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.
Drug: DAS181
SD (4.5mg/day), HD (9mg/day)
Drug: Placebo
Placebo 0mg/day
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 exclusion criteria are not to be enrolled in this
study:
1. Subjects requiring mechanical, Bi-PAP or CPAP ventilation at randomization.
2. Life expectancy less than 30 days.
3. Subjects with conscious disturbance (slow response, drowsy, restlessness, anxiety,
confusion, twitching or convulsion)
4. Subjects with unstable hemodynamics such as systolic blood pressure < 90 mmHg or
septic shock
5. Subjects with BUN≧7.14 mmol/L
6. Subjects treated with inhaled anti-viral therapy and washout period ≦ 48 hours.
7. If Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) or Alkaline
Phosphatase (ALP) are ≥3x ULN and Total Bilirubin (TB) is ≥2x ULN.
8. Female subjects with positive pregnancy test result, breastfeeding or planning to
breastfeed at any time through 30 days after the last dose of study drug.
9. Subjects taking any other investigational drug used to treat for another respiratory
infection.
10. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion
of the principal investigator, would affect subject safety and/or compliance.
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
Ivy Fan
+86 186 2190 9313
ifan@ansunbiopharma.com
Sylvie Lu-Hinh
858-452-2631 - 199
slu-hinh@ansunbiopharma.com
Jennifer Ho, MD, PhD, Study Director
Ansun Biopharma, Inc.