Lower Respiratory Tract InfectionPhase 3NCT03808922
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
A Phase 3 study testing DAS181, DAS181 COVID-19 and DAS181 OL in people with Lower Respiratory Tract Infection and Parainfluenza, run by Ansun Biopharma, Inc. at 28 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lower Respiratory Tract Infection, Parainfluenza, Immunocompromised
- What is being tested?
- DAS181, DAS181 COVID-19 and DAS181 OL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 28 sitesin 5 countries
- Study dates
- 23 May 2019to 1 Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
28 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
28 sites in 5 countries
United States23 sites, 19 recruiting
- Withdrawn
The Johns Hopkins Hospital
Baltimore, Maryland, 21205
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45267
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
City of Hope cancer Center
Duarte, California, 91010
- Recruiting
Duke University
Durham, North Carolina, 27710
Cameron Wolfe, MD
Cameron Wolfe, MD
- Recruiting
University of Kansas Medical Center
Fairway, Kansas, 66205
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Puneet Garcha
- Recruiting
MD Anderson
Houston, Texas, 77030
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242
- Completed
Froedtert Medical College Pulmonary Clinic
Milwaukee, Wisconsin, 53266
- Recruiting
Weill Cornell Medical College
New York, New York, 10065
Rosypriya Kodiyanplakkal, MD
Rosypriya Kodiyanplakkal, MD
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
- Recruiting
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, 15213
- Withdrawn
Oregon Health & Science University
Portland, Oregon, 97239
- Recruiting
VCU Health System
Richmond, Virginia, 23298
Kristin Miller, MD, 804-828-9041, kristin.miller@vcuhealth.org
Kristin Miller, MD
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Paschalis Vergidis, MD
- Recruiting
University of California Davis Health System
Sacramento, California, 95817
Stuart Cohen, MD
Stuart Cohen, MD
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
- Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
- Withdrawn
Washington University
St Louis, Missouri, 63112
South Korea2 sites
- Terminated
Seoul National University Hospital
Seoul, Gyeonggi-do, 03080
- Terminated
Samsung Medical Center
Seoul, Gyeonggi-do, 06351
China1 site
- Terminated
Shanghai Pulmonary Hospital
Yangpu, Shanghai Municipality, 200433
About this study
Official title: A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects
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.
Read the detailed description
Eligible subjects (i.e., those meeting the Inclusion / Exclusion criteria) will be enrolled in one of four cohorts based on the following criteria:
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
- Being tested
- DAS181, Placebo, DAS181 COVID-19, DAS181 OL
- Keywords
- Parainfluenza, PIV, Immunocompromised, Lower Respiratory Tract Infection, LRTI, COVID19, SARS-CoV-2, Coronavirus, Ansun
- Medical subject headings
- Paramyxoviridae Infections, COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAS181Drug
DAS181 4.5mg nebulized qd x 7 OR 10 days
PlaceboDrug
Placebo nebulized qd x 7 OR 10 days
DAS181 COVID-19Drug
DAS181 4.5mg nebulized q12h/day x 7 OR 10 days
DAS181 OLDrug
DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days < 40kg
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 and Cohort 2 Treatment | Experimental | DAS181 4.5mg qd x 7 OR 10 days Receives: Drug: DAS181 |
| Cohort 1 and Cohort 2 Placebo | Placebo comparator | Placebo qd x 7 OR 10 days Receives: Drug: Placebo |
| Cohort 3 | Experimental | DAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (< 40kg) Receives: Drug: DAS181 OL |
| Cohort 4 | Experimental | DAS181 4.5mg qd x 7 OR 10 days Receives: Drug: DAS181 OL |
| DAS181 COVID-19 Treatment | Experimental | DAS181 4.5mg q12h x 7 OR 10 days Receives: Drug: DAS181 COVID-19 |
| DAS181 COVID-19 Placebo | Placebo comparator | Placebo q12h x 7 OR 10 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of subjects who Return to Room Air (RTRA) (main study)
Removal of all oxygen support (with stable SpO2)
Measured: by Day 28
Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)
Measured: Day 14
Secondary outcomes (18)
All-cause mortality rate (main study)
Measured: at Day 28
Percent of subjects who Return to Room Air (RTRA) (main study)
Measured: by Day 21
Time (in days) to RTRA (main study)
Measured: Days 10, 14, 21, 28
Percent of subjects who achieve clinical stability (main study)
Measured: by Day 28
Percent of subjects discharged (without mortality and hospice) (main study)
Measured: by Days 14, 21, 28 and 35
Time (in days) to first hospital discharge (without hospice) (main study)
Measured: through Day 35
Total number of inpatient days (main study)
Measured: up to Day 35
Baseline SAD-RV infection-related mortality rate (main study)
Measured: at Day 28
Baseline SAD-RV infection-related mortality rate (main study)
Measured: at Day 35
All-cause mortality rate (main study)
Measured: at Day 35
Change in pulmonary function (FEV1% predicted) (main study)
Measured: Day 1, Day 7, Day 14, Day 28
Time to improved COVID19 clinical status (Sub-study)
Measured: Day 5, Day 10, Day 21, Day 28
Time to RTRA
Measured: Day 10, Day 14, Day 21, Day 28
Time to Clinical stability
Measured: Day 14, Day 21, Day 28
Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable
Measured: Day 5, Day 10, Day 14, Day 21, Day 28
Time to Clinical deterioration
Measured: Day 5, Day 10, Day 14, Day 21, Day 28
Time to Discharge from hospital (without readmission before Day 28).
