NCT03808922 · Ansun Biopharma, Inc.
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
DAS181
DAS181 4.5mg nebulized qd x 7 OR 10 days
DRUG
Placebo
Placebo nebulized qd x 7 OR 10 days
DRUG
DAS181 COVID-19
DAS181 4.5mg nebulized q12h/day 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
Primary outcome measures
Percent of subjects who Return to Room Air (RTRA) (main study)
Time frame: by Day 28
Removal of all oxygen support (with stable SpO2)
Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)
Time frame: Day 14
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 h
Where
- Duarte, California
- Sacramento, California
- Chicago, Illinois
- Iowa City, Iowa
- Fairway, Kansas
- Baltimore, Maryland
- Boston, Massachusetts
- Rochester, Minnesota
- St Louis, Missouri
- New York, New York
- Durham, North Carolina
- Cincinnati, Ohio
And 8 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations