A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection
Overview
- Phase
- Phase 2
- Intervention
- DAS181
- Conditions
- Influenza Infection
- Sponsor
- Ansun Biopharma, Inc.
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- Percent of subjects who have returned to room air
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
DAS181 SD group Cohort 1, Stage 1
DAS181 SD group 4.5mg/day for 7 or 10 days
Intervention: DAS181
DAS181 HD group Cohort 1, Stage 1
DAS181 HD group 9mg/day for 7 or 10 days.
Intervention: DAS181
Placebo, Cohort 1, Stage 1
Placebo 0mg/day for 7 or 10 days
Intervention: Placebo
DAS181 group, Cohort 1, Stage 2
DAS181 4.5mg/day or 9mg/day. Dosage will be determined after completion of stage 1.
Intervention: DAS181
Placebo, Cohort 1, Stage 2
Placebo 0mg/day for 7 or 10 days
Intervention: Placebo
DAS181 group, Cohort 2, Stage1 and 2
DAS181 4.5mg/day or 9mg/day for 7 or 10 days
Intervention: DAS181
Outcomes
Primary Outcomes
Percent of subjects who have returned to room air
Time Frame: 7 days
Percent of subjects who have returned to room air
Percent change of subjects return to baseline oxygen requirement
Time Frame: 7 days
Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1