Phase
Condition
Bronchitis
Throat And Tonsil Infections
Covid-19
Treatment
Placebo
DAS181 COVID-19
DAS181
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 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)
Has, within 3 days prior to randomization, a confirmed LRTI with a sialic aciddependent 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 andagrees 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 orstudy-specific procedures
For COVID-19 sub study:
Be ≥18 years of age
Provide adequate medical history to permit accurate stratification (but healthstatus may be healthy, high-risk conditions, or immunocompromised).
Prior to SARS CoV 2 infection, has the ability to carry out self-care activities ofdaily living (basic ADL)
Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with orwithout contrast, to involve at least 2 lobes of the lung.
Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tractby at least one of the following samples
Satisfy inclusion criteria #1, 4, 5, 6, 7 of the main study
Exclusion
Exclusion Criteria:
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
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
Female subjects breastfeeding or planning to breastfeed at any time through 30 daysafter 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 theopinion 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 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:
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 forthe management of symptoms, e.g., fever, are permitted).
Subjects who are known HIV-positive (and not undetectable at most recent HIV RNAassessment)
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 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
- Subjects meeting exclusion criteria #2, 3, 5 and 6 of the main study
Study Design
Study Description
Connect with a study center
Westmead Hospital
Sydney, New South Wales 2145
AustraliaTerminated
Westmead Hospital
Westmead, New South Wales 2145
AustraliaSite Not Available
The Wesley Hospital
Auchenflower, Queensland 4066
AustraliaTerminated
The Wesley Hospital
Brisbane, Queensland 4066
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne, Victoria 3050
AustraliaTerminated
Royal Melbourne Hospital
Melbourne, Victoria 3050
AustraliaTerminated
Shanghai Pulmonary Hospital
Yangpu, Shanghai 200433
ChinaTerminated
West China Hospital
Chengdu, Sichuan 610041
ChinaTerminated
West China Hospital
Nanchong, Sichuan 610041
ChinaSite Not Available
Shulan (Hangzhou) Hospital co., LTD
Hangzhou, Zhejiang
ChinaTerminated
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
ChinaTerminated
Rigshospitalet
Copenhagen, 2100
DenmarkTerminated
Hôpital Henri Mondor
Créteil, Ile-de-France 94010
FranceTerminated
Prince of Wales Hospital
Sha Tin, New Territories
Hong KongTerminated
Samsung Medical Center
Gangnam-gu, Seoul, Gyeonggi-do 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Jongno-gu, Seoul, Gyeonggi-do 03080
Korea, Republic ofSite Not Available
The Catholic University of Korea, Seoul St. Mary's Hospital
Seocho-gu, Seoul, Gyeonggi-do 06591
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
Korea, Republic ofTerminated
Asan Medical Center
Seoul, Gyeonggi-do 05505
Korea, Republic ofTerminated
Samsung Medical Center
Seoul, Gyeonggi-do 06351
Korea, Republic ofTerminated
Seoul National University Hospital
Seoul, Gyeonggi-do 03080
Korea, Republic ofTerminated
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Gyeonggi-do 06591
Korea, Republic ofTerminated
Asan Medical Center
Songpa-gu, Seoul, Gyeonggi-do 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Gangnam-gu, Seoul 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Jongno-gu, Seoul 03080
Korea, Republic ofSite Not Available
The Catholic University of Korea, Seoul St. Mary's Hospital
Seocho-gu, Seoul 06591
Korea, Republic ofSite Not Available
Asan Medical Center
Songpa-gu, Seoul 05505
Korea, Republic ofSite Not Available
National Cheng Kung University Hospital
North District, Tainan
TaiwanSite Not Available
National Taiwan University Hospital
Zhongzheng, Taipei City 10002
TaiwanTerminated
National Taiwan University Hospital
Zhongzheng Dist., Taipei City 10002
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan,
TaiwanTerminated
City of Hope cancer Center
Duarte, California 91010
United StatesActive - Recruiting
UCLA
Los Angeles, California 90024
United StatesSite Not Available
University of California Davis Health System
Sacramento, California 95817
United StatesActive - Recruiting
University of California San Diego Medical Center
San Diego, California 92093
United StatesSite Not Available
Children's Hospital Colorado
Aurora, Colorado 80045
United StatesSite Not Available
Sylvester Comprehensive Cancer Center, University of Miami Health System
Miami, Florida 33136
United StatesActive - Recruiting
Houston Methodist Hospital
Tampa, Florida 33612
United StatesSite Not Available
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United StatesActive - Recruiting
University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
Loyola University Medical Center
Maywood, Illinois 60153
United StatesSite Not Available
University of Iowa Health Care
Iowa City, Iowa 52242
United StatesActive - Recruiting
University of Kansas Medical Center
Fairway, Kansas 66205
United StatesActive - Recruiting
Louisiana State University
Shreveport, Louisiana 71103
United StatesCompleted
The Johns Hopkins Hospital
Baltimore, Maryland 21205
United StatesSite Not Available
University of Maryland
Baltimore, Maryland 21201
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Universtiy of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting
Washington University
Saint Louis, Missouri 63112
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Weill Cornell Medical College
New York, New York 10065
United StatesActive - Recruiting
Duke University
Durham, North Carolina 27710
United StatesActive - Recruiting
Novant Health
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45267
United StatesActive - Recruiting
The Lindner Center- The Christ Hospital
Cincinnati, Ohio 45219
United StatesSite Not Available
University of Cincinnati
Cincinnati, Ohio 45267
United StatesSite Not Available
The Cleveland Clinic Foundation
Cleveland, Ohio 44106
United StatesSite Not Available
St. Elizabeth Youngstown Hospital
Youngstown, Ohio 44501
United StatesSite Not Available
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
Kent Hospital
Warwick, Rhode Island 02886
United StatesCompleted
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
UT Southwestern Medical Center
Dallas, Texas 75390
United StatesActive - Recruiting
Cook Children's
Fort Worth, Texas 76104
United StatesTerminated
Texas Health
Fort Worth, Texas 76104
United StatesCompleted
Baylor College of Medicine
Houston, Texas 77030
United StatesActive - Recruiting
Houston Methodist Hospital
Houston, Texas 77030
United StatesSite Not Available
MD Anderson
Houston, Texas 77030
United StatesActive - Recruiting
Therapeutic Concepts
Houston, Texas 77004
United StatesCompleted
VCU Health System
Richmond, Virginia 23298
United StatesActive - Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United StatesActive - Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United StatesActive - Recruiting
Seattle Children's Hospital
Seattle, Washington 98105
United StatesActive - Recruiting
Froedtert Medical College Pulmonary Clinic
Milwaukee, Wisconsin 53266
United StatesActive - Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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