NCT04298060

DAS181 for Patients With Severe Hospitalized Flu and SAD-RVs (COVID-19)

A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Ansun Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Influenza Infection
• SAD-RV Infection and COVID-19

Interventions

Type	Name	Description
DRUG	DAS181	SD (4.5mg/day), HD (9mg/day)
DRUG	Placebo	Placebo 0mg/day

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-03-01
• Completion: 2022-09-01
• First posted: 2020-03-06
• Last updated: 2020-07-09

Locations

1 site across 1 country: China