Back to resultsDAS181 for Patients With Severe Hospitalized Flu and SAD-RVs (COVID-19) (STOP-Flu)
Primary Purpose
Influenza Infection, SAD-RV Infection and COVID-19
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
DAS181
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Influenza Infection focused on measuring Severe hospitalized influenza, Lower Respiratory Tract Disease, Acute Hypoxemia, DAS181, Ansun, infection
Eligibility Criteria
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:
- Males and Females ≥18 years old
- Diagnosed as influenza (IFV) infection within 3 days before randomization
- Requires, at the time of randomization, supplemental oxygen ≥2 LPM due to hypoxemia
- Subjects are severely ill
- In the opinion of investigator, subjects will be hospitalized at least 1 week.
- 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:
- Males and Females ≥18 years old
- Hypoxemia
Subjects fulfill one of the following conditions:
- IFV subjects who are eligible for all inclusion criteria of Cohort 1 except for acute hypoxemia at enrollment.
- Subjects confirmed with non-IFV SAD viral infection.
- 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:
- Subjects requiring mechanical, Bi-PAP or CPAP ventilation at randomization.
- Life expectancy less than 30 days.
- Subjects with conscious disturbance (slow response, drowsy, restlessness, anxiety, confusion, twitching or convulsion)
- Subjects with unstable hemodynamics such as systolic blood pressure < 90 mmHg or septic shock
- Subjects with BUN≧7.14 mmol/L
- Subjects treated with inhaled anti-viral therapy and washout period ≦ 48 hours.
- If Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) or Alkaline Phosphatase (ALP) are ≥3x ULN and Total Bilirubin (TB) is ≥2x ULN.
- 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.
- Subjects taking any other investigational drug used to treat for another respiratory infection.
- Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance.
Sites / Locations
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Arm Label
DAS181 SD group Cohort 1, Stage 1
DAS181 HD group Cohort 1, Stage 1
Placebo, Cohort 1, Stage 1
DAS181 group, Cohort 1, Stage 2
Placebo, Cohort 1, Stage 2
DAS181 group, Cohort 2, Stage1 and 2
Arm Description
DAS181 SD group 4.5mg/day for 7 or 10 days
DAS181 HD group 9mg/day for 7 or 10 days.
Placebo 0mg/day for 7 or 10 days
DAS181 4.5mg/day or 9mg/day. Dosage will be determined after completion of stage 1.
Placebo 0mg/day for 7 or 10 days
DAS181 4.5mg/day or 9mg/day for 7 or 10 days
Outcomes
Primary Outcome Measures
Percent of subjects who have returned to room air
Percent of subjects who have returned to room air
Percent change of subjects return to baseline oxygen requirement
Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04298060
Brief Title
DAS181 for Patients With Severe Hospitalized Flu and SAD-RVs (COVID-19)
Acronym
STOP-Flu
Official Title
A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ansun Biopharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Infection, SAD-RV Infection and COVID-19
Keywords
Severe hospitalized influenza, Lower Respiratory Tract Disease, Acute Hypoxemia, DAS181, Ansun, infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Stage 2, Ansun will know the dosage.
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DAS181 SD group Cohort 1, Stage 1
Arm Type
Experimental
Arm Description
DAS181 SD group 4.5mg/day for 7 or 10 days
Arm Title
DAS181 HD group Cohort 1, Stage 1
Arm Type
Experimental
Arm Description
DAS181 HD group 9mg/day for 7 or 10 days.
Arm Title
Placebo, Cohort 1, Stage 1
Arm Type
Placebo Comparator
Arm Description
Placebo 0mg/day for 7 or 10 days
Arm Title
DAS181 group, Cohort 1, Stage 2
Arm Type
Experimental
Arm Description
DAS181 4.5mg/day or 9mg/day. Dosage will be determined after completion of stage 1.
Arm Title
Placebo, Cohort 1, Stage 2
Arm Type
Placebo Comparator
Arm Description
Placebo 0mg/day for 7 or 10 days
Arm Title
DAS181 group, Cohort 2, Stage1 and 2
Arm Type
Experimental
Arm Description
DAS181 4.5mg/day or 9mg/day for 7 or 10 days
Intervention Type
Drug
Intervention Name(s)
DAS181
Intervention Description
SD (4.5mg/day), HD (9mg/day)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 0mg/day
Primary Outcome Measure Information:
Title
Percent of subjects who have returned to room air
Description
Percent of subjects who have returned to room air
Time Frame
7 days
Title
Percent change of subjects return to baseline oxygen requirement
Description
Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Males and Females ≥18 years old
Diagnosed as influenza (IFV) infection within 3 days before randomization
Requires, at the time of randomization, supplemental oxygen ≥2 LPM due to hypoxemia
Subjects are severely ill
In the opinion of investigator, subjects will be hospitalized at least 1 week.
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:
Males and Females ≥18 years old
Hypoxemia
Subjects fulfill one of the following conditions:
IFV subjects who are eligible for all inclusion criteria of Cohort 1 except for acute hypoxemia at enrollment.
Subjects confirmed with non-IFV SAD viral infection.
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:
Subjects requiring mechanical, Bi-PAP or CPAP ventilation at randomization.
Life expectancy less than 30 days.
Subjects with conscious disturbance (slow response, drowsy, restlessness, anxiety, confusion, twitching or convulsion)
Subjects with unstable hemodynamics such as systolic blood pressure < 90 mmHg or septic shock
Subjects with BUN≧7.14 mmol/L
Subjects treated with inhaled anti-viral therapy and washout period ≦ 48 hours.
If Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) or Alkaline Phosphatase (ALP) are ≥3x ULN and Total Bilirubin (TB) is ≥2x ULN.
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.
Subjects taking any other investigational drug used to treat for another respiratory infection.
Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivy Fan
Phone
+86 186 2190 9313
Email
ifan@ansunbiopharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvie Lu-Hinh
Phone
858-452-2631
Ext
199
Email
slu-hinh@ansunbiopharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Ho, MD, PhD
Organizational Affiliation
Ansun Biopharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
DAS181 for Patients With Severe Hospitalized Flu and SAD-RVs (COVID-19)
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