New hope for immunocompromised patients with severe parainfluenza

NCT ID NCT03808922

Disease control Sponsor: Ansun Biopharma, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called DAS181 in people with weakened immune systems who have a serious lung infection caused by parainfluenza virus. The goal is to see if the drug helps them breathe without extra oxygen and reduces the risk of death. About 274 participants will receive either DAS181 or a placebo, and the study also includes a smaller group of patients with severe COVID-19.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 274 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2019

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease COVID-19 immunodeficiency disease lower respiratory tract disorder parainfluenza infectious disease Paramyxoviridae infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID -19 Immunocompromised Lower respiratory tract infection Parainfluenza

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

19 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING

Chicago, Illinois, 60611, United States
Baylor College of Medicine
RECRUITING

Houston, Texas, 77030, United States
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Cincinnati Children's Hospital Medical Center
RECRUITING

Cincinnati, Ohio, 45267, United States
City of Hope cancer Center
RECRUITING

Duarte, California, 91010, United States
Duke University
RECRUITING

Durham, North Carolina, 27710, United States
Fred Hutchinson Cancer Center
RECRUITING

Seattle, Washington, 98109, United States
Fred Hutchinson Cancer Research Center
RECRUITING

Seattle, Washington, 98109, United States
Froedtert Medical College Pulmonary Clinic
COMPLETED

Milwaukee, Wisconsin, 53266, United States
MD Anderson
RECRUITING

Houston, Texas, 77030, United States
Mayo Clinic Rochester
RECRUITING

Rochester, Minnesota, 55905, United States
National Cheng Kung University Hospital
TERMINATED

Tainan, Tainan, Taiwan
Oregon Health & Science University
WITHDRAWN

Portland, Oregon, 97239, United States
Samsung Medical Center
TERMINATED

Seoul, Gyeonggi-do, 06351, South Korea
Seattle Children's Hospital
RECRUITING

Seattle, Washington, 98105, United States
Seoul National University Hospital
TERMINATED

Seoul, Gyeonggi-do, 03080, South Korea
Shanghai Pulmonary Hospital
TERMINATED

Yangpu, Shanghai Municipality, 200433, China
The Johns Hopkins Hospital
WITHDRAWN

Baltimore, Maryland, 21205, United States
UT Southwestern Medical Center
RECRUITING

Dallas, Texas, 75390, United States
University of California Davis Health System
RECRUITING

Sacramento, California, 95817, United States
University of Iowa Health Care
RECRUITING

Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
RECRUITING

Fairway, Kansas, 66205, United States
University of Oklahoma Health Sciences Center
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
University of Pittsburgh Medical Center Health System
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
VCU Health System
RECRUITING

Richmond, Virginia, 23298, United States
Washington University
WITHDRAWN

St Louis, Missouri, 63112, United States
Weill Cornell Medical College
RECRUITING

New York, New York, 10065, United States
Westmead Hospital
TERMINATED

Sydney, New South Wales, 2145, Australia

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