Actively Recruiting
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
Led by Ansun Biopharma, Inc. · Updated on 2024-11-20
274
Participants Needed
67
Research Sites
327 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Requires supplemental oxygen of 2 liters per minute or more due to low blood oxygen at randomization
- Immunocompromised by one or more of the following: prior hematopoietic stem cell transplant, solid organ transplant, chemotherapy for blood or solid tumors, congenital immunodeficiency (if under 18 years old), or pre-term birth (if 2 years old or younger)
- Confirmed lower respiratory tract infection with a sialic acid dependent respiratory virus within 3 days before randomization
- If female of childbearing potential, negative pregnancy test and agreement to use contraception
- Non-vasectomized males must use effective birth control
- Able to understand and comply with study procedures
- Signed informed consent before any study procedures
- For COVID-19 sub-study: 18 years or older, able to provide medical history, able to perform basic self-care before infection, confirmed lung infection involving at least 2 lobes by CT imaging, laboratory confirmation of SARS-CoV-2 infection, and meet main study criteria #1, 4, 5, 6, 7
You will not qualify if you...
- On hospice care or deemed unlikely to survive first 10 days of treatment
- Elevated liver enzymes (ALT, AST, ALP) 3 times upper limit of normal or more and total bilirubin 2 times upper limit, unless stable for over 1 year due to known liver condition
- Breastfeeding or planning to breastfeed through 30 days after last dose
- Taking other investigational drugs for pulmonary infection
- Psychiatric, cognitive, or substance use issues that affect safety or compliance
- Known allergy to DAS181 or its components
- Severe sepsis with organ failure outside lung or requiring blood pressure support
- For COVID-19 sub-study: on invasive mechanical ventilation, Bi-PAP or CPAP at randomization; receiving other investigational or empiric treatments for SARS-CoV-2; known HIV positive without undetectable viral load; currently taking immunomodulating biologics; severe sepsis with organ failure or blood pressure support; and meeting main study exclusion criteria #2, 3, 5, 6
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 67 locations
1
City of Hope cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
UCLA
Los Angeles, California, United States, 90024
Active, Not Recruiting
3
University of California Davis Health System
Sacramento, California, United States, 95817
Actively Recruiting
4
University of California San Diego Medical Center
San Diego, California, United States, 92093
Withdrawn
5
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Withdrawn
6
Sylvester Comprehensive Cancer Center, University of Miami Health System
Miami, Florida, United States, 33136
Actively Recruiting
7
Houston Methodist Hospital
Tampa, Florida, United States, 33612
Withdrawn
8
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
9
University of Chicago
Chicago, Illinois, United States, 60637
Withdrawn
10
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Withdrawn
11
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Actively Recruiting
12
University of Kansas Medical Center
Fairway, Kansas, United States, 66205
Actively Recruiting
13
Louisiana State University
Shreveport, Louisiana, United States, 71103
Completed
14
University of Maryland
Baltimore, Maryland, United States, 21201
Withdrawn
15
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Withdrawn
16
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
17
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Withdrawn
18
Universtiy of Michigan
Ann Arbor, Michigan, United States, 48109
Withdrawn
19
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
20
Washington University
St Louis, Missouri, United States, 63112
Withdrawn
21
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Withdrawn
22
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Withdrawn
23
Weill Cornell Medical College
New York, New York, United States, 10065
Actively Recruiting
24
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
25
Novant Health
Winston-Salem, North Carolina, United States, 27103
Withdrawn
26
The Lindner Center- The Christ Hospital
Cincinnati, Ohio, United States, 45219
Withdrawn
27
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45267
Actively Recruiting
28
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Withdrawn
29
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44106
Withdrawn
30
St. Elizabeth Youngstown Hospital
Youngstown, Ohio, United States, 44501
Withdrawn
31
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
32
Oregon Health & Science University
Portland, Oregon, United States, 97239
Withdrawn
33
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Withdrawn
34
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
35
Kent Hospital
Warwick, Rhode Island, United States, 02886
Completed
36
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Withdrawn
37
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
38
Cook Children's
Fort Worth, Texas, United States, 76104
Terminated
39
Texas Health
Fort Worth, Texas, United States, 76104
Completed
40
Therapeutic Concepts
Houston, Texas, United States, 77004
Completed
41
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
42
Houston Methodist Hospital
Houston, Texas, United States, 77030
Withdrawn
43
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
44
VCU Health System
Richmond, Virginia, United States, 23298
Actively Recruiting
45
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
46
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
47
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
48
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
49
Froedtert Medical College Pulmonary Clinic
Milwaukee, Wisconsin, United States, 53266
Actively Recruiting
50
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Terminated
51
The Wesley Hospital
Auchenflower, Queensland, Australia, 4066
Terminated
52
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3050
Terminated
53
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Terminated
54
Shanghai Pulmonary Hospital
Yangpu, Shanghai Municipality, China, 200433
Terminated
55
West China Hospital
Chengdu, Sichuan, China, 610041
Terminated
56
Shulan (Hangzhou) Hospital co., LTD
Hangzhou, Zhejiang, China
Terminated
57
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Terminated
58
Rigshospitalet
Copenhagen, Denmark, 2100
Terminated
59
Hôpital Henri Mondor
Créteil, Île-de-France Region, France, 94010
Terminated
60
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Terminated
61
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Terminated
62
Seoul National University Hospital
Seoul, Gyeonggi-do, South Korea, 03080
Terminated
63
Asan Medical Center
Seoul, Gyeonggi-do, South Korea, 05505
Terminated
64
Samsung Medical Center
Seoul, Gyeonggi-do, South Korea, 06351
Terminated
65
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Gyeonggi-do, South Korea, 06591
Terminated
66
National Taiwan University Hospital
Zhongzheng, Taipei City, Taiwan, 10002
Terminated
67
National Cheng Kung University Hospital
Tainan, Taiwan
Terminated
Research Team
L
Lisa Li
CONTACT
L
Lana Ordonez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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