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

Who is this study for? Patients with a Lower Tract Parainfluenza Infection and Hypoxemia that are Immunocompromised due to Hematopoietic Stem Cell Transplantation
What treatments are being studied? DAS181
Status: Recruiting
Location: See all (67) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

• 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

Locations
United States
California
City of Hope cancer Center
RECRUITING
Duarte
UCLA
ACTIVE_NOT_RECRUITING
Los Angeles
University of California Davis Health System
RECRUITING
Sacramento
University of California San Diego Medical Center
WITHDRAWN
San Diego
Colorado
Children's Hospital Colorado
WITHDRAWN
Aurora
Florida
Sylvester Comprehensive Cancer Center, University of Miami Health System
RECRUITING
Miami
Houston Methodist Hospital
WITHDRAWN
Tampa
Iowa
University of Iowa Health Care
RECRUITING
Iowa City
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
University of Chicago
WITHDRAWN
Chicago
Loyola University Medical Center
WITHDRAWN
Maywood
Kansas
University of Kansas Medical Center
RECRUITING
Fairway
Louisiana
Louisiana State University
COMPLETED
Shreveport
Massachusetts
Beth Israel Deaconess Medical Center
WITHDRAWN
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Maryland
The Johns Hopkins Hospital
WITHDRAWN
Baltimore
University of Maryland
WITHDRAWN
Baltimore
Michigan
Universtiy of Michigan
WITHDRAWN
Ann Arbor
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Missouri
Washington University
WITHDRAWN
St Louis
North Carolina
Duke University
RECRUITING
Durham
Novant Health
WITHDRAWN
Winston-salem
Nebraska
University of Nebraska Medical Center
WITHDRAWN
Omaha
New York
Memorial Sloan Kettering Cancer Center
WITHDRAWN
New York
Weill Cornell Medical College
RECRUITING
New York
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
The Lindner Center- The Christ Hospital
WITHDRAWN
Cincinnati
University of Cincinnati
WITHDRAWN
Cincinnati
The Cleveland Clinic Foundation
WITHDRAWN
Cleveland
St. Elizabeth Youngstown Hospital
WITHDRAWN
Youngstown
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Oregon Health & Science University
WITHDRAWN
Portland
Pennsylvania
University of Pennsylvania
WITHDRAWN
Philadelphia
University of Pittsburgh Medical Center Health System
RECRUITING
Pittsburgh
Rhode Island
Kent Hospital
COMPLETED
Warwick
Tennessee
Vanderbilt University Medical Center
WITHDRAWN
Nashville
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Cook Children's
TERMINATED
Fort Worth
Texas Health
COMPLETED
Fort Worth
Baylor College of Medicine
RECRUITING
Houston
Houston Methodist Hospital
WITHDRAWN
Houston
MD Anderson
RECRUITING
Houston
Therapeutic Concepts
COMPLETED
Houston
Virginia
VCU Health System
RECRUITING
Richmond
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Fred Hutchinson Cancer Research Center
RECRUITING
Seattle
Seattle Children's Hospital
RECRUITING
Seattle
Wisconsin
Froedtert Medical College Pulmonary Clinic
RECRUITING
Milwaukee
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
The Wesley Hospital
TERMINATED
Auchenflower
Peter MacCallum Cancer Centre
TERMINATED
Melbourne
Royal Melbourne Hospital
TERMINATED
Melbourne
Westmead Hospital
TERMINATED
Sydney
China
West China Hospital
TERMINATED
Chengdu
Shulan (Hangzhou) Hospital co., LTD
TERMINATED
Hangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
TERMINATED
Hangzhou
Shanghai Pulmonary Hospital
TERMINATED
Yangpu
Denmark
Rigshospitalet
TERMINATED
Copenhagen
France
Hôpital Henri Mondor
TERMINATED
Créteil
Hong Kong Special Administrative Region
Prince of Wales Hospital
TERMINATED
Shatin
Republic of Korea
Seoul National University Bundang Hospital
TERMINATED
Seongnam-si
Asan Medical Center
TERMINATED
Seoul
Samsung Medical Center
TERMINATED
Seoul
Seoul National University Hospital
TERMINATED
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
TERMINATED
Seoul
Taiwan
National Cheng Kung University Hospital
TERMINATED
Tainan City
National Taiwan University Hospital
TERMINATED
Zhongzheng
Contact Information
Primary
Lisa Li
lli@ansunbiopharma.com
858-353-4948
Backup
Lana Ordonez
lordonez@ansunbiopharma.com
Time Frame
Start Date: 2019-05-23
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 274
Treatments
Experimental: Cohort 1 and Cohort 2 Treatment
DAS181 4.5mg qd x 7 OR 10 days
Placebo_comparator: Cohort 1 and Cohort 2 Placebo
Placebo 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)
Experimental: Cohort 4
DAS181 4.5mg qd x 7 OR 10 days
Experimental: DAS181 COVID-19 Treatment
DAS181 4.5mg q12h x 7 OR 10 days
Placebo_comparator: DAS181 COVID-19 Placebo
Placebo q12h x 7 OR 10 days
Sponsors
Leads: Ansun Biopharma, Inc.

This content was sourced from clinicaltrials.gov