brunswick, E1C 6Z8, Canada

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Visterra

Pärnu, 80010, Estonia

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Visterra

Tallinn, 10138, Estonia

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Visterra

Tallinn, 10617, Estonia

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Visterra

Tallinn, 113419, Estonia

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Visterra

Tartu, 51014, Estonia

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Visterra

La Roche-sur-Yon, 85000, France

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Visterra

La Tronche, 38700, France

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Visterra

Limoges, 87000, France

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Visterra

Metz-Tessy, 74370, France

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Visterra

Nantes, 44000, France

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Visterra

Paris, 75014, France

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Visterra

Paris, 75018, France

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Visterra

Quimper, 29000, France

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Visterra

Tbilisi, 0144, Georgia

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Visterra

Tbilisi, 0159, Georgia

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Visterra

Tbilisi, 0160, Georgia

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Visterra

Daugavpils, LV5417, Latvia

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Visterra

Liepāja, LV3414, Latvia

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Visterra

Rēzekne, LV4600, Latvia

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Visterra

Riga, LV 1002, Latvia

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Visterra

Valmiera, LV4201, Latvia

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Visterra

Ventspils, LV3601, Latvia

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Visterra

Alor Star, Kedah, 05350, Malaysia

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Visterra

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

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Visterra

Taiping, Perak, 34000, Malaysia

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Visterra

Auckland, 1023, New Zealand

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Visterra

Auckland, 2025, New Zealand

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Visterra

Wellington, 6021, New Zealand

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Visterra

Arkhangelsk, 163045, Russia

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Visterra

Kazan', 420140, Russia

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Visterra

Novosibirsk, 630051, Russia

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Visterra

Smolensk, 214006, Russia

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Visterra

Tomsk, 634063, Russia

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Visterra

Vladimir, 600023, Russia

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Visterra

Kragujevac, 34000, Serbia

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Visterra

Niš, 18000, Serbia

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Visterra

Novi Sad, 21000, Serbia

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Visterra

Singapore, 119228, Singapore

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Visterra

Singapore, 308433, Singapore

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Visterra

Lyttelton, Centurion, 0157, South Africa

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Visterra

Auckland Park, Gauteng, 2006, South Africa

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Visterra

Pretoria, Gauteng, 0002, South Africa

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Visterra

Thabazimbi, Limpopo, 0380, South Africa

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Visterra

Benoni, 1501, South Africa

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Visterra

Cape Town, 7570, South Africa

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Visterra

Durban, 4092, South Africa

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Visterra

Worcester, 6850, South Africa

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Visterra

Alicante, 03010, Spain

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Visterra

Badalona, 08916, Spain

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Visterra

Barakaldo, 48903, Spain

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Visterra

Barcelona, 08035, Spain

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Visterra

Córdoba, 14004, Spain

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Visterra

Granada, 18016, Spain

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Visterra

Madrid, 28007, Spain

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Visterra

Madrid, 28046, Spain

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Visterra

Terrassa, 08221, Spain

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Visterra

Bangkok, 10110, Thailand

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Visterra

Khon Kaen, 40002, Thailand

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Visterra

Nonthaburi, 11000, Thailand

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Visterra

Ankara, 06230, Turkey (Türkiye)

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Visterra

Istanbul, 34098, Turkey (Türkiye)

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Visterra

Trabzon, 61080, Turkey (Türkiye)

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Visterra

Ivano-Frankivsk, 76008, Ukraine

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Visterra

Kyiv, 01133, Ukraine

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Visterra

Kyiv, 04112, Ukraine

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Visterra

Odesa, 65023, Ukraine

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Visterra

Poltava, 36038, Ukraine

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Visterra

Sumy, 40021, Ukraine

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Visterra

Zhytomyr, 10002, Ukraine

Location

MeSH Terms

Interventions

Oseltamivir

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

Approximately 120 participants were planned to be included in the study. A total of 89 participants were randomized to treatment of which 73 subjects completed the trial.

Results Point of Contact

• Title: Head of Regulatory Affairs
• Organization: Visterra Inc.

info@visterrainc.com

+1 617-498-1070

Study Officials

• David Oldach, MD

  Visterra, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: February 2, 2017
• Study Start: January 3, 2018
• Primary Completion: November 22, 2018
• Study Completion: November 22, 2018
• Last Updated: December 28, 2022
• Results First Posted: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (8); CA (1); NZ (3); ZA (8); ES (5); TU (3); US (21); UA (7); AU (6); TH (3); LA (6); SG (2); RU (6); FR (8); MY (3); SE (3); BU (7); GE (3)