Measured: Day 14, Day 21, Day 28
Time to Death (all causes)
Measured: Day 14, Day 21, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start23 May 2019
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ansun Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald B Moss, MD, Study chair, Ansun Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808922
- Sponsor's protocol ID
- DAS181-3-01
- Other IDs
- 2018-004318-16, 2018
- Status last verified
- Jun 2026
- First submitted
- 16 Jan 2019
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects
- ClinicalTrials.gov ID
- NCT03808922
- Acronym / sponsor ID
- DAS181-3-01
- Keywords
- Parainfluenza, PIV, Immunocompromised, Lower Respiratory Tract Infection, LRTI, COVID19, SARS-CoV-2, Coronavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Ansun Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 May 2019 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible subjects (i.e., those meeting the Inclusion / Exclusion criteria) will be enrolled in one of four cohorts based on the following criteria:
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 and Cohort 2 Treatment | Experimental | Drug: DAS181DAS181 4.5mg qd x 7 OR 10 days |
| Cohort 1 and Cohort 2 Placebo | Placebo comparator | Drug: PlaceboPlacebo qd x 7 OR 10 days |
| Cohort 3 | Experimental | Drug: DAS181 OLDAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (< 40kg) |
| Cohort 4 | Experimental | Drug: DAS181 OLDAS181 4.5mg qd x 7 OR 10 days |
| DAS181 COVID-19 Treatment | Experimental | Drug: DAS181 COVID-19DAS181 4.5mg q12h x 7 OR 10 days |
| DAS181 COVID-19 Placebo | Placebo comparator | Drug: PlaceboPlacebo q12h x 7 OR 10 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia.
- Immunocompromised, as defined by one or more of the following:
- 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:
- Non-vasectomized males are required to practice effective birth control methods
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAS181DAS181 4.5mg nebulized qd x 7 OR 10 days | Drug | Cohort 1 and Cohort 2 Treatment |
| PlaceboPlacebo nebulized qd x 7 OR 10 days | Drug | Cohort 1 and Cohort 2 Placebo, DAS181 COVID-19 Placebo |
| DAS181 COVID-19DAS181 4.5mg nebulized q12h/day x 7 OR 10 days | Drug | DAS181 COVID-19 Treatment |
| DAS181 OLDAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days < 40kg | Drug | Cohort 3, Cohort 4 |
Primary outcome
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
18 secondary outcomes
All-cause mortality rate (main study)
Time frame: at Day 28
Percent of subjects who Return to Room Air (RTRA) (main study)
Time frame: by Day 21
Time (in days) to RTRA (main study)
Time frame: Days 10, 14, 21, 28
Percent of subjects who achieve clinical stability (main study)
Time frame: by Day 28
Percent of subjects discharged (without mortality and hospice) (main study)
Time frame: by Days 14, 21, 28 and 35
Time (in days) to first hospital discharge (without hospice) (main study)
Time frame: through Day 35
Total number of inpatient days (main study)
Time frame: up to Day 35
Baseline SAD-RV infection-related mortality rate (main study)
Time frame: at Day 28
Baseline SAD-RV infection-related mortality rate (main study)
Time frame: at Day 35
All-cause mortality rate (main study)
Time frame: at Day 35
Change in pulmonary function (FEV1% predicted) (main study)
Time frame: Day 1, Day 7, Day 14, Day 28
Time to improved COVID19 clinical status (Sub-study)
Time frame: Day 5, Day 10, Day 21, Day 28
Time to RTRA
Time frame: Day 10, Day 14, Day 21, Day 28
Time to Clinical stability
Time frame: Day 14, Day 21, Day 28
Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable
Time frame: Day 5, Day 10, Day 14, Day 21, Day 28
Time to Clinical deterioration
Time frame: Day 5, Day 10, Day 14, Day 21, Day 28
Time to Discharge from hospital (without readmission before Day 28).
Time frame: Day 14, Day 21, Day 28
Time to Death (all causes)
Time frame: Day 14, Day 21, Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronald B Moss, MD study chair
Ansun Biopharma, Inc.
28 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DAS181, DAS181 COVID-19 and DAS181 OL in people with Lower Respiratory Tract Infection and Parainfluenza, run by Ansun Biopharma, Inc. at 28 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, South Korea, Australia, China, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Alcaraz (619-988-2417, cburke@ansunbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of subjects who Return to Room Air (RTRA) (main study) (time frame: by Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.