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A Study of Vapendavir Treatment of Hematopoietic Stem Cell Transplant Subjects With Symptomatic Rhinovirus Infection

Upper Respiratory Tract Infection Clinical Trial

Official title:
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Vapendavir Treatment of Hematopoietic Stem Cell Transplant Subjects With Symptomatic Rhinovirus Infection

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled study of vapendavir treatment of laboratory-confirmed and symptomatic HRV infection of the upper respiratory tract in allogeneic and autologous stem cell transplant subjects. The aim of this study is to evaluate the effect of vapendavir on laboratory-confirmed HRV upper-respiratory tract infection in HSCT patients, as measured by viral load changes, worsening of upper respiratory tract infection (URTI) to lower respiratory tract infection (LRTI), duration of clinical symptoms, the occurrence of supplemental oxygen use, duration of viral shedding, hospital admission and duration of hospitalization, incidence of secondary bacterial infection, and mortality rates. Additionally, the safety and tolerability of vapendavir, and the vapendavir plasma levels achieved in the HSCT population, and the profile of viral resistance development will also be assessed.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03024177
Study type Interventional
Source Vaxart
Contact
Status Withdrawn
Phase Phase 2
View Details
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