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

May 15, 2026 updated by: Ansun Biopharma, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
274

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2145
        • Terminated
        • Westmead Hospital
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Terminated
        • The Wesley Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3050
        • Terminated
        • Peter MacCallum Cancer Centre
      • Melbourne, Victoria, Australia, 3050
        • Terminated
        • Royal Melbourne Hospital
  • China
    • Shanghai Municipality
      • Yangpu, Shanghai Municipality, China, 200433
        • Terminated
        • Shanghai Pulmonary Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Terminated
        • West China Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Terminated
        • Shulan (Hangzhou) Hospital co., LTD
      • Hangzhou, Zhejiang, China
        • Terminated
        • The First Affiliated Hospital, Zhejiang University School of Medicine
  • Denmark
      • Copenhagen, Denmark, 2100
        • Terminated
        • Rigshospitalet
  • France
    • Île-de-France Region
      • Créteil, Île-de-France Region, France, 94010
        • Terminated
        • Hopital Henri Mondor
  • Hong Kong
    • New Territories
      • Shatin, New Territories, Hong Kong
        • Terminated
        • Prince of Wales Hospital
  • South Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Terminated
        • Seoul National University Bundang Hospital
      • Seoul, Gyeonggi-do, South Korea, 03080
        • Terminated
        • Seoul National University Hospital
      • Seoul, Gyeonggi-do, South Korea, 05505
        • Terminated
        • Asan Medical Center
      • Seoul, Gyeonggi-do, South Korea, 06351
        • Terminated
        • Samsung Medical Center
      • Seoul, Gyeonggi-do, South Korea, 06591
        • Terminated
        • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Taiwan
    • Tainan
      • Tainan, Tainan, Taiwan
        • Terminated
        • National Cheng Kung University Hospital
    • Taipei City
      • Zhongzheng, Taipei City, Taiwan, 10002
        • Terminated
        • National Taiwan University Hospital
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Cancer Center
      • Los Angeles, California, United States, 90024
        • Active, not recruiting
        • UCLA
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Health System
        • Contact:
          • Stuart Cohen, MD
        • Principal Investigator:
          • Stuart Cohen, MD
      • San Diego, California, United States, 92093
        • Withdrawn
        • University of California San Diego Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Withdrawn
        • Children's Hospital Colorado
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Sylvester Comprehensive Cancer Center, University of Miami Health System
      • Tampa, Florida, United States, 33612
        • Withdrawn
        • Houston Methodist Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Chicago, Illinois, United States, 60637
        • Withdrawn
        • University of Chicago
      • Maywood, Illinois, United States, 60153
        • Withdrawn
        • Loyola University Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Health Care
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Medical Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Completed
        • Louisiana State University
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Withdrawn
        • University of Maryland
      • Baltimore, Maryland, United States, 21205
        • Withdrawn
        • The Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02215
        • Withdrawn
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Withdrawn
        • Universtiy of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Principal Investigator:
          • Paschalis Vergidis, MD
    • Missouri
      • St Louis, Missouri, United States, 63112
        • Withdrawn
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Withdrawn
        • University of Nebraska Medical Center
    • New York
      • New York, New York, United States, 10065
        • Withdrawn
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medical College
        • Contact:
          • Rosypriya Kodiyanplakkal, MD
        • Principal Investigator:
          • Rosypriya Kodiyanplakkal, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Contact:
          • Cameron Wolfe, MD
        • Principal Investigator:
          • Cameron Wolfe, MD
      • Winston-Salem, North Carolina, United States, 27103
        • Withdrawn
        • Novant Health
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
      • Cincinnati, Ohio, United States, 45267
