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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Lower Respiratory Tract Infection, Parainfluenza, Immunocompromised, COVID-19

In brief

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.

Key facts

Study ID: NCT03808922
Run by: Ansun Biopharma, Inc.
People needed: 274
Starts: 2019-05-23
Expected to finish: 2028-09-01
Last updated by the study team: 2026-06-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
For COVID-19 sub study:
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

You may not qualify if…

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
For COVID-19 sub study:
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

Where it is running

City of Hope cancer Center — Duarte, California, United States (enrolling)
University of California Davis Health System — Sacramento, California, United States (enrolling)
Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
University of Iowa Health Care — Iowa City, Iowa, United States (enrolling)
University of Kansas Medical Center — Fairway, Kansas, United States (enrolling)
University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (enrolling)
University of Pittsburgh Medical Center Health System — Pittsburgh, Pennsylvania, United States (enrolling)
UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
Baylor College of Medicine — Houston, Texas, United States (enrolling)
MD Anderson — Houston, Texas, United States (enrolling)
VCU Health System — Richmond, Virginia, United States (enrolling)
Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
Fred Hutchinson Cancer Research Center — Seattle, Washington, United States (enrolling)
Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
Mayo Clinic Rochester — Rochester, Minnesota, United States (enrolling)
Weill Cornell Medical College — New York, New York, United States (enrolling)
Duke University — Durham, North Carolina, United States (enrolling)
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
The Johns Hopkins Hospital — Baltimore, Maryland, United States
Samsung Medical Center — Seoul, Gyeonggi-do, South Korea
National Cheng Kung University Hospital — Tainan, Tainan, Taiwan
Washington University — St Louis, Missouri, United States
Froedtert Medical College Pulmonary Clinic — Milwaukee, Wisconsin, United States
Westmead Hospital — Sydney, New South Wales, Australia

Full record on ClinicalTrials.gov

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