Share

Save

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

PHASE3RECRUITING

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.

info
Simpliy with AI

Study details:

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.

info
Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia.
  • 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)
  • Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid dependent respiratory virus
  • 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
  • Non-vasectomized males are required to practice effective birth control methods
  • Capable of understanding and complying with procedures as outlined in the protocol
  • Provides signed informed consent prior to the initiation of any screening or study-specific procedures
  • Be ≥18 years of age
  • Provide adequate medical history to permit accurate stratification (but health status may be healthy, high-risk conditions, or immunocompromised).
  • Prior to SARS CoV 2 infection, has the ability to carry out self-care activities of daily living (basic ADL)
  • Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with or without contrast, to involve at least 2 lobes of the lung.
  • Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tract by at least one of the following samples
  • Satisfy inclusion criteria #1, 4, 5, 6, 7 of the main study

    • Exclusion criteria

  • 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
  • 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
  • Female subjects 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 pulmonary 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
  • Subjects with known hypersensitivity to DAS181 and/or any of its components
  • 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
  • Subjects requiring invasive mechanical, Bi-PAP or CPAP ventilation at randomization.
  • 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).
  • Subjects who are known HIV-positive (and not undetectable at most recent HIV RNA assessment)
  • Subjects who are currently taking immunomodulating biologics (e.g, interferons, interleukin)
  • 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
  • Subjects meeting exclusion criteria #2, 3, 5 and 6 of the main study
    • info
    Simplify with AI

    Eligibility

    Age eligible for study : 0 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2019-05-23

    Primary completion: 2024-12-31

    Study completion finish: 2024-12-31

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT03808922

    Intervention or treatment

    DRUG: DAS181

    DRUG: Placebo

    DRUG: DAS181 COVID-19

    DRUG: DAS181 OL

    Conditions

    • • COVID-19
    • • Lower Respiratory Tract Infection
    • • Parainfluenza
    • • Immunocompromised
    Image related to COVID-19

    • Condition: COVID-19, Lower Respiratory Tract Infection and more

    • DRUG: DAS181 and other drugs

    • Sydney, New South Wales, Australia and more

    • Sponsor: Ansun Biopharma, Inc.

    You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

    Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

    Find a site

    Closest Location:

    Westmead Hospital

    Research sites nearby

    Select from list below to view details:

    • Westmead Hospital

      Sydney, New South Wales, Australia

    • The Wesley Hospital

      Auchenflower, Queensland, Australia

    • Royal Melbourne Hospital

      Melbourne, Victoria, Australia

    • Peter MacCallum Cancer Centre

      Melbourne, Victoria, Australia

    Loading...

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Cohort 1 and Cohort 2 Treatment
    • DAS181 4.5mg qd x 7 OR 10 days
    DRUG: DAS181
    • DAS181 4.5mg nebulized qd x 7 OR 10 days
    PLACEBO_COMPARATOR: Cohort 1 and Cohort 2 Placebo
    • Placebo qd x 7 OR 10 days
    DRUG: Placebo
    • Placebo nebulized qd x 7 OR 10 days
    EXPERIMENTAL: Cohort 3
    • 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
    EXPERIMENTAL: Cohort 4
    • DAS181 4.5mg qd 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
    EXPERIMENTAL: DAS181 COVID-19 Treatment
    • DAS181 4.5mg q12h x 7 OR 10 days
    DRUG: DAS181 COVID-19
    • DAS181 4.5mg nebulized q12h/day x 7 OR 10 days
    PLACEBO_COMPARATOR: DAS181 COVID-19 Placebo
    • Placebo q12h x 7 OR 10 days
    DRUG: Placebo
    • Placebo nebulized qd x 7 OR 10 days

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Percent of subjects who Return to Room Air (RTRA) (main study)Removal of all oxygen support (with stable SpO2)by Day 28
    Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)Not SpecifiedDay 14

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    All-cause mortality rate (main study)Not Specifiedat Day 28
    Percent of subjects who Return to Room Air (RTRA) (main study)Not Specifiedby Day 21
    Time (in days) to RTRA (main study)Not SpecifiedDays 10, 14, 21, 28
    Percent of subjects who achieve clinical stability (main study)Not Specifiedby Day 28
    Percent of subjects discharged (without mortality and hospice) (main study)Not Specifiedby Days 14, 21, 28 and 35
    Time (in days) to first hospital discharge (without hospice) (main study)Not Specifiedthrough Day 35
    Total number of inpatient days (main study)Not Specifiedup to Day 35
    Baseline SAD-RV infection-related mortality rate (main study)Not Specifiedat Day 28
    Baseline SAD-RV infection-related mortality rate (main study)Not Specifiedat Day 35
    All-cause mortality rate (main study)Not Specifiedat Day 35
    Change in pulmonary function (FEV1% predicted) (main study)Not SpecifiedDay 1, Day 7, Day 14, Day 28
    Time to improved COVID19 clinical status (Sub-study)Not SpecifiedDay 5, Day 10, Day 21, Day 28
    Time to RTRANot SpecifiedDay 10, Day 14, Day 21, Day 28
    Time to Clinical stabilityNot SpecifiedDay 14, Day 21, Day 28
    Time to SARS-CoV-2 RNA in the respiratory specimens being undetectableNot SpecifiedDay 5, Day 10, Day 14, Day 21, Day 28
    Time to Clinical deteriorationNot SpecifiedDay 5, Day 10, Day 14, Day 21, Day 28
    Time to Discharge from hospital (without readmission before Day 28).Not SpecifiedDay 14, Day 21, Day 28
    Time to Death (all causes)Not SpecifiedDay 14, Day 21, Day 28

    Frequently Asked Questions

    Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

    No questions submitted. Be the first to ask a question!

    You may be eligible to participate in this trial based on your search.Apply for study
    Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

    References

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

    Other trails to consider

    Top searched conditions

    ABN: 29 640 485 105 © 2025 Clinrol