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

Primary Purpose

Lower Respiratory Tract Infection, Parainfluenza, Immunocompromised

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DAS181
Placebo
DAS181 COVID-19
DAS181 OL
Sponsored by
Ansun Biopharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Respiratory Tract Infection focused on measuring Parainfluenza, PIV, Immunocompromised, Lower Respiratory Tract Infection, LRTI, COVID19, SARS-CoV-2, Coronavirus, Ansun

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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)
  3. Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid dependent respiratory virus
  4. 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
  5. Non-vasectomized males are required to practice effective birth control methods
  6. Capable of understanding and complying with procedures as outlined in the protocol
  7. Provides signed informed consent prior to the initiation of any screening or study-specific procedures

For COVID-19 sub study:

  1. Be ≥18 years of age
  2. Provide adequate medical history to permit accurate stratification (but health status may be healthy, high-risk conditions, or immunocompromised).
  3. Prior to SARS CoV 2 infection, has the ability to carry out self-care activities of daily living (basic ADL)
  4. Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with or without contrast, to involve at least 2 lobes of the lung.
  5. Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tract by at least one of the following samples
  6. Satisfy inclusion criteria #1, 4, 5, 6, 7 of the main study

Exclusion Criteria:

  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. 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. Female subjects breastfeeding or planning to breastfeed at any time through 30 days after 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 the opinion 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 a concurrent viral, bacterial, or fungal infection and meet at least one of the following 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 for the management of symptoms, e.g., fever, are permitted).
  3. Subjects who are known HIV-positive (and not undetectable at most recent HIV RNA assessment)
  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 concurrent viral, bacterial, or fungal infection and meeting at least one of the following criteria:

    • Have evidence of vital organ failure outside of the lung (e.g., liver, kidney)
    • Require vasopressors to maintain blood pressure
  6. Subjects meeting exclusion criteria #2, 3, 5 and 6 of the main study

Sites / Locations

  • City of Hope cancer CenterRecruiting
  • UCLARecruiting
  • University of California Davis Health SystemRecruiting
  • University of California San Diego Medical Center
  • Children's Hospital ColoradoRecruiting
  • Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
  • University of Chicago
  • Loyola University Medical CenterRecruiting
  • University of Kansas Medical CenterRecruiting
  • Louisiana State University
  • University of Maryland
  • The Johns Hopkins HospitalRecruiting
  • Brigham and Women's HospitalRecruiting
  • Beth Israel Deaconess Medical Center
  • Universtiy of MichiganRecruiting
  • Mayo Clinic Rochester
  • Washington UniversityRecruiting
  • University of Nebraska Medical Center
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Weill Cornell Medical CollegeRecruiting
  • Duke UniversityRecruiting
  • Novant Health
  • The Lindner Center- The Christ Hospital
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • University of Cincinnati
  • The Cleveland Clinic Foundation
  • St. Elizabeth Youngstown Hospital
  • Oregon Health & Science University
  • University of PennsylvaniaRecruiting
  • University of Pittsburgh Medical Center Health SystemRecruiting
  • Kent Hospital
  • Vanderbilt University Medical Center
  • Cook Children'sRecruiting
  • Texas Health
  • Therapeutic Concepts
  • Baylor College of Medicine
  • MD AndersonRecruiting
  • VCU Health SystemRecruiting
  • Seattle Children's HospitalRecruiting
  • Fred Hutchinson Cancer Research CenterRecruiting
  • Medical College of WisconsinRecruiting
  • Froedtert Medical College Pulmonary ClinicRecruiting
  • Westmead Hospital
  • The Wesley Hospital
  • Peter MacCallum Cancer Centre
  • Royal Melbourne Hospital
  • Shanghai Pulmonary Hospital
  • West China Hospital
  • Shulan (Hangzhou) Hospital co., LTD
  • The First Affiliated Hospital, Zhejiang University School of Medicine
  • Rigshospitalet
  • Hôpital Henri Mondor
  • Prince of Wales Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • National Taiwan University Hospital
  • National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort 1 and Cohort 2 Treatment

