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A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

Trial Profile

A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Jun 2020

At a glance

  • Drugs DAS 181 (Primary)
  • Indications COVID 2019 infections; Parainfluenza virus infections
  • Focus Registrational; Therapeutic Use
  • Acronyms RCT; STOP PIV
  • Sponsors Ansun Biopharma
  • Most Recent Events

    • 26 Mar 2020 Patients with COVID -2019 infection were taken additionally to study effect of study drug on COVID-2019 infected patients. No. of arms were changed from 2 to 4. Substudy added in the trial
    • 26 Mar 2020 Planned number of patients changed from 132 to 250.
    • 28 Oct 2019 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.

Trial Overview

Purpose

This phase III study is designed to examine the efficacy and safety of DAS181 for the treatment of lower respiratory tract parainfluenza infection in immunocompromised subjects.

Primary Endpoints

Percent of subjects who Return to Room Air (RTRA) (main study)

description: Removal of all oxygen support (with stable SpO2)
time_frame: by Day 28

Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)

time_frame: Day 14

Other Endpoints

All-cause mortality rate (main study)

time_frame: at Day 28
time_frame: at Day 35

Percent of subjects who Return to Room Air (RTRA) (main study)

time_frame: by Day 21

Time (in days) to RTRA (main study)

time_frame: Days 10, 14, 21, 28

Percent of subjects who achieve clinical stability (main study)

time_frame: by Day 28

Percent of subjects discharged (without mortality and hospice) (main study)

time_frame: by Days 14, 21, 28 and 35

Time (in days) to first hospital discharge (without hospice) (main study)

time_frame: through Day 35

Total number of inpatient days (main study)

time_frame: up to Day 35

Baseline SAD-RV infection-related mortality rate (main study)

time_frame: at Day 28
time_frame: at Day 35

Change in pulmonary function (FEV1% predicted) (main study)

time_frame: Day 1, Day 7, Day 14, Day 28

Time to improved COVID19 clinical status (Sub-study)

time_frame: Day 5, Day 10, Day 21, Day 28

Time to RTRA

time_frame: Day 10, Day 14, Day 21, Day 28

Time to Clinical stability

time_frame: Day 14, Day 21, Day 28

Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable

time_frame: Day 5, Day 10, Day 14, Day 21, Day 28

Time to Clinical deterioration

time_frame: Day 5, Day 10, Day 14, Day 21, Day 28

Time to Discharge from hospital (without readmission before Day 28).

time_frame: Day 14, Day 21, Day 28

Time to Death (all causes)

time_frame: Day 14, Day 21, Day 28 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Parainfluenza virus infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 250

  • Sex male & female
  • Age Group adolescent; adult; child; infant; neonate

Patient Inclusion Criteria

1. At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia. 2. Immunocompromised, as defined by one or more of the following: - Received an autologous or allogeneic hematopoietic stem cell transplantation (HSCT) at any time in the past - Received a solid organ transplant at any time in the past - Has been or is currently being treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past - Has an immunodeficiency due to congenital abnormality (only applicable to subjects age < 18 years old) or pre-term birth (only applicable to subjects age ≤ 2 years old) 3. Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid dependent respiratory virus 4. If female, subject must meet one of the following conditions: - Not be of childbearing potential or - Be of childbearing potential and have a negative urine/serum pregnancy test and agrees to practice an acceptable method of contraception 5. Non-vasectomized males are required to practice effective birth control methods 6. Capable of understanding and complying with procedures as outlined in the protocol 7. Provides signed informed consent prior to the initiation of any screening or study-specific procedures For COVID-19 sub study: 1. Be ≥18 years of age 2. Provide adequate medical history to permit accurate stratification (but health status may be healthy, high-risk conditions, or immunocompromised). 3. Prior to SARS CoV 2 infection, has the ability to carry out self-care activities of daily living (basic ADL) 4. Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with or without contrast, to involve at least 2 lobes of the lung. 5. Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tract by at least one of the following samples 6. Satisfy inclusion criteria #1, 4, 5, 6, 7 of the main study