        • Withdrawn
        • University of Cincinnati
      • Cincinnati, Ohio, United States, 45219
        • Withdrawn
        • The Lindner Center- The Christ Hospital
      • Cleveland, Ohio, United States, 44106
        • Withdrawn
        • The Cleveland Clinic Foundation
      • Youngstown, Ohio, United States, 44501
        • Withdrawn
        • St. Elizabeth Youngstown Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Withdrawn
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Withdrawn
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center Health System
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Completed
        • Kent Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Withdrawn
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
      • Forth Worth, Texas, United States, 76104
        • Terminated
        • Cook Children's
      • Forth Worth, Texas, United States, 76104
        • Completed
        • Texas Health
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Principal Investigator:
          • Puneet Garcha
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson
      • Houston, Texas, United States, 77004
        • Completed
        • Therapeutic Concepts
      • Houston, Texas, United States, 77030
        • Withdrawn
        • Houston Methodist Hospital
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Health System
        • Contact:
          • Kristin Miller, MD
        • Principal Investigator:
          • Kristin Miller, MD
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53266
        • Recruiting
        • Froedtert Medical College Pulmonary Clinic
        • Contact:
          • Jonathon Truwit, MD
        • Principal Investigator:
          • Jonathon Truwit, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1 and Cohort 2 Treatment
DAS181 4.5mg qd x 7 OR 10 days
Drug: DAS181
DAS181 4.5mg nebulized qd x 7 OR 10 days
Placebo Comparator: Cohort 1 and Cohort 2 Placebo
Placebo qd x 7 OR 10 days
Drug: Placebo
Placebo nebulized qd x 7 OR 10 days
Experimental: Cohort 3
DAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (< 40kg)
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
Experimental: Cohort 4
DAS181 4.5mg qd 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
Experimental: DAS181 COVID-19 Treatment
DAS181 4.5mg q12h x 7 OR 10 days
Drug: DAS181 COVID-19
DAS181 4.5mg nebulized q12h/day x 7 OR 10 days
Placebo Comparator: DAS181 COVID-19 Placebo
Placebo q12h x 7 OR 10 days
Drug: Placebo
Placebo nebulized qd x 7 OR 10 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent of subjects who Return to Room Air (RTRA) (main study)
Time Frame: by Day 28
Removal of all oxygen support (with stable SpO2)
by Day 28
Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)
Time Frame: Day 14
Day 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
All-cause mortality rate (main study)
Time Frame: at Day 28
at Day 28
Percent of subjects who Return to Room Air (RTRA) (main study)
Time Frame: by Day 21
by Day 21
Time (in days) to RTRA (main study)
Time Frame: Days 10, 14, 21, 28
Days 10, 14, 21, 28
Percent of subjects who achieve clinical stability (main study)
Time Frame: by Day 28
by Day 28
Percent of subjects discharged (without mortality and hospice) (main study)
Time Frame: by Days 14, 21, 28 and 35
by Days 14, 21, 28 and 35
Time (in days) to first hospital discharge (without hospice) (main study)
Time Frame: through Day 35
through Day 35
Total number of inpatient days (main study)
Time Frame: up to Day 35
up to Day 35
Baseline SAD-RV infection-related mortality rate (main study)
Time Frame: at Day 28
at Day 28
Baseline SAD-RV infection-related mortality rate (main study)
Time Frame: at Day 35
at Day 35
All-cause mortality rate (main study)
Time Frame: at Day 35
at Day 35
Change in pulmonary function (FEV1% predicted) (main study)
Time Frame: Day 1, Day 7, Day 14, Day 28
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
Day 5, Day 10, Day 21, Day 28
Time to RTRA
Time Frame: Day 10, Day 14, Day 21, Day 28
Day 10, Day 14, Day 21, Day 28
Time to Clinical stability
Time Frame: Day 14, Day 21, Day 28
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
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
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
Day 14, Day 21, Day 28
Time to Death (all causes)
Time Frame: Day 14, Day 21, Day 28
Day 14, Day 21, Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ansun Biopharma, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ronald B Moss, MD, Ansun Biopharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DAS181-3-01
  • 2018-004318-16 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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