Influenza Infection Clinical Trial
Official title:
A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection
This is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in IFV infection. An approximate total of 280 subjects will be enrolled into this study.
Cohort 1: It is designed as a two stage, multi-center, randomized, double-blind, two parallel
doses, placebo-controlled study that will investigate the efficacy of DAS181 for the
treatment of serious IFV in hospitalized patients who suffered from acute hypoxemia requiring
supplemental oxygen therapy.
Cohort 2: It is designed as an open-label study that will investigate the efficacy of DAS181
for the treatment of patients with sever IFV but not eligible for Cohort 1 and non-IFV SAD
viral infection, e.g. parainfluenza virus, human metapneumovirus, enterovirus and all strains
of β-coronaviruses (including but not limited to SARS-CoV-2), with hypoxemia requiring
supplemental oxygen therapy.
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