Home
Clinical Trials
NCT03040141

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

Last Updated: 2022-12-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-03

Study Completion Date

2018-11-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza A

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

VIS410 low dose

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

Group Type EXPERIMENTAL

Low dose of VIS410

Intervention Type DRUG

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

VIS410 high dose

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

Group Type EXPERIMENTAL

High dose of VIS410

Intervention Type DRUG

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

Placebo

Single intravenous infusion of placebo in addition to oseltamivir

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single intravenous infusion of placebo in addition to oseltamivir

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low dose of VIS410

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

Intervention Type DRUG

High dose of VIS410

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

Intervention Type DRUG

Placebo

Single intravenous infusion of placebo in addition to oseltamivir

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

oseltamivir oseltamivir oseltamivir

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Oldach, MD

Role: PRINCIPAL_INVESTIGATOR

Visterra, Inc.

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VIS410-203

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

VIS410 low dose

Low dose of VIS410

VIS410 high dose

High dose of VIS410

Placebo

Placebo

Interventions

Low dose of VIS410

High dose of VIS410

Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Visterra, Inc.

Responsible Party

Principal Investigators

David Oldach, MD

Locations

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra

Visterra