Cohort 1 and Cohort 2 Placebo

Cohort 3

Cohort 4

DAS181 COVID-19 Treatment

DAS181 COVID-19 Placebo

Arm Description

DAS181 4.5mg qd x 7 OR 10 days

Placebo qd x 7 OR 10 days

DAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (< 40kg)

DAS181 4.5mg qd x 7 OR 10 days

DAS181 4.5mg q12h x 7 OR 10 days

Placebo q12h x 7 OR 10 days

Outcomes

Primary Outcome Measures

Percent of subjects who Return to Room Air (RTRA) (main study)
Removal of all oxygen support (with stable SpO2)
Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)

Secondary Outcome Measures

All-cause mortality rate (main study)
Percent of subjects who Return to Room Air (RTRA) (main study)
Time (in days) to RTRA (main study)
Percent of subjects who achieve clinical stability (main study)
Percent of subjects discharged (without mortality and hospice) (main study)
Time (in days) to first hospital discharge (without hospice) (main study)
Total number of inpatient days (main study)
Baseline SAD-RV infection-related mortality rate (main study)
Baseline SAD-RV infection-related mortality rate (main study)
All-cause mortality rate (main study)
Change in pulmonary function (FEV1% predicted) (main study)
Time to improved COVID19 clinical status (Sub-study)
Time to RTRA
Time to Clinical stability
Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable
Time to Clinical deterioration
Time to Discharge from hospital (without readmission before Day 28).
Time to Death (all causes)

Full Information

First Posted
January 16, 2019
Last Updated
July 19, 2023
Sponsor
Ansun Biopharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03808922
Brief Title
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ansun Biopharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Respiratory Tract Infection, Parainfluenza, Immunocompromised, COVID-19
Keywords
Parainfluenza, PIV, Immunocompromised, Lower Respiratory Tract Infection, LRTI, COVID19, SARS-CoV-2, Coronavirus, Ansun

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
274 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 and Cohort 2 Treatment
Arm Type
Experimental
Arm Description
DAS181 4.5mg qd x 7 OR 10 days
Arm Title
Cohort 1 and Cohort 2 Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo qd x 7 OR 10 days
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
DAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (< 40kg)
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
DAS181 4.5mg qd x 7 OR 10 days
Arm Title
DAS181 COVID-19 Treatment
Arm Type
Experimental
Arm Description
DAS181 4.5mg q12h x 7 OR 10 days
Arm Title
DAS181 COVID-19 Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo q12h x 7 OR 10 days
Intervention Type
Drug
Intervention Name(s)
DAS181
Intervention Description
DAS181 4.5mg nebulized qd x 7 OR 10 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo nebulized qd x 7 OR 10 days
Intervention Type
Drug
Intervention Name(s)
DAS181 COVID-19
Intervention Description
DAS181 4.5mg nebulized q12h/day x 7 OR 10 days
Intervention Type
Drug
Intervention Name(s)
DAS181 OL
Intervention Description
DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days < 40kg
Primary Outcome Measure Information:
Title
Percent of subjects who Return to Room Air (RTRA) (main study)
Description
Removal of all oxygen support (with stable SpO2)
Time Frame
by Day 28
Title
Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
All-cause mortality rate (main study)
Time Frame
at Day 28
Title
Percent of subjects who Return to Room Air (RTRA) (main study)
Time Frame
by Day 21
Title
Time (in days) to RTRA (main study)
Time Frame
Days 10, 14, 21, 28
Title
Percent of subjects who achieve clinical stability (main study)
Time Frame
by Day 28
Title
Percent of subjects discharged (without mortality and hospice) (main study)
Time Frame
by Days 14, 21, 28 and 35
Title
Time (in days) to first hospital discharge (without hospice) (main study)
Time Frame
through Day 35
Title
Total number of inpatient days (main study)
Time Frame
up to Day 35
Title
Baseline SAD-RV infection-related mortality rate (main study)
Time Frame
at Day 28
Title
Baseline SAD-RV infection-related mortality rate (main study)
Time Frame
at Day 35
Title
All-cause mortality rate (main study)
Time Frame
at Day 35
Title
Change in pulmonary function (FEV1% predicted) (main study)
Time Frame
Day 1, Day 7, Day 14, Day 28
Title
Time to improved COVID19 clinical status (Sub-study)
Time Frame
Day 5, Day 10, Day 21, Day 28
Title
Time to RTRA
Time Frame
Day 10, Day 14, Day 21, Day 28
Title
Time to Clinical stability
Time Frame
Day 14, Day 21, Day 28
Title
Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable
Time Frame
Day 5, Day 10, Day 14, Day 21, Day 28
Title
Time to Clinical deterioration
Time Frame
Day 5, Day 10, Day 14, Day 21, Day 28
Title
Time to Discharge from hospital (without readmission before Day 28).
Time Frame
Day 14, Day 21, Day 28
Title
Time to Death (all causes)
Time Frame
Day 14, Day 21, Day 28

