RECRUITING

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

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Conditions

Lower Respiratory Tract InfectionParainfluenzaImmunocompromisedCOVID-19PIVLRTICOVID19SARS-CoV-2CoronavirusAnsun

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2019-05-23
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03808922

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia.
  2. 2. Immunocompromised, as defined by one or more of the following:
  3. * Received an autologous or allogeneic hematopoietic stem cell transplantation (HSCT) at any time in the past
  4. * Received a solid organ transplant at any time in the past
  5. * 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
  6. * 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)
  7. 3. Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid dependent respiratory virus
  8. 4. If female, subject must meet one of the following conditions:
  9. * Not be of childbearing potential or
  10. * Be of childbearing potential and have a negative urine/serum pregnancy test and agrees to practice an acceptable method of contraception
  11. 5. Non-vasectomized males are required to practice effective birth control methods
  12. 6. Capable of understanding and complying with procedures as outlined in the protocol
  13. 7. Provides signed informed consent prior to the initiation of any screening or study-specific procedures
  14. 1. Be ≥18 years of age
  15. 2. Provide adequate medical history to permit accurate stratification (but health status may be healthy, high-risk conditions, or immunocompromised).
  16. 3. Prior to SARS CoV 2 infection, has the ability to carry out self-care activities of daily living (basic ADL)
  17. 4. Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with or without contrast, to involve at least 2 lobes of the lung.
  18. 5. Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tract by at least one of the following samples
  19. 6. Satisfy inclusion criteria #1, 4, 5, 6, 7 of the main study
  1. 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. 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. 3. Female subjects breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug
  4. 4. Subjects taking any other investigational drug used to treat pulmonary infection.
  5. 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. 6. Subjects with known hypersensitivity to DAS181 and/or any of its components
  7. 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:
  8. * Has evidence of vital organ failure outside of the lung (e.g., liver, kidney)
  9. * Requires vasopressors to maintain blood pressure
  10. 1. Subjects requiring invasive mechanical, Bi-PAP or CPAP ventilation at randomization.
  11. 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).
  12. 3. Subjects who are known HIV-positive (and not undetectable at most recent HIV RNA assessment)
  13. 4. Subjects who are currently taking immunomodulating biologics (e.g, interferons, interleukin)
  14. 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:
  15. * Have evidence of vital organ failure outside of the lung (e.g., liver, kidney)
  16. * Require vasopressors to maintain blood pressure
  17. 6. Subjects meeting exclusion criteria #2, 3, 5 and 6 of the main study

Contacts and Locations

Study Contact

Lisa Li
CONTACT
858-353-4948
lli@ansunbiopharma.com
Lana Ordonez
CONTACT
lordonez@ansunbiopharma.com

Principal Investigator

Lisa Li
STUDY_DIRECTOR
Ansun Biopharma, Inc.

Study Locations (Sites)

City of Hope cancer Center
Duarte, California, 91010
United States
UCLA
Los Angeles, California, 90024
United States
University of California Davis Health System
Sacramento, California, 95817
United States
University of California San Diego Medical Center
San Diego, California, 92093
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Sylvester Comprehensive Cancer Center, University of Miami Health System
Miami, Florida, 33136
United States
Houston Methodist Hospital
Tampa, Florida, 33612
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
University of Chicago
Chicago, Illinois, 60637
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
University of Iowa Health Care
Iowa City, Iowa, 52242
United States
University of Kansas Medical Center
Fairway, Kansas, 66205
United States
Louisiana State University
Shreveport, Louisiana, 71103
United States
University of Maryland
Baltimore, Maryland, 21201
United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21205
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Universtiy of Michigan
Ann Arbor, Michigan, 48109
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Washington University
Saint Louis, Missouri, 63112
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Weill Cornell Medical College
New York, New York, 10065
United States
Duke University
Durham, North Carolina, 27710
United States
Novant Health
Winston-Salem, North Carolina, 27103
United States
The Lindner Center- The Christ Hospital
Cincinnati, Ohio, 45219
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45267
United States
University of Cincinnati
Cincinnati, Ohio, 45267
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44106
United States
St. Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, 15213
United States
Kent Hospital
Warwick, Rhode Island, 02886
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
Cook Children's
Fort Worth, Texas, 76104
United States
Texas Health
Fort Worth, Texas, 76104
United States
Therapeutic Concepts
Houston, Texas, 77004
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
MD Anderson
Houston, Texas, 77030
United States
VCU Health System
Richmond, Virginia, 23298
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Froedtert Medical College Pulmonary Clinic
Milwaukee, Wisconsin, 53266
United States

Collaborators and Investigators

Sponsor: Ansun Biopharma, Inc.

  • Lisa Li, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2019-05-23
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2019-05-23
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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