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

NCT03808922 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: DAS181-3-012018-004318-16
• Study Type: interventional
• Target: 274
• Locations: 8 countries
• Sites: 67

Brief 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.

Conditions

Parainfluenza; Immunocompromised; COVID-19; Lower Respiratory Tract Infection

Keywords

Parainfluenza; PIV; Immunocompromised; Lower Respiratory Tract Infection; LRTI; COVID19; SARS-CoV-2; Coronavirus; Ansun

Outcome Measures

Primary Outcomes (2)

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

  Removal of all oxygen support (with stable SpO2)

  by Day 28

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

  Day 14

Secondary Outcomes (18)

• All-cause mortality rate (main study)

  at Day 28

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

  by Day 21

• Time (in days) to RTRA (main study)

  Days 10, 14, 21, 28

• Percent of subjects who achieve clinical stability (main study)

  by Day 28

• Percent of subjects discharged (without mortality and hospice) (main study)

  by Days 14, 21, 28 and 35

Study Arms (6)

Cohort 1 and Cohort 2 Treatment

EXPERIMENTAL

DAS181 4.5mg qd x 7 OR 10 days

Drug: DAS181

Cohort 1 and Cohort 2 Placebo

PLACEBO COMPARATOR

Placebo qd x 7 OR 10 days

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)

Drug: DAS181 OL

Cohort 4

EXPERIMENTAL

DAS181 4.5mg qd x 7 OR 10 days

Drug: DAS181 OL

DAS181 COVID-19 Treatment

EXPERIMENTAL

DAS181 4.5mg q12h x 7 OR 10 days

Drug: DAS181 COVID-19

DAS181 COVID-19 Placebo

PLACEBO COMPARATOR

Placebo q12h x 7 OR 10 days

Drug: Placebo

Interventions

Placebo DRUG

Placebo nebulized qd x 7 OR 10 days

Cohort 1 and Cohort 2 Placebo; DAS181 COVID-19 Placebo

DAS181 COVID-19 DRUG

DAS181 4.5mg nebulized q12h/day x 7 OR 10 days

DAS181 COVID-19 Treatment

DAS181 OL DRUG

DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days \< 40kg

Cohort 3; Cohort 4

DAS181 DRUG

DAS181 4.5mg nebulized qd x 7 OR 10 days

Cohort 1 and Cohort 2 Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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:

Sponsors & Collaborators

• Ansun Biopharma, Inc.: lead

Study Sites (67)

City of Hope cancer Center

Duarte, California, 91010, United States

RECRUITING

UCLA

Los Angeles, California, 90024, United States

ACTIVE NOT RECRUITING

University of California Davis Health System

Sacramento, California, 95817, United States

RECRUITING

University of California San Diego Medical Center

San Diego, California, 92093, United States

WITHDRAWN

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

WITHDRAWN

Sylvester Comprehensive Cancer Center, University of Miami Health System

Miami, Florida, 33136, United States

RECRUITING

Houston Methodist Hospital

Tampa, Florida, 33612, United States

WITHDRAWN

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

Chicago, Illinois, 60611, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

WITHDRAWN

Loyola University Medical Center

Maywood, Illinois, 60153, United States

WITHDRAWN

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kansas Medical Center

Fairway, Kansas, 66205, United States

RECRUITING

Louisiana State University

Shreveport, Louisiana, 71103, United States

COMPLETED

University of Maryland

Baltimore, Maryland, 21201, United States

WITHDRAWN

The Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

WITHDRAWN

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

WITHDRAWN

Universtiy of Michigan

Ann Arbor, Michigan, 48109, United States

WITHDRAWN

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University

St Louis, Missouri, 63112, United States

WITHDRAWN

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

WITHDRAWN

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

WITHDRAWN

Weill Cornell Medical College

New York, New York, 10065, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Novant Health

Winston-Salem, North Carolina, 27103, United States

WITHDRAWN

The Lindner Center- The Christ Hospital

Cincinnati, Ohio, 45219, United States

WITHDRAWN

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45267, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267, United States

WITHDRAWN

The Cleveland Clinic Foundation

Cleveland, Ohio, 44106, United States

WITHDRAWN

St. Elizabeth Youngstown Hospital

Youngstown, Ohio, 44501, United States

WITHDRAWN

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

WITHDRAWN

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

WITHDRAWN

University of Pittsburgh Medical Center Health System

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Kent Hospital

Warwick, Rhode Island, 02886, United States

COMPLETED

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

WITHDRAWN

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Cook Children's

Forth Worth, Texas, 76104, United States

TERMINATED

Texas Health

Forth Worth, Texas, 76104, United States

COMPLETED

Therapeutic Concepts

Houston, Texas, 77004, United States

COMPLETED

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

WITHDRAWN

MD Anderson

Houston, Texas, 77030, United States

RECRUITING

VCU Health System

Richmond, Virginia, 23298, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Froedtert Medical College Pulmonary Clinic

Milwaukee, Wisconsin, 53266, United States

RECRUITING

Westmead Hospital

Sydney, New South Wales, 2145, Australia

TERMINATED

The Wesley Hospital

Auchenflower, Queensland, 4066, Australia

TERMINATED

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3050, Australia

TERMINATED

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

TERMINATED

Shanghai Pulmonary Hospital

Yangpu, Shanghai Municipality, 200433, China

TERMINATED

West China Hospital

Chengdu, Sichuan, 610041, China

TERMINATED

Shulan (Hangzhou) Hospital co., LTD

Hangzhou, Zhejiang, China

TERMINATED

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

TERMINATED

Rigshospitalet

Copenhagen, 2100, Denmark

TERMINATED

Hôpital Henri Mondor

Créteil, Île-de-France Region, 94010, France

TERMINATED

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

TERMINATED

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

TERMINATED

Seoul National University Hospital

Seoul, Gyeonggi-do, 03080, South Korea

TERMINATED

Asan Medical Center

Seoul, Gyeonggi-do, 05505, South Korea

TERMINATED

Samsung Medical Center

Seoul, Gyeonggi-do, 06351, South Korea

TERMINATED

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Gyeonggi-do, 06591, South Korea

TERMINATED

National Cheng Kung University Hospital

Tainan, Tainan, Taiwan

TERMINATED

National Taiwan University Hospital

Zhongzheng, Taipei City, 10002, Taiwan

TERMINATED

MeSH Terms

Conditions

Paramyxoviridae Infections; COVID-19; Coronavirus Infections

Interventions

oplunofusp

Condition Hierarchy (Ancestors)

Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ronald B Moss, MD

  Ansun Biopharma, Inc.

  STUDY CHAIR

Central Study Contacts

Courtney Alcaraz

CONTACT

619-988-2417; cburke@ansunbiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 18, 2019
• Study Start: May 23, 2019
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

TW (2); KR (5); US (49); CN (4); AU (4); DK (1); HK (1); FR (1)