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

Last updated: November 18, 2024
Sponsor: Ansun Biopharma, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Bronchitis

Throat And Tonsil Infections

Covid-19

Treatment

Placebo

DAS181 COVID-19

DAS181

Clinical Study ID

NCT03808922
DAS181-3-01
2018-004318-16
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 hematologicmalignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumormalignancies (e.g., lung, breast, brain cancer) at any time in the past

  • Has an immunodeficiency due to congenital abnormality (only applicable tosubjects age < 18 years old) or pre-term birth (only applicable to subjects age ≤ 2 years old)

  1. Has, within 3 days prior to randomization, a confirmed LRTI with a sialic aciddependent respiratory virus

  2. 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 andagrees to practice an acceptable method of contraception

  1. Non-vasectomized males are required to practice effective birth control methods

  2. Capable of understanding and complying with procedures as outlined in the protocol

  3. Provides signed informed consent prior to the initiation of any screening orstudy-specific procedures

For COVID-19 sub study:

  1. Be ≥18 years of age

  2. Provide adequate medical history to permit accurate stratification (but healthstatus may be healthy, high-risk conditions, or immunocompromised).

  3. Prior to SARS CoV 2 infection, has the ability to carry out self-care activities ofdaily living (basic ADL)

  4. Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with orwithout contrast, to involve at least 2 lobes of the lung.

  5. Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tractby at least one of the following samples

  6. Satisfy inclusion criteria #1, 4, 5, 6, 7 of the main study

Exclusion

Exclusion Criteria:

  1. Subjects may not be on hospice care or, in the opinion of the investigator, have alow chance of survival during the first 10 days of treatment

  2. Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), orAlkaline 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 includingmalignancy (primary or metastasis), chronic medications, transplantation, or chronicinfection will not be excluded

  3. Female subjects breastfeeding or planning to breastfeed at any time through 30 daysafter 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 theopinion 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 aconcurrent viral, bacterial, or fungal infection and meet at least one of thefollowing 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 forthe management of symptoms, e.g., fever, are permitted).

  3. Subjects who are known HIV-positive (and not undetectable at most recent HIV RNAassessment)

  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 concurrentviral, bacterial, or fungal infection and meeting at least one of the followingcriteria:

  • Have evidence of vital organ failure outside of the lung (e.g., liver, kidney)

  • Require vasopressors to maintain blood pressure

  1. Subjects meeting exclusion criteria #2, 3, 5 and 6 of the main study

Study Design

Total Participants: 274
Treatment Group(s): 4
Primary Treatment: Placebo
Phase: 3
Study Start date:
May 23, 2019
Estimated Completion Date:
August 31, 2025

Study 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

Connect with a study center

  • Westmead Hospital

    Sydney, New South Wales 2145
    Australia

    Terminated

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • The Wesley Hospital

    Auchenflower, Queensland 4066
    Australia

    Terminated

  • The Wesley Hospital

    Brisbane, Queensland 4066
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3050
    Australia

    Terminated

  • Royal Melbourne Hospital

    Melbourne, Victoria 3050
    Australia

    Terminated

  • Shanghai Pulmonary Hospital

    Yangpu, Shanghai 200433
    China

    Terminated

  • West China Hospital

    Chengdu, Sichuan 610041
    China

    Terminated

  • West China Hospital

    Nanchong, Sichuan 610041
    China

    Site Not Available

  • 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, Ile-de-France 94010
    France

    Terminated

  • Prince of Wales Hospital

    Sha Tin, New Territories
    Hong Kong

    Terminated

  • Samsung Medical Center

    Gangnam-gu, Seoul, Gyeonggi-do 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Jongno-gu, Seoul, Gyeonggi-do 03080
    Korea, Republic of

    Site Not Available

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

    Seocho-gu, Seoul, Gyeonggi-do 06591
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do 13620
    Korea, Republic of

    Terminated

  • Asan Medical Center

    Seoul, Gyeonggi-do 05505
    Korea, Republic of

    Terminated

  • Samsung Medical Center

    Seoul, Gyeonggi-do 06351
    Korea, Republic of

    Terminated

  • Seoul National University Hospital

    Seoul, Gyeonggi-do 03080
    Korea, Republic of

    Terminated

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

    Seoul, Gyeonggi-do 06591
    Korea, Republic of

    Terminated

  • Asan Medical Center

    Songpa-gu, Seoul, Gyeonggi-do 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Gangnam-gu, Seoul 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Jongno-gu, Seoul 03080
    Korea, Republic of

    Site Not Available

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

    Seocho-gu, Seoul 06591
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Songpa-gu, Seoul 05505
    Korea, Republic of

    Site Not Available

  • National Cheng Kung University Hospital

    North District, Tainan
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Zhongzheng, Taipei City 10002
    Taiwan

    Terminated

  • National Taiwan University Hospital

    Zhongzheng Dist., Taipei City 10002
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan,
    Taiwan

    Terminated

  • City of Hope cancer Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • UCLA

    Los Angeles, California 90024
    United States

    Site Not Available

  • University of California Davis Health System

    Sacramento, California 95817
    United States

    Active - Recruiting

  • University of California San Diego Medical Center

    San Diego, California 92093
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Sylvester Comprehensive Cancer Center, University of Miami Health System

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Tampa, Florida 33612
    United States

    Site Not Available

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

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • University of Iowa Health Care

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Fairway, Kansas 66205
    United States

    Active - Recruiting

  • Louisiana State University

    Shreveport, Louisiana 71103
    United States

    Completed

  • The Johns Hopkins Hospital

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Universtiy of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63112
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10065
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Novant Health

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • The Lindner Center- The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • St. Elizabeth Youngstown Hospital

    Youngstown, Ohio 44501
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh Medical Center Health System

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Kent Hospital

    Warwick, Rhode Island 02886
    United States

    Completed

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Cook Children's

    Fort Worth, Texas 76104
    United States

    Terminated

  • Texas Health

    Fort Worth, Texas 76104
    United States

    Completed

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • MD Anderson

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Therapeutic Concepts

    Houston, Texas 77004
    United States

    Completed

  • VCU Health System

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • Froedtert Medical College Pulmonary Clinic

    Milwaukee, Wisconsin 53266
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.