A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection
Latest Information Update: 18 Aug 2023
At a glance
- Drugs Oplunofusp (Primary)
- Indications Betacoronavirus infections; COVID 2019 infections; Enterovirus infections; Hypoxaemia; Influenza virus infections; Metapneumovirus infections; Parainfluenza virus infections
- Focus Therapeutic Use
- Acronyms STOP-Flu
- Sponsors Ansun Biopharma
- 16 Aug 2023 Results published in the Clinical Infectious Diseases
- 08 Jul 2020 Planned initiation date changed from 1 Apr 2020 to 1 Jul 2020.
- 01 Apr 2020 Planned initiation date changed from 1 Mar 2020 to 1 Apr 2020.
Most Recent Events
Trial Overview
Purpose
This is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in severe influenza in hospitalized patients.
Primary Endpoints
Percent of subjects who have returned to room air
description: Percent of subjects who have returned to room air
time_frame: 7 days
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
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
Betacoronavirus infections | treatment | - |
COVID 2019 infections | treatment | - |
Enterovirus infections | treatment | - |
Hypoxaemia | treatment | - |
Influenza virus infections | treatment | severe |
Metapneumovirus infections | treatment | - |
Parainfluenza virus infections | treatment | - |
Subjects
- Subject Type patients
-
Number
Planned: 280
- Sex male & female
- Age Group ≥ 18 years; adult
Patient Inclusion 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: 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.
Patient 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.
Trial Details
Identifiers
Identifier | Owner |
---|---|
NCT04298060 | ClinicalTrials.gov: US National Institutes of Health |
DAS181-2-07 | - |
Organisations
- Sponsors Ansun Biopharma
- Affiliations Ansun Biopharma
Trial Dates
-
Initiation Dates
Planned : 01 Jul 2020
Actual : 01 Jul 2020
-
Primary Completion Dates
Planned : 01 Mar 2021
-
End Dates
Planned : 01 Sep 2022
Other Details
- Design double-blind; multicentre; open; parallel; prospective; randomised
- Phase of Trial Phase II
- Location China
- Focus Therapeutic Use
Interventions
Drugs | Route | Formulation |
---|---|---|
OplunofuspPrimary Drug | Inhalation | Powder |
DAS181 HD group Cohort 1, Stage 1
DAS181 HD group 9mg/day for 7 or 10 days.
Drug: DAS181 (SD (4.5mg/day), HD (9mg/day))
DAS181 SD group Cohort 1, Stage 1
DAS181 SD group 4.5mg/day for 7 or 10 days
Drug: DAS181 (SD (4.5mg/day), HD (9mg/day))
DAS181 group, Cohort 1, Stage 2
DAS181 4.5mg/day or 9mg/day. Dosage will be determined after completion of stage 1.
Drug: DAS181 (SD (4.5mg/day), HD (9mg/day))
DAS181 group, Cohort 2, Stage1 and 2
DAS181 4.5mg/day or 9mg/day for 7 or 10 days
Drug: DAS181 (SD (4.5mg/day), HD (9mg/day))
Placebo, Cohort 1, Stage 1
Placebo 0mg/day for 7 or 10 days
Drug: Placebo (Placebo 0mg/day)
Placebo, Cohort 1, Stage 2
Placebo 0mg/day for 7 or 10 days
Drug: Placebo (Placebo 0mg/day)
Results
Publications
-
Mombelli M, Neofytos D, Huynh-Do U, Sanchez-Cespedes J, Stampf S, Golshayan D, et al. Immunogenicity of High-Dose vs. MF59-adjuvanted vs. Standard Influenza Vaccine in Solid Organ Transplant Recipients: The STOP-FLU trial. . Clin-Infect-Dis 2023;.
PubMed | CrossRef Fulltext
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Ivy Fan
+86 186 2190 9313
show details
ifan@ansunbiopharma.com |
, Ansun Biopharma, Inc. |
-
|
Jennifer Ho, MD, PhD | Ansun Biopharma, Inc. |
-
|
Sylvie Lu-Hinh
858-452-2631 Ext: 199
show details
slu-hinh@ansunbiopharma.com |
, Ansun Biopharma, Inc. |
-
|
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
- |
-
|
-
|
Ansun Biopharma, Inc. |
-
|
-
|
Ansun Biopharma, Inc. |
-
|
-
|
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | China |
Trial History
Event Date | Event Type | Comment |
---|---|---|
16 Aug 2023 | Results | Results published in the Clinical Infectious Diseases Updated 18 Aug 2023 |
05 Sep 2022 | Other trial event | According to ClinicalTrials.gov, the recruitment status of this study is unknown because the information has not been verified recently (last verified July 2020). Updated 05 Sep 2022 |
05 Sep 2022 | Other trial event | Last checked against the ClinicalTrials.gov record. Updated 05 Sep 2022 |
08 Jul 2020 | Other trial event | Planned initiation date changed from 1 Apr 2020 to 1 Jul 2020. Updated 13 Jul 2020 |
01 Apr 2020 | Other trial event | Planned initiation date changed from 1 Mar 2020 to 1 Apr 2020. Updated 06 Apr 2020 |
11 Mar 2020 | Other trial event | New source identified and integrated (ClinicalTrial.gov: NCT04298060) Updated 11 Mar 2020 |
04 Mar 2020 | Status change - not yet recruiting | Status changed from planning to not yet recruiting. Updated 11 Mar 2020 |
07 Nov 2019 | New trial record | New trial record Updated 07 Nov 2019 |
28 Oct 2019 | Other trial event | According to a Ansun Biopharma media release the company has raised almost $165,000,000 in the last eighteen months in order to support and fund both the STOP PIV clinical trial and the STOP FLU clinical trial in parallel. Updated 07 Nov 2019 |
28 Oct 2019 | Other trial event | According to a Ansun Biopharma media release, National Medical Products Administration has approved the Investigational New Drug Application to conduct this trial. Updated 07 Nov 2019 |
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Mombelli M, Neofytos D, Huynh-Do U, Sanchez-Cespedes J, Stampf S, Golshayan D, et al. Immunogenicity of High-Dose vs. MF59-adjuvanted vs. Standard Influenza Vaccine in Solid Organ Transplant Recipients: The STOP-FLU trial. . Clin-Infect-Dis 2023;.
PubMed | CrossRef Fulltext -
Ansun Biopharma. China's NMPA Approves Two Separate INDs On The Same Day For Ansun's Investigational Biologic Compound DAS181. Media-Rel 2019;.
Media Release
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