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DAS181 for Lower Respiratory Tract Infections and COVID-19 in Immunocompromised Patients

This study is testing a drug called DAS181 for immunocompromised patients with lower respiratory tract infections caused by parainfluenza (a common respiratory virus). It also includes a sub-study for patients with severe COVID-19. You would receive DAS181 or a placebo (an inactive substance) through a nebulizer (a device that turns medicine into a mist you breathe in) for 7 or 10 days. For the COVID-19 sub-study, DAS181 would be given twice a day. The main goal is to see if patients return to breathing room air by day 28. For the COVID-19 sub-study, the goal is to see if your COVID-19 symptoms improve by day 14. To join, you must be immunocompromised and need extra oxygen due to your infection. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 274 participants. It compares DAS181 to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
For the main study, your progress will be followed until Day 28. For the COVID-19 sub-study, your progress will be followed until Day 14.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03808922

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

Recruiting
PHASE3All AgesInterventionalTreatment
Ansun Biopharma, Inc.
~274 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:DAS181PlaceboDAS181 COVID-19DAS181 OL

At a glance

Recruiting sites
19 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of subjects who Return to Room Air (RTRA) (main study)
Measured over by Day 28
+1 more outcome measured

Conditions

Lower Respiratory Tract Infection
Parainfluenza
Immunocompromised
COVID-19

Explore related trials

COVID-19 InfectionImmunodeficiencyLower Respiratory Tract InfectionParainfluenzaCOVID-19 Infection

Where it's being run

28 sites across 22 states
Texas3
Washington3
California2
Gyeonggi-do2
Illinois1
Iowa1
Kansas1
Maryland1

Study leadership

  • Ronald B Moss, MD · STUDY_CHAIR · Ansun Biopharma, Inc.

Who to contact

Courtney Alcaraz
[email protected]
619-988-2417
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Has evidence of vital organ failure outside of the lung (e.g., liver, kidney)
Requires vasopressors to maintain blood pressure
Have evidence of vital organ failure outside of the lung (e.g., liver, kidney)
Require vasopressors to maintain blood pressure

What this trial measures

  • Percent of subjects who Return to Room Air (RTRA) (main study)by Day 28

    Removal of all oxygen support (with stable SpO2)

  • Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)Day 14