A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

Investigator: Howard Huang, MD

Study Coordinator: Darrel Cleere

Status: Open Not Enrolling

ClinicalTrials.gov Number: NCT03808922

Phone: 713.441.6232

Protocol Number: PRO00035554

Description

This is a multi-center, randomized, placebo vs investigational drug - Phase III study to investigate the effectiveness and safety of DAS181 for the treatment of immunocompromised subjects diagnosed with lower respiratory tract infection (LRTI) due to a sialic-acid dependent respiratory virus (SAD-RV), with particular emphasis on parainfluenza (PIV). The population of interest (PoI) for this study is defined as: Immunocompromised subjects diagnosed with a lower respiratory tract infection due to a SAD-RV who require supplemental oxygen =2 LPM at the time of randomization due to hypoxemia. Each adult subject will receive 4.5 mg DAS181 or placebo daily for either 7 or 10 consecutive days for a total up to 31.5 mg or 45 mg. All treatments will be administered at either an inpatient or outpatient investigational site. After the treatment period has completed, subjects will continue to be followed until Day 35.
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