Patient Exclusion Criteria

1. Subjects may not be on hospice care or, in the opinion of the investigator, have a low chance of survival during the first 10 days of treatment 2. Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2x ULN Note: Subjects with ALT/AST/ALP ≥ 3x ULN AND TB ≥2x ULN that have been chronically stable (for >1 year on more than one assessments) due to known liver pathology including malignancy (primary or metastasis), chronic medications, transplantation, or chronic infection will not be excluded 3. Female subjects breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug 4. Subjects taking any other investigational drug used to treat pulmonary infection. 5. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance 6. Subjects with known hypersensitivity to DAS181 and/or any of its components 7. Subjects with severe sepsis due to either their baseline SAD-RV infection or a concurrent viral, bacterial, or fungal infection and meet at least one of the following criteria: - Has evidence of vital organ failure outside of the lung (e.g., liver, kidney) - Requires vasopressors to maintain blood pressure For COVID-19 sub study: 1. Subjects requiring invasive mechanical, Bi-PAP or CPAP ventilation at randomization. 2. Subjects receiving any other investigational or empiric treatment for SARS-2-CoV (either as part of a clinical trial or under emergency approval (approved agents for the management of symptoms, e.g., fever, are permitted). 3. Subjects who are known HIV-positive (and not undetectable at most recent HIV RNA assessment) 4. Subjects who are currently taking immunomodulating biologics (e.g, interferons, interleukin) 5. Subjects with severe sepsis due to either their SARS-CoV-2 infection or a concurrent viral, bacterial, or fungal infection and meeting at least one of the following criteria: - Have evidence of vital organ failure outside of the lung (e.g., liver, kidney) - Require vasopressors to maintain blood pressure 6. Subjects meeting exclusion criteria #2, 3, 5 and 6 of the main study

Trial Details

Identifiers

Identifier Owner
NCT03808922 ClinicalTrials.gov: US National Institutes of Health
EudraCT2018-004318-16 European Clinical Trials Database
DAS181-3-01 -

Organisations

  • Sponsors Ansun Biopharma
  • Affiliations Ansun Biopharma

Trial Dates

  • Initiation Dates

    Planned : 28 Mar 2019

    Actual : 23 May 2019

  • Primary Completion Dates

    Planned : 30 Apr 2021

  • End Dates

    Planned : 28 Dec 2021

Substudies/Extensions

1. Main/Parent Optional Pharmacokinetics Sub-Study Information Sheet and Consent Form, version 2.0 dated 21Feb2019. 2. Pediatric Pharmacokinetic Sub-Study Assent Form (12&NDASH;17 Years Old) Assent of a Minor to Be in an Investigational Study, version 2.0 dated 21Feb2019. Objective is to investigate how the study drug is processed by the body by checking how much of the study drug is in the bloodstream at a particular point in time.

Patients with Severe COVID-19

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location Asia; Australia; Belgium; China; Denmark; Europe; France; Germany; Hong Kong; Italy; South Korea; Spain; Taiwan; USA
  • Focus Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
DAS 181Primary Drug Inhalation Solution

DAS181

DAS181 4.5mg qd x 7 OR 10 days Drug: DAS181 (DAS181 4.5mg nebulized qd x 7 OR 10 days)

Placebo

Placebo qd x 7 OR 10 days Drug: Placebo (Placebo nebulized qd x 7 OR 10 days)

DAS181 COVID-19

DAS181 4.5mg q12h x 7 OR 10 days Drug: DAS181 COVID-19 (DAS181 4.5mg nebulized q12h/day x 7 OR 10 days)

DAS181 OL

DAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (< 40kg) Drug: DAS181 OL (DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days < 40kg)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Jennifer Ho, M.D
858-452-2631 Ext: 218
jho@ansunbiopharma.com
show details
, Ansun Biopharma, Inc. USA
Medical Monitor
3030 Callan Road
San Diego
Postcode: CA 92121
United States
Telephone: 858452 2631218
Fax: 858452 0133
DAS181@ansunbiopharma.com
show details
Ansun Biopharma, Inc. USA
Stanley Lewis, M.D Ansun Biopharma, Inc. USA
Sylvie Lu-Hinh, MS
858-452-2631 Ext: 199
slu-hinh@ansunbiopharma.com
show details
, Ansun Biopharma, Inc. USA

