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

NCT03040141 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2022-12-28

Study results available
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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

Interventions

DRUG

Low dose of VIS410

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

DRUG

High dose of VIS410

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

DRUG

Placebo

Single intravenous infusion of placebo in addition to oseltamivir

Sponsors & Collaborators

  • Visterra, Inc.

    lead INDUSTRY

Principal Investigators

  • David Oldach, MD · Visterra, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-03
Primary Completion
2018-11-22
Completion
2018-11-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belarus
  • Belgium
  • Bulgaria
  • Canada
  • Estonia
  • France
  • Georgia
  • Latvia
  • Malaysia
  • New Zealand
  • Russia
  • Serbia
  • Singapore
  • South Africa
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03040141 on ClinicalTrials.gov