Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
NCT ID: NCT03808922
Last Updated: 2024-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
274 participants
INTERVENTIONAL
2019-05-23
2025-08-31
Brief Summary
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It also contains a sub-study to enroll patients with severe COVID-19.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1 and Cohort 2 Treatment
DAS181 4.5mg qd x 7 OR 10 days
DAS181
DAS181 4.5mg nebulized qd x 7 OR 10 days
Cohort 1 and Cohort 2 Placebo
Placebo qd x 7 OR 10 days
Placebo
Placebo nebulized qd x 7 OR 10 days
Cohort 3
DAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (\< 40kg)
DAS181 OL
DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days \< 40kg
Cohort 4
DAS181 4.5mg qd x 7 OR 10 days
DAS181 OL
DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days \< 40kg
DAS181 COVID-19 Treatment
DAS181 4.5mg q12h x 7 OR 10 days
DAS181 COVID-19
DAS181 4.5mg nebulized q12h/day x 7 OR 10 days
DAS181 COVID-19 Placebo
Placebo q12h x 7 OR 10 days
Placebo
Placebo nebulized qd x 7 OR 10 days
Interventions
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DAS181
DAS181 4.5mg nebulized qd x 7 OR 10 days
Placebo
Placebo nebulized qd x 7 OR 10 days
DAS181 COVID-19
DAS181 4.5mg nebulized q12h/day x 7 OR 10 days
DAS181 OL
DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days \< 40kg
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
ALL
No
Sponsors
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Ansun Biopharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Li
Role: STUDY_DIRECTOR
Ansun Biopharma, Inc.
Locations
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City of Hope cancer Center
Duarte, California, United States
UCLA
Los Angeles, California, United States
University of California Davis Health System
Sacramento, California, United States
University of California San Diego Medical Center
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Sylvester Comprehensive Cancer Center, University of Miami Health System
Miami, Florida, United States
Houston Methodist Hospital
Tampa, Florida, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Iowa Health Care
Iowa City, Iowa, United States
University of Kansas Medical Center
Fairway, Kansas, United States
Louisiana State University
Shreveport, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Universtiy of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Duke University
Durham, North Carolina, United States
Novant Health
Winston-Salem, North Carolina, United States
The Lindner Center- The Christ Hospital
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
St. Elizabeth Youngstown Hospital
Youngstown, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, United States
Kent Hospital
Warwick, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Cook Children's
Fort Worth, Texas, United States
Texas Health
Fort Worth, Texas, United States
Therapeutic Concepts
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
MD Anderson
Houston, Texas, United States
VCU Health System
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Froedtert Medical College Pulmonary Clinic
Milwaukee, Wisconsin, United States
Westmead Hospital
Sydney, New South Wales, Australia
The Wesley Hospital
Auchenflower, Queensland, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Shanghai Pulmonary Hospital
Yangpu, Shanghai Municipality, China
West China Hospital
Chengdu, Sichuan, China
Shulan (Hangzhou) Hospital co., LTD
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Rigshospitalet
Copenhagen, , Denmark
Hôpital Henri Mondor
Créteil, Île-de-France Region, France
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, Gyeonggi-do, South Korea
Asan Medical Center
Seoul, Gyeonggi-do, South Korea
Samsung Medical Center
Seoul, Gyeonggi-do, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Gyeonggi-do, South Korea
National Taiwan University Hospital
Zhongzheng, Taipei City, Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Stuart Cohen, MD
Role: primary
Rosypriya Kodiyanplakkal, MD
Role: primary
Cameron Wolfe, MD
Role: primary
Kristin Miller, MD
Role: primary
Jonathon Truwit, MD
Role: primary
Other Identifiers
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2018-004318-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DAS181-3-01
Identifier Type: -
Identifier Source: org_study_id
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