Influenza Infection, SAD-RV Infection and COVID-19
Conditions
Keywords
Severe hospitalized influenza, Lower Respiratory Tract Disease, Acute Hypoxemia, DAS181, Ansun, infection
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.
Interventions
DRUGDAS181
SD (4.5mg/day), HD (9mg/day)
DRUGPlacebo
Placebo 0mg/day
Sponsors
Ansun Biopharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Stage 2, Ansun will know the dosage.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
of Cohort 1 #4 is adapted from the Flu guideline in China (2018) and community acquired pneumonia (CAP) guideline in China (2016) Cohort 1: Subjects must meet all of the following inclusion criteria at the time of randomization to be eligible for participation in this study: 1. Males and Females ≥18 years old 2. Diagnosed as influenza (IFV) infection within 3 days before randomization 3. Requires, at the time of randomization, supplemental oxygen ≥2 LPM due to hypoxemia 4. Subjects are severely ill 5. In the opinion of investigator, subjects will be hospitalized at least 1 week. 6. If female, subject must not be pregnant or nursing Cohort 2: Subjects must meet all of the following inclusion criteria at the time of randomization to be eligible for participation in this study: 1. Males and Females ≥18 years old 2. Hypoxemia 3. Subjects fulfill one of the following conditions: 1. IFV subjects who are eligible for all inclusion criteria of Cohort 1 except for acute hypoxemia at enrollment. 2. Subjects confirmed with non-IFV SAD viral infection. 4. Same in inclusion criteria #5 to #8 in Cohort 1.
Exclusion criteria
Cohort 1 and 2: Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of subjects who have returned to room air | 7 days | Percent of subjects who have returned to room air |
| Percent change of subjects return to baseline oxygen requirement | 7 days | Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1 |
Countries
China
Contacts
Primary ContactIvy Fan
Backup ContactSylvie Lu-Hinh
Outcome results
None listed