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Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study

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ClinicalTrials.gov Identifier: NCT03808922
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : March 25, 2021
Sponsor:
Information provided by (Responsible Party):
Ansun Biopharma, Inc.

Tracking Information
First Submitted Date  ICMJE January 16, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date March 25, 2021
Actual Study Start Date  ICMJE May 23, 2019
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
  • Percent of subjects who Return to Room Air (RTRA) (main study) [ Time Frame: by Day 28 ]
    Removal of all oxygen support (with stable SpO2)
  • Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study) [ Time Frame: Day 14 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
Percent of subjects who Return to Room Air (RTRA) [ Time Frame: 28 days ]
Removal of all oxygen support
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
  • All-cause mortality rate (main study) [ Time Frame: at Day 28 ]
  • 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 ]
  • Baseline SAD-RV infection-related mortality rate (main study) [ Time Frame: at Day 35 ]
  • All-cause mortality rate (main study) [ 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
Official Title  ICMJE 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
Brief Summary

This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection.

It also contains a sub-study to enroll patients with severe COVID-19.

Detailed Description

Eligible subjects (i.e., those meeting the Inclusion / Exclusion criteria) will be enrolled in one of four cohorts based on the following criteria:

Cohort 1:

All eligible subjects in the PoI who are ≥18 year old subjects with a PIV infection and meet all of the following criteria:

1.1 Meet criteria for being severely immunocompromised 1.2 Prior to the onset of PIV infection, had no ongoing need for oxygen therapy due to a chronic respiratory condition (e.g., COPD, sleep apnea) and are assessed as acutely hypoxemic due to their PIV infection 1.3 At the time of randomization are not on mechanical, bi-level or continuous positive airway pressure (Bi-PAP or CPAP) ventilation 1.4 Have no known concurrent respiratory viral coinfection(s)

Cohort 2:

All eligible subjects in the PoI who are ≥18 year old with a PIV infection (including those with PIV and another SAD-RV) who do not meet one or more of the listed criteria for Cohort 1.

Cohort 3:

All eligible subjects in the PoI who are <18 year old subjects with a PIV infection (including those with PIV and another concurrent SAD-RV). There is no lower age limit for this cohort.

Cohort 4:

All eligible subjects in the PoI with a respiratory infection due to any SAD-RV infection except PIV. Eligible subjects with both PIV and an additional concurrent SAD-RV, will be enrolled for either Cohorts 2 or 3 depending on their age. There is no lower age limit for this cohort.

Sub-Study:

Patients with Severe COVID-19

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Lower Respiratory Tract Infection
  • Parainfluenza
  • Immunocompromised
  • COVID-19
Intervention  ICMJE
  • Drug: DAS181
    DAS181 4.5mg nebulized qd x 7 OR 10 days
  • Drug: Placebo
    Placebo nebulized qd x 7 OR 10 days
  • Drug: DAS181 COVID-19
    DAS181 4.5mg nebulized q12h/day x 7 OR 10 days
  • 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
Study Arms  ICMJE
  • Experimental: Cohort 1 and Cohort 2 Treatment
    DAS181 4.5mg qd x 7 OR 10 days
    Intervention: Drug: DAS181
  • Placebo Comparator: Cohort 1 and Cohort 2 Placebo
    Placebo qd x 7 OR 10 days
    Intervention: Drug: Placebo
  • Experimental: Cohort 3
    DAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (< 40kg)
    Intervention: Drug: DAS181 OL
  • Experimental: Cohort 4
    DAS181 4.5mg qd x 7 OR 10 days
    Intervention: Drug: DAS181 OL
  • Experimental: DAS181 COVID-19 Treatment
    DAS181 4.5mg q12h x 7 OR 10 days
    Intervention: Drug: DAS181 COVID-19
  • Placebo Comparator: DAS181 COVID-19 Placebo
    Placebo q12h x 7 OR 10 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 17, 2021)
274
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2019)
132
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tracy Nguyen 858-452-2631 tnguyen@ansunbiopharma.com
Contact: Aeri Kim akim@ansunbiopharma.com
Listed Location Countries  ICMJE Australia,   China,   Denmark,   France,   Hong Kong,   Korea, Republic of,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03808922
Other Study ID Numbers  ICMJE DAS181-3-01
2018-004318-16 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ansun Biopharma, Inc.
Study Sponsor  ICMJE Ansun Biopharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jennifer Ho, MD Ansun Biopharma, Inc.
PRS Account Ansun Biopharma, Inc.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP