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A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection

Trial Profile

A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 13 Jul 2020

At a glance

  • Drugs DAS 181 (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
  • Most Recent Events

    • 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.
    • 04 Mar 2020 Status changed from planning to not yet recruiting.

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

  • 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
DAS 181Primary 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)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Ivy Fan
+86 186 2190 9313
ifan@ansunbiopharma.com
show details
, Ansun Biopharma, Inc.
-
Jennifer Ho, MD, PhD Ansun Biopharma, Inc.
-
Sylvie Lu-Hinh
858-452-2631 Ext: 199
slu-hinh@ansunbiopharma.com
show details
, 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
13 Jul 2020 Other trial event Last checked against the ClinicalTrials.gov record. Updated 13 Jul 2020
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

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. 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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