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 Exclusion Criteria: 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 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 Female subjects breastfeeding or planning to breastfeed at any time through 30 days after 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 the opinion 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 a concurrent viral, bacterial, or fungal infection and meet at least one of the following 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 for the management of symptoms, e.g., fever, are permitted). Subjects who are known HIV-positive (and not undetectable at most recent HIV RNA assessment) 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 concurrent viral, bacterial, or fungal infection and meeting at least one of the following criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Li
Phone
858-353-4948
Email
lli@ansunbiopharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Slemons
Email
dslemons@ansunbiopharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Wang
Organizational Affiliation
Ansun Biopharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Davis Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart Cohen, MD
First Name & Middle Initial & Last Name & Degree
Stuart Cohen, MD
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Withdrawn
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Withdrawn
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Medical Center
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Name
Louisiana State University
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Individual Site Status
Completed
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Completed
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shmuel Shoham, MD
First Name & Middle Initial & Last Name & Degree
Shmuel Shoham, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Withdrawn
Facility Name
Universtiy of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Gregg, MD
First Name & Middle Initial & Last Name & Degree
Kevin Gregg, MD
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Terminated
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Withdrawn
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeon Joo Lee, MD
First Name & Middle Initial & Last Name & Degree
Yeon Joo Lee, MD
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosypriya Kodiyanplakkal, MD
First Name & Middle Initial & Last Name & Degree
Rosypriya Kodiyanplakkal, MD
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cameron Wolfe, MD
First Name & Middle Initial & Last Name & Degree
Cameron Wolfe, MD
Facility Name
Novant Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Completed
Facility Name
The Lindner Center- The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Completed
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Completed
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Withdrawn
Facility Name
St. Elizabeth Youngstown Hospital
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Individual Site Status
Completed
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Completed
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh Medical Center Health System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
Kent Hospital
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Individual Site Status
Completed
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cook Children's
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Health
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Completed
Facility Name
Therapeutic Concepts
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Completed
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Terminated
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
VCU Health System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Miller, MD
First Name & Middle Initial & Last Name & Degree
Kristin Miller, MD
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Froedtert Medical College Pulmonary Clinic
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53266
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathon Truwit, MD
First Name & Middle Initial & Last Name & Degree
Jonathon Truwit, MD
Facility Name
Westmead Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Terminated
Facility Name
The Wesley Hospital
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Individual Site Status
Terminated
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Terminated
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Terminated
Facility Name
Shanghai Pulmonary Hospital
City
Yangpu
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Terminated
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Terminated
Facility Name
Shulan (Hangzhou) Hospital co., LTD
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Terminated
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Terminated
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Terminated
Facility Name
Hôpital Henri Mondor
City
Créteil
State/Province
Ile-de-France
ZIP/Postal Code
94010
Country
France
Individual Site Status
Terminated
Facility Name
Prince of Wales Hospital
City
Sha Tin
State/Province
New Territories
Country
Hong Kong
Individual Site Status
Terminated
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Terminated
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Gyeonggi-do
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Terminated
Facility Name
Asan Medical Center
City
Seoul
State/Province
Gyeonggi-do
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Terminated
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gyeonggi-do
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Terminated
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
State/Province
Gyeonggi-do
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Terminated
Facility Name
National Taiwan University Hospital
City
Zhongzheng
State/Province
Taipei City
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Terminated
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Individual Site Status
Terminated

12. IPD Sharing Statement

Learn more about this trial

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

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