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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03808922
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : June 6, 2022
Sponsor:
Information provided by (Responsible Party):
Ansun Biopharma, Inc.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lower Respiratory Tract Infection Parainfluenza Immunocompromised COVID-19 Drug: DAS181 Drug: Placebo Drug: DAS181 COVID-19 Drug: DAS181 OL Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 23, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/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


Outcome Measures
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Primary Outcome Measures :
  1. Percent of subjects who Return to Room Air (RTRA) (main study) [ Time Frame: by Day 28 ]
    Removal of all oxygen support (with stable SpO2)

  2. Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study) [ Time Frame: Day 14 ]

Secondary Outcome Measures :
  1. All-cause mortality rate (main study) [ Time Frame: at Day 28 ]
  2. Percent of subjects who Return to Room Air (RTRA) (main study) [ Time Frame: by Day 21 ]
  3. Time (in days) to RTRA (main study) [ Time Frame: Days 10, 14, 21, 28 ]
  4. Percent of subjects who achieve clinical stability (main study) [ Time Frame: by Day 28 ]
  5. Percent of subjects discharged (without mortality and hospice) (main study) [ Time Frame: by Days 14, 21, 28 and 35 ]
  6. Time (in days) to first hospital discharge (without hospice) (main study) [ Time Frame: through Day 35 ]
  7. Total number of inpatient days (main study) [ Time Frame: up to Day 35 ]
  8. Baseline SAD-RV infection-related mortality rate (main study) [ Time Frame: at Day 28 ]
  9. Baseline SAD-RV infection-related mortality rate (main study) [ Time Frame: at Day 35 ]
  10. All-cause mortality rate (main study) [ Time Frame: at Day 35 ]
  11. Change in pulmonary function (FEV1% predicted) (main study) [ Time Frame: Day 1, Day 7, Day 14, Day 28 ]
  12. Time to improved COVID19 clinical status (Sub-study) [ Time Frame: Day 5, Day 10, Day 21, Day 28 ]
  13. Time to RTRA [ Time Frame: Day 10, Day 14, Day 21, Day 28 ]
  14. Time to Clinical stability [ Time Frame: Day 14, Day 21, Day 28 ]
  15. Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable [ Time Frame: Day 5, Day 10, Day 14, Day 21, Day 28 ]
  16. Time to Clinical deterioration [ Time Frame: Day 5, Day 10, Day 14, Day 21, Day 28 ]
  17. Time to Discharge from hospital (without readmission before Day 28). [ Time Frame: Day 14, Day 21, Day 28 ]
  18. Time to Death (all causes) [ Time Frame: Day 14, Day 21, Day 28 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808922


Contacts
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Contact: Tracy Nguyen 858-452-2631 tnguyen@ansunbiopharma.com
Contact: Dylan Donn (858) 452-2631 ddonn@ansunbiopharma.com

Locations
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Sponsors and Collaborators
Ansun Biopharma, Inc.
Investigators
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Study Director: Jennifer Ho, MD Ansun Biopharma, Inc.
More Information
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Responsible Party: Ansun Biopharma, Inc.
ClinicalTrials.gov Identifier: NCT03808922    
Other Study ID Numbers: DAS181-3-01
2018-004318-16 ( EudraCT Number )
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ansun Biopharma, Inc.:
Parainfluenza
PIV
Immunocompromised
Lower Respiratory Tract Infection
LRTI
 COVID19
SARS-CoV-2
Coronavirus
Ansun
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Respiratory Tract Infections
Paramyxoviridae Infections
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Pneumonia
 Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Mononegavirales Infections