Centres

Centre Name Location Trial Centre Country
-
-
-
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois USA
Ansun Biopharma, Inc.
-
-
Ansun Biopharma, Inc.
-
-
Ansun Biopharma, Inc. San Diego USA
Asan Medical Center Songpa-gu, Seoul South-Korea
Brigham and Women's Hospital Boston, Massachusetts USA
Children's Hospital Colorado Aurora, Colorado USA
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio USA
City of Hope cancer Center Duarte, California USA
Cook Children's Fort Worth, Texas USA
Duke University Durham, North Carolina USA
Fred Hutchinson Cancer Research Center Seattle, Washington USA
Loyola University Medical Center Maywood, Illinois USA
MD Anderson Houston, Texas USA
Medical College of Wisconsin Milwaukee, Wisconsin USA
National Taiwan University Hospital Zhongzheng Dist., Taipei City Taiwan
Oregon Health & Science University Portland, Oregon USA
Peter MacCallum Cancer Centre Melbourne, Victoria Australia
Royal Melbourne Hospital Melbourne, Victoria Australia
Samsung Medical Center Gangnam-gu, Seoul South-Korea
Seattle Children's Hospital Seattle, Washington USA
Seoul National University Bundang Hospital Seongnam-si, Guenoggi-do South-Korea
Seoul National University Hospital Jongno-gu, Seoul South-Korea
The Catholic University of Korea, Seoul St. Mary's Hospital Seocho-gu, Seoul South-Korea
The Wesley Hospital Brisbane, Queensland Australia
UCLA Los Angeles, California USA
University of Chicago Chicago, Illinois USA
University of Kansas Medical Center Fairway, Kansas USA
University of Nebraska Medical Center Omaha, Nebraska USA
University of Pennsylvania Philadelphia, Pennsylvania USA
University of Pittsburgh Medical Center Health System Pittsburgh, Pennsylvania USA
Vanderbilt University Medical Center Nashville, Tennessee USA
VCU Health System Richmond, Virginia USA
Washington University Saint Louis, Missouri USA
Westmead Hospital Sydney, New South Wales Australia

Trial History

Event Date Event Type Comment
12 Jun 2020 Other trial event Last checked against Eudra record. Updated 12 Jun 2020
18 Apr 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 18 Apr 2020
26 Mar 2020 Protocol amendment Patients with COVID -2019 infection were taken additionally to study effect of study drug on COVID-2019 infected patients. No. of arms were changed from 2 to 4. Substudy added in the trial Updated 06 Apr 2020
26 Mar 2020 Other trial event Planned number of patients changed from 132 to 250. Updated 01 Apr 2020
22 Jan 2020 Other trial event New source identified and integrated (European Clinical Trials Database: EudraCT2018-004318-16). Updated 22 Jan 2020
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 an Ansun Biopharma media release, China's National Medical Products Administration has apporved Investigational New Drug Application to enroll patients in China for this study. Updated 07 Nov 2019
28 May 2019 Other trial event According to an Ansun Biopharma media release, first patient has been enrolled in this study. Updated 30 May 2019
23 May 2019 Status change - recruiting Status changed from active, no longer recruiting to recruiting. Updated 30 May 2019
21 May 2019 Status change - active, no longer recruiting Status changed from not yet recruiting to active, no longer recruiting. Updated 24 May 2019
14 Feb 2019 Other trial event Planned initiation date changed from 28 Feb 2019 to 28 Mar 2019. Updated 22 Feb 2019
23 Jan 2019 Other trial event New source identified and integrated (ClinicalTrials.gov: NCT03808922). Updated 23 Jan 2019
16 Jan 2019 Status change - not yet recruiting Status changed from planning to not yet recruiting. Updated 23 Jan 2019
11 Oct 2017 New trial record New trial record Updated 11 Oct 2017

References

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

    Available from: URL: http://clinicaltrials.gov
  2. Ansun Biopharma. Ansun Biopharma Announces First Patient Enrolled In Phase 3 Clinical Trial Evaluating DAS181 In Hospitalized, Immunocompromised Patients With Lower Respiratory Tract Parainfluenza Virus Infection. Media-Rel 2019;.

    Media Release
  3. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  4. Ansun Biopharma. Ansun BioPharma Announces Breakthrough Designation for its Experimental Drug DAS181. Media-Rel 2017;.

    Media Release
  